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Job DescriptionPosition Description: Dr. Praegers was founded in 1994 with the mission to bring delicious frozen food to everyone. Its not every day that two heart surgeons get into the food business, but over 20 years ago thats exactly what our dads did. Motivated by what they saw in their practice, our parents set out on a mission to encourage sensible eating. They knew ingredients had to be nutritious and simple, that everything had to be delicious, and that their products needed to be super simple to make. While the world has changed since our little family business first got started, our focus remains true to our dads vision, and we work every day to make them proud. To learn more visit: Dr. Praeger's HistoryResponsibilities: \tResponsible for compliance with all GMPs, Food Safety procedures, and regulatory standards that are established by OSHA, FDA, USDA, and Dr. Praegers Sensible Foods. \tKeep the work area clean. \tResponsible for keeping pallets neat and orderly. \tTransport trash and debris away from production areas. \tMonitor the efficiency of the production line to ensure timely load and shipment. \tAssemble and prepare goods for shipment. \tAbility to follow directions. \tOperate heavy-duty equipment. \tUtilization of Redzone software \tFill out all documentation completely. \tSupport Machine operators as needed. \tStart and stop equipment. Physical requirements: \tAbility to lift and carry at least 50 lbs. \tMust be able to stand/walk for extended periods of time and frequently push, pull, bend, and reach. Skills (required): \tStrong communication skills. \tAbility to work in a team environment. \tBilingual preferred. Disclaimer: Employee must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodation will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship. Dr. Praeger's Sensible Foods is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability, or handicap, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, or any other characteristic protected by applicable federal, state or local laws. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, and general treatment during employment. $16.00 - $16.00 Hourly

Job DescriptionPosition Description: Dr. Praegers was founded in 1992 with the mission to bring delicious frozen food to everyone. Its not every day that two heart surgeons get into the food business, but over 20 years ago thats exactly what our dads did. Motivated by what they saw in their practice, our parents set out on a mission to encourage sensible eating. They knew ingredients had to be nutritious and simple, that everything had to be delicious, and that their products needed to be super simple to make. While the world has changed since our little family business first got started, our focus remains true to our dads vision, and we work every day to make them proud. To learn more visit: Dr. Praeger's HistoryResponsibilities: \tResponsible for compliance with all GMPs, Food Safety procedures, and regulatory standards that are established by OSHA, FDA, USDA, and Dr. Praegers Sensible Foods. \tKeep the work area clean. \tResponsible for keeping pallets neat and orderly. \tTransport trash and debris away from production areas. \tMonitor the efficiency of the production line to ensure timely load and shipment. \tAssemble and prepare goods for shipment. \tAbility to follow directions. \tOperate heavy-duty equipment. \tUtilization of Redzone software \tFill out all documentation completely. \tSupport Machine operators as needed. \tStart and stop equipment. Physical requirements: \tAbility to lift and carry at least 50 lbs. \tMust be able to stand/walk for extended periods of time and frequently push, pull, bend, and reach. Skills (required): \tStrong communication skills. \tAbility to work in a team environment. \tBilingual preferred. Disclaimer: Employee must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodation will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship. Dr. Praeger's Sensible Foods is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, disability, or handicap, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, or any other characteristic protected by applicable federal, state or local laws. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, and general treatment during employment. $16.00 - $16.00 Hourly

Job Description ABOUT ORGANOX: OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx metra® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally. Position Summary We are seeking a passionate and detail-oriented CAPA Manager to lead the administration and reporting of our Corrective and Preventive Action (CAPA) system. This role is pivotal in ensuring that quality issues are addressed effectively and transparently, while fostering a culture of continuous improvement and compliance. The CAPA Manager will not own the CAPA actions themselves but will be responsible for overseeing the CAPA process runs in a manner that is compliant with ISO 13485 and associated regulations, ensuring timely and effective execution by CAPA owners, and reporting progress and effectiveness to senior management. Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive. This is a primarily an on-site position with some hybrid working at OrganOx’s Giralda Farms US site to ensure the administration and reporting of our Corrective and Preventive Action (CAPA) system is lead effectively. Major Responsibilities Under direction from the Director, Quality Assurance, the CAPA Manager will be responsible for: · Administer the end-to-end CAPA process in compliance with regulatory requirements (e.g., ISO 13485, FDA 21 CFR 820). · Lead, coach and develop a direct report to build technical capability, problem-solving skills and ownership of CAPA administration function. · Monitor CAPA progress, ensuring timely closure and effectiveness verification. · Drive a culture of accountability for CAPA owners, ensuring actions are completed on time with scalable and sustainable corrective actions. · Prepare and present CAPA metrics, trends, and insights to senior leadership. Produce regular data driven reports that identify CAPA trends and feed into process, product or system changes. · Facilitate stone cross-functional collaboration to ensure issues are fully understood solutions are well-integrated and learnings are shared across the organization. · Maintain CAPA documentation and ensure audit readiness. · Leverage Continuous Improvement (CI) tools and methodologies to optimise the CAPA process for efficiency, effectiveness and prevention of recurrence. · Drive continuous improvement initiatives based on CAPA learnings. · Champion a team-focused, respectful approach to problem-solving and accountability. · Adhere to the letter and spirit of OrganOx’s Values, Code of Conduct and all other company policies. Requirements Skills & Experience · Effective interpersonal skills to achieve outcomes through influence. · Clear communicator both verbally and in writing. · Ability to process complex data to enable actionable insights. · Demonstrated ability to lead and develop team members, fostering growth and performance. Qualifications · Minimum of bachelor’s degree in a Life Science, Engineering or Technical subject. · At least 2 years’ experience in leading CAPA Management with a proven track record of driving CAPA’s to a timely closure and ensuring sustained effectiveness. · 3-4 years of related work experience in Medical Devices, Pharmaceuticals or other regulated industry. · Experience in eQMS systems such as MasterControl, TrackWise, Windchill or others. · Ability to travel internationally up to 10%. · At least 1 or more years’ of line management experience, managing direct reports. #LI-Hybrid A job description does not imply that the duties stated are the only ones to be performed by the job holder. Job holder will be required to follow any other job-related instruction as reasonably requested by their line manager or their designate. Benefits The Pay Range for this position is $140,000 - $155,000 annually, with a 20% target annual bonus and benefits. We offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work-life balance and provides opportunities for ongoing professional development. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.

Job Description Food Safety and Quality Assurance Manager Sakara Life is a mission-driven, premium wellness brand helping people nourish themselves by providing ready-to-eat nutrition programs, functional products, and unique content to clients nationwide. We are seeking smart, passionate, ambitious, and hardworking team players that share our passion for health & well-being. As the Food Safety and Quality Assurance Manager, you will play an important role in managing all FSQA activities and programs at the facility level, serving as the management representative for all applicable areas within quality and product food safety to ensure that hat we satisfy our customers, comply with local/state/federal and regulatory requirements, and continuously improve our systems, processes, and culture. You’ll love this role if: You’re incredibly organized, detail oriented and have a drive for “getting things done!” You have a “no job too small” mentality with an ability to effectively and professionally interface with Sakara team members and external partners. Responsibilities: Maintain safety, quality and regulatory compliance for food products, adhering to local, state, and federal environmental,SQF, and food safety regulations. Manage the hourly sanitation team and enhance strategic sanitation programs and processes to ensure the facility meets sanitation standards. Champion and provide direction to the high-performing quality and food safety culture as required by means of audits, training, coaching and consultations. Support investigations into any customer or consumer complaints related to food safety and quality assurance. Maintain standard and effectiveness for third party partners: pest control and overnight third-party sanitation. Responsible for invoices. Organize food safety training documentation, execute trainings, and monitor effectiveness of training programs for production team Verify, validate, and maintain documentation as required by our food safety management standard. Assess raw material and finished good suppliers to ensure the quality and regulatory compliance is never jeopardized and work closely with department managers to ensure effective implementation of new products or new practices. Generate reports describing Quality Assurance KPIs, activities, trends, and expenditures as well as communicate findings and action plans to necessary/appropriate parties Coordinate relevant physical, chemical, and microbiological tests on raw materials,finished products, and environmental per specifications Requirements Bachelor's degree, preferred in chemistry, biology, food science, or a related field. A minimum of 5+ years working in food manufacturing or in the restaurant industry, with experience in HACCP, SQF, GFSI, FDA and/or NYS audits. Organic experience a plus. Preventative Control Qualified Individual (PCQI) with knowledge of retail and manufacturing regulatory requirements. Highly organized with excellent documentation management and prioritization skills. Multi-tasker who is multi-faceted and able to juggle multiple projects at once. Act, at all times, with the highest level of character and personal integrity, including demonstrating decorum and professionalism with respect to various confidential matters in the department. Excellent listening and communication skills, both written and verbal. Strong attention to detail and follow-up, ensuring nothing slips through the cracks. Solutions-oriented, team player with a positive attitude, self-confidence and enthusiasm Adaptability and flexibility (including with respect to working additional hours as needed). This is a full time role based in our production facility in LIC. This role will be required to be in the office, Monday through Friday. The Role - Food Safety and Quality Assurance Manager Sakara Life is a mission-driven, premium wellness brand helping people nourish themselves by providing ready-to-eat nutrition programs, functional products, and unique content to clients nationwide. We are seeking smart, passionate, ambitious, and hardworking team players that share our passion for health & well-being. You will be responsible for “turning thoughts into things” and helping manifest the future of Sakara. As the Food Safety and Quality Assurance Manager, you will play an important role in managing all FSQA activities and programs at the facility level, serving as the management representative for all applicable areas within quality and product food safety to ensure that hat we satisfy our customers, comply with local/state/federal and regulatory requirements, and continuously improve our systems, processes, and culture. You’ll love this role if: You’re incredibly organized, detail oriented and have a drive for “getting things done!” You have a “no job too small” mentality with an ability to effectively and professionally interface with Sakara team members and external partners. Responsibilities: Maintain safety, quality and regulatory compliance for food products, adhering to local, state, and federal environmental,SQF, and food safety regulations. Manage the hourly sanitation team and enhance strategic sanitation programs and processes to ensure the facility meets sanitation standards. Champion and provide direction to the high-performing quality and food safety culture as required by means of audits, training, coaching and consultations. Support investigations into any customer or consumer complaints related to food safety and quality assurance. Maintain standard and effectiveness for third party partners: pest control and overnight third-party sanitation. Responsible for invoices. Organize food safety training documentation, execute trainings, and monitor effectiveness of training programs for production team Verify, validate, and maintain documentation as required by our food safety management standard. Assess raw material and finished good suppliers to ensure the quality and regulatory compliance is never jeopardized and work closely with department managers to ensure effective implementation of new products or new practices. Generate reports describing Quality Assurance KPIs, activities, trends, and expenditures as well as communicate findings and action plans to necessary/appropriate parties Coordinate relevant physical, chemical, and microbiological tests on raw materials,finished products, and environmental per specifications Requirements Bachelor's degree, preferred in chemistry, biology, food science, or a related field. A minimum of 5+ years working in food manufacturing or in the restaurant industry, with experience in HACCP, SQF, GFSI, FDA and/or NYS audits. Organic experience a plus. Preventative Control Qualified Individual (PCQI) with knowledge of retail and manufacturing regulatory requirements. Highly organized with excellent documentation management and prioritization skills. Multi-tasker who is multi-faceted and able to juggle multiple projects at once. Act, at all times, with the highest level of character and personal integrity, including demonstrating decorum and professionalism with respect to various confidential matters in the department. Excellent listening and communication skills, both written and verbal. Strong attention to detail and follow-up, ensuring nothing slips through the cracks. Solutions-oriented, team player with a positive attitude, self-confidence and enthusiasm Adaptability and flexibility (including with respect to working additional hours as needed). This is a full time role based in our production facility in LIC. This role will be required to be in the office, Monday through Friday. Sakara Life is proud to be an Equal Opportunity Employer. All persons shall have the opportunity to be considered for employment without regard to their race, color, creed, religion, national origin, ancestry, citizenship status, age, physical or mental disability, sex, gender, gender identity or expression (including transgender status), sexual orientation, marital status, veteran status, genetic information or any other characteristic protected by applicable federal, state or local laws. Salary Range $85,000 - $95,000 Powered by JazzHR fBQZqvsumW

Job Description Job Title: Coating Operator II Department/Division: Manufacturing/Coating Reports to: Manager, Coating About LTS: LTS Lohmann Therapy Systems is a premier, global Contract Development and Manufacturing Organization (CDMO) and partner the pharma industry trusts most to deliver innovative oral, transdermal, and intradermal drug delivery systems. From concept to market, launch to lifecycle management, we deliver single source oral and transdermal drug delivery solutions that power partners’ market advantage. Every one of our 1,000 plus members of the LTS family, across three continents, is focused on utilizing our collective strength and innovation to explore new therapeutic opportunities, maximize partner value and improve patient outcomes. We Care. We Create. We Deliver. Job Summary Lohman Therapy Systems North America is seeking a highly motivated and experienced Machine Operator with a strong focus on coating processes to join our growing team. In this role, you will play a crucial part in the successful production of high-quality products by operating and maintaining various coating equipment, ensuring optimal performance, and maintaining a safe and clean work environment. This is a full-time onsite position located in West Caldwell, NJ • Control and align multiple web paths during manufacturing with tension drive units, pressure rollers, and an edge guiding system., • Perform machine setups and correct machine functions., • Handle raw stock materials with a pallet jack., • Splice materials with a utility knife, tape gun, and splicing table., • Ensure proper disposal of hazardous waste, cleaning solutions, and adhesive compounds., • High school diploma or equivalent., • 4–5 years of machine operator experience, with at least 3 years of GMP manufacturing experience, preferably in the pharmaceutical field., • Experience with coating is preferred., • A strong mechanical aptitude and familiarity with equipment operation., • Strong math skills are a must., • Good reading, writing, and verbal skills., • Good computer skills to navigate systems and fill out necessary forms and documents., • Knowledge of laminating pressures for various types of films, fabrics, and foams., • Knowledge of Corona Treatment. LTS is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Job DescriptionJob Title: Quality Inspector – Food Manufacturing Location: Bright-eyed Department: Quality Assurance Reports To: Director of Operation Schedule: 10am to 6pm (Weekend Availability) Status: Full-Time Position Summary: We are seeking a detail-oriented and highly responsible Quality Inspector to join our growing food manufacturing team. This role is critical to ensuring the safety, compliance, and quality of a diverse portfolio of products including chocolates, kitchen-prepared foods, re-packaged dry goods, oils, spices, syrups, coffee, nuts, tea, rice, ice cream, new dishes, juices, and more. The ideal candidate will uphold rigorous food safety standards, conduct thorough inspections, and support continuous improvement in line with regulatory requirements and internal quality expectations. Key Responsibilities: • Perform routine and random inspections of raw materials, in-process production, and finished goods across all product categories., • Ensure all products meet established quality specifications, including taste, appearance, weight, temperature, packaging integrity, and labeling accuracy., • Conduct environmental monitoring and sanitation checks, ensuring adherence to HACCP, GMPs, and other food safety protocols., • Monitor equipment and production lines for proper operation and cleanliness; report any non-compliance or deviations., • Complete and maintain accurate inspection records, logs, and quality documentation., • Support traceability and lot control by verifying product codes, batch records, and documentation throughout the facility., • Collect and test samples for microbiological, physical, and chemical parameters as required., • Escalate any product defects, contamination risks, or critical issues immediately to supervisors or the Quality Manager., • Collaborate with production, warehouse, and kitchen teams to maintain quality awareness and ensure compliance during all shifts., • Participate in internal audits, third-party inspections, and corrective action follow-ups., • Assist with training employees on basic food safety practices and quality procedures., • Support continuous improvement and help drive initiatives that reduce waste and improve consistency and customer satisfaction.Required Qualifications:, • High school diploma or equivalent; college-level coursework or certification in Food Science, Quality Assurance, or a related field is a plus., • Minimum 1–2 years of quality inspection or food safety experience in a food manufacturing environment., • Strong understanding of GMPs, HACCP, SQF, and FDA/USDA regulations., • Ability to work in cold, hot, or humid environments and handle a fast-paced, multi-product operation., • Excellent observational, analytical, and communication skills., • Strong attention to detail, organizational skills, and ability to document accurately., • Proficient in Microsoft Office (Word, Excel) and comfortable with using inspection tools and digital systems., • Bilingual (English/Spanish) is a plus. But not required.Physical Requirements:, • Ability to stand, walk, bend, and lift up to 50 lbs., • Ability to work in environments ranging from freezers to hot kitchens., • Comfortable wearing PPE and following safety protocols at all times.What We Offer:, • Competitive hourly rate and benefits package, • Opportunities for growth and advancement, • Supportive and inclusive work environment, • On-the-job training and professional development

Job Description Hi, we're Nuts.com! Nuts.com is a self-funded, profitable, rapidly growing multi-channel DTC specialty food and wellness company with over 550 people on our team. We're changing the landscape of snacking on nuts, dried fruit, chocolate and more! We planted our roots in Newark, New Jersey during the Great Depression, selling premium nuts on Mulberry Street's open-air market. We've come quite a long way since then, taking our multi-generational family business online in 1999. Even after 96 years, we continue to pride ourselves in expertly sourcing the highest quality foods and treating our customers like family. What's our team like? We're driven, collaborative and entrepreneurial. Energy and passion power our business and we look for candidates who share in that excitement to help us continue to build something special. The role: The Industrial Maintenance Technician is responsible for the installation, maintenance, troubleshooting, and repair of industrial equipment and machinery in a food processing plant. This position ensures that all equipment operates efficiently and in compliance with food safety regulations, company standards, and best practices. The role requires a strong understanding of mechanical, electrical, and electronic systems, as well as the ability to perform preventative maintenance and corrective repairs. This is a full-time position with scheduled hours from Sunday through Thursday, 11:00 AM to 7:30 PM. What you'll do: Maintenance and Repairs • Perform routine and preventive maintenance on all production machinery, equipment, and systems (conveyors, packaging equipment, mixers, roasters, etc), • Diagnose mechanical, electrical, and hydraulic issues and make necessary repairs, • Ensure all equipment complies with safety, regulatory, and environmental standards, • Maintain safe work practices and ensure compliance with OSHA and food safety regulations (e.g., SQF, FDA), • Complete maintenance logs and reports to ensure accurate documentation, • Work closely with production teams to minimize downtime and maximize productivity, • Communicate effectively with supervisors and management to report issues and recommend improvements, • Assist with the installation of new machinery or equipment, • Respond quickly to emergency breakdowns to minimize production delays, • Prioritize repairs to ensure minimal impact on production schedules What you'll bring: • High School Diploma or equivalent; Associate's degree in Industrial Maintenance, Electrical Engineering, or related field preferred, • Minimum 3 years of experience in industrial maintenance, preferably in a food processing or manufacturing environment, • Strong knowledge of electrical, mechanical, hydraulic, and pneumatic systems, • Demonstrated experience with VFFS, HFFS, standup pouch baggers, and associated combination scales, • Bilingual Preferred (Spanish, English), • Ability to lift up to 50 lbs regularly and perform physical tasks such as bending, kneeling, and standing for extended periods, • Ability to work in a noisy, fast-paced, and sometimes hot or cold environment, • Certifications (preferred, but not required): Forklift certification, OSHA safety training, and electrical and/or mechanical certifications What we offer • A high-growth and rewarding role in a foundationally strong and rapidly evolving business, • Hourly Pay Range: $25 - $30/hour based on experience, • Excellent benefits including a 401K Match, • Paid Maternity, Adoption and Paternity leave, • And all the Nuts.com snacks your heart desires + a 40% employee discount EEO STATEMENT Nuts.com is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, immigration status, age, sex or gender (including pregnancy), gender identity or expression (including transgender status), sexual orientation, marital status, veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws. Applicants with disabilities who require assistance or accommodation during the application or interview process should reach out to us at

Regulatory A Regulatory Affairs expert is needed for effective integration of the recently acquired Energy Drinks Brand. This person will complete reviews and approvals of ingredients, formulations, labels and artwork to ensure compliance with all applicable FDA regulations. Most urgently there will be artwork redesign across the portfolio in the back half of 2020 where assessment of all technical label content, claims and associated website changes will be completed. This will be followed end of 2020 and throughout 2021 with work to support the reformulation of existing products, new innovation as well as integration of Client into our Product Vision System and with our Bottlers. The request is for an 18 month contract to complete this work. The position will require excellent understanding and application of US FDA and USDA regulations to ensure the ultimate accuracy of finished product ingredient statements, nutrition facts, allergen declarations and claims. They must be able to monitor, interpret and ensure compliance with US regulations today and into the future. Ideally, the incumbent has experience in working with R&D's ProductVision (PV) and artwork systems. Qualifications: • BS Degree in Food Science, Regulatory, Nutrition, or equivalent as minimum, • Corporate or government regulatory experience in US FDA and USDA food labeling and solid background in nutrition related field with strong collaboration and communication skills, • Minimum of 3 years food regulation experience, global regulatory experience is a bonus., • Detail oriented; adaptable; with ability to work independently desired, • Excellent computer skills and existing knowledge of Product Vision System highly preferred (Wave, WINLIMS, Microsoft Office experience preferred). Must be quick to learn new systems., • Project management, communication with on-sight project management team and direct communication with vendor regulatory teams is required to validate accuracy of information before population into the system. Strong technical regulatory background is essential to success.

Job DescriptionSr. Manager/ Associate Director Document & Change ManagementAllendale, NJ The Senior Manager Documentation & Change Management will assist with the overall leadership and implementation of global Document Management and Control and the Change Control Management program designed to comply with applicable laws and regulations. This position has accountability for development and oversight of global quality documents, the structure of the program, and the design, implementation and continuous improvement of electronic document management systems. This position also has responsibility for oversight of the regional Change Management system and accountability for the design, implementation, administration, and continuous improvement of the electronic change management system. • Responsible for the development of systematic control and management processes for GxP documents throughout their lifecycle and for establishing procedures to ensure records (paper and electronic) are maintained in compliance with global regulatory and legal requirements, as well as site requirements and procedures., • Responsible and accountable for the development, deployment and implementation of effective and efficient standards, procedures, and best practices for global and site documentation management and control including periodic review, change process, retention and archival., • Maintains the global Quality Manual and global Quality Standards, and any associated global policies, reports, or documents., • Assists in developing the overall global Quality Standards strategy and implementing the quality documentation hierarchy for global and site documentation, including development of process for gap assessments and implementation planning., • Engages process owners and SMEs to ensure quality standards are appropriately defined, implemented, and/or updated to include current regulatory strategy and are contemporaneous with industry standards., • Leads the development of reporting on quality standards implementation across all functions., • Accountable for development and management of effective documentation system KPIs, metrics, management review, and proactive issue identification and resolution., • Partners, educates, and collaborates with Documentation Control, QA, and SOP authors/owners in other functional areas for the development, deployment and maintenance of the document management program and records retention schedule., • Business process owner for the electronic documentation management system. Partner with IT to implement, administer, maintain, and continuously improve the electronic documentation management system., • Manages the document change request system at the global and regional level and provides guidance at the site level., • Provides support during internal and external audits, including Regulatory Health Authority inspections., • Ensures the documentation system is scalable and flexible to support initiatives and communicates effectively with all cross functional and regional stakeholders on matters related to the documentation system and e-DMS.Change System Management:, • Serves as subject matter expert for the regional change control system and associated requirements., • Develops standards and guidelines for change control inputs and requirements needed to support change control requests., • Oversees and administers the Change Control Board for regional/global Change Control requests and provides guidance at the site level., • Leads the electronic change management governance process and serves as administrator to the e-system., • Interfaces with IT as the Business Process Owner for the electronic change management system. Develops and prioritizes system enhancements and added functionality based on business need., • As needed, works Quality Assurance and functional area representatives or responsible change owners to develop change management strategies., • Develops and provide reports on change management process and progress for global dashboard., • This role may have direct reports. The role also functions as an individual contributor role in a heavily matrixed environment., • Incumbent will be expected to complete all assigned GxP and Compliance related training in accordance with assigned due dates., • Phone conferences outside of normal working hours is required in order to interact with global counterparts., • Travel is required at approximately 15%.REQUIREMENTS, • BA/BS in the Life Sciences is required. MS degree in Life Sciences a plus., • 7-10+ years experience in Document Management and Control and 3-5 years experience in Change Management in FDA-regulated, GxP-related Industry is required., • Comprehensive knowledge of document control principles, data integrity principles, and good documentation practices a must., • Demonstrated experience with implementation and management of electronic document management systems required., • Working knowledge of electronic change management systems or e-QMS required., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Ability to drive Quality projects for continuous improvement., • Thorough knowledge of ICH Guidelines and FDA cGMPs and Guidelines is required., • Knowledge of European and Japanese Health Authority requirements is a plus., • Ability to work independently with minimal supervision is required., • Demonstrated ability to interact and communicate effectively with peers, senior management, regulatory officials, and auditors. Proven interpersonal skills with face to face and remote teams., • Position will be filled at level commensurate with experience., • Strong computer skills are required., • Excellent oral, written, and verbal communication skills are required.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description Leadman & Associates is excited to present an opportunity for a detail-driven and compliance-focused Regulatory & Compliance Manager to step into a newly created role with a growing global alcohol and beverage manufacturing organization. This hybrid role is based out of their plant in the NYC, NY area. It's a great fit for someone who thrives in documentation-heavy work, knows the TTB process inside and out, and is ready to build structure in a newly defined regulatory function. If you're passionate about innovation, compliance, and being the go-to regulatory expert for multiple markets, this role offers a rare opportunity to step into a pivotal seat and make an immediate impact. Why You Should Consider This Opportunity: * High Compensation + Bonus: Competitive pay structure with a 15% target bonus * Hybrid Schedule: 3 days on-site, 2 days remote * Newly Created Role: Build the structure, process, and strategy from the ground up * Global Impact: Work across U.S., Canadian, and international markets (supporting 10+ export regions) * Cross-Functional Exposure: Collaborate with Legal, R&D, Marketing, Ops, and Global Innovation * Well-Rounded Benefits: Comprehensive health coverage, 401(k) match, PTO, parental leave, and more! In This Role, You Will: * Serve as the primary regulatory lead for all North American innovation and new product development * Own formula and label submissions to TTB, LCBO, SAQ, and other regulatory bodies * Oversee compliance documentation related to liquid, packaging, labeling, and product claims * Ensure regulatory readiness from benchtop to market launch across domestic and export markets * Partner with external vendors, co-mans, and flavor houses to ensure documentation and compliance * Monitor changes in FDA, USDA, TTB, Health Canada, and global alcohol/food regulations * Lead risk assessments, manage timelines, and advise cross-functional partners What You Bring to the Table: * Bachelor's degree in Food Science, Nutrition, or a related technical field * 3–5 years of experience in regulatory affairs or quality assurance within alcohol, beverage, or food/CPG * Strong knowledge of TTB regulations, especially formula and COLA submissions * Experience with packaging and liquid compliance documentation * Understanding of FDA, USDA, Health Canada, and international regulatory requirements * Attention to detail and documentation- this is a compliance-heavy role, not a legal strategy role * Confident communicator who can simplify complex technical details for cross-functional teams * Comfortable working in a fast-paced, matrixed organization with evolving priorities Must be a U.S. Citizen or authorized to work in the U.S. Interested in learning more? Reach out to Leadman & Associates at .

Job Description Customs Brokerage Manager (Remote) Preferred: New York area (remote candidates welcome) Full-Time | Salary: $85,000–$100,000/year Join a well-established international logistics firm seeking a seasoned Customs Brokerage Department Managerto lead and manage a high-performing team of four. This is a fully remote position, ideal for a candidate with strong leadership experience in customs brokerage and hands-on entry processing. Key Responsibilities: • Oversee daily operations of the Customs Brokerage Department, ensuring compliance and efficiency, • Lead a team of four (including licensed brokers), with one upcoming retirement creating a key leadership gap, • Manage and process customs entries (approx. 325–350 entries/month), • Monitor and interpret tariff changes, customs regulations, and trade compliance updates, • Keep the department fully informed and trained on regulatory changes, • Work directly in CargoWise to manage processes and data, • Maintain departmental performance metrics and drive continuous improvement Qualifications:, • Required: Prior experience managing a customs brokerage department, • Preferred: Licensed U.S. Customs Broker, • Proficient in CargoWise software (required), • Strong knowledge of U.S. Customs regulations and HTS classification, • Willingness to be both a hands-on contributor and strategic team leader, • Excellent communication, compliance, and leadership skills Requirements Qualifications • 5–10 years of experience in customs brokerage or import operations within the freight forwarding industry, • CargoWise experience is required, • Strong knowledge of HTS classification, CBP regulations, and PGA requirements, • Experience with FDA codes, Lacey Act entries, and DDP procedures, • Excellent communication, problem-solving, and organizational skills, • Salary: $85,000 – $100,000 based on experience, • Vacation: 10 business days annually, • 401(k): 3% company contribution (eligible after 1 year, with enrollment windows on Jan 1 and July 1), • Health Insurance: Offered after 2 months of employment

Job DescriptionTitle: Regulatory Affairs Supervisor Reports to: Manager, Regulatory Affairs Department: Quality Assurance/ Quality Control Responsibilities: • Assist the Manager during cGMP, Environmental, and Regulatory audits., • Assist the Manager to create and collate product master files (dossiers), drug master files (DMF)., • Generate and Review of CoCs, CoAs, CoMs, BSE documents, CMR documents, RM Certificate of Analysis, RM Safety Data Sheet, RM technical documents, RM composition breakdown, as may be required for local and international submissions., • Generate Raw Material Regulatory statement: Origin Statement, Clean List, Sephora, Ulta, Cruelty Free statement, Heavy metal statement, Impurity statement, REACHCompliant Statements, Global and regional Compliance statements, Food allergen statement, Fragrance allergen statement, Nitrosamine-free Statement, EU/Chinacompliant statement, etc. (as applicable)., • Responsible for Gluten free, organic (USDA/ Ecocert) regulatory submission and share updated regulation within team members., • Manage communication with Vendors/suppliers for RM documents and follow up on request with vendors., • Ability to use in-house and 3rd party portal to generate compliance documents, product information packets, Product / Formulary SDS, Toxicology statements, etc, as applicable., • Review formulas, ingredients, and associated documents for compliance with designated regulatory filings and proposed submissions. Notify heads of quality and R&D (or designee) regarding any discrepancies or deficiencies with filings and items intended for submissions., • Co-ordinate investigations (audit findings, etc); correspondences to regulatory audits; and registration of products and facility with agencies., • Ensure compliance to all SOPs and other regulatory requirements (e.g. FDA, EPA, OSHA, TGA, Japan, Health Canada, ISO, EU, China CSAR, etc)., • Responsible for facility registrations, renewals, and document submissions to regulatory agencies under the direct supervision of the Head of Quality., • Assist the Manager during periodic regulatory reviews, regulatory updates, and annual GMP training., • Familiar with SOPs generation process, Specification controls, and Change Control program., • Familiar with quality management system (QMS) in compliance with US 21CFR 210, 211., • Maintain familiarity with changing global regulatory requirements., • Minimum of Bachelor degree (Life Sciences, Engineering, related profession)., • Experience of drug, cosmetic, or medical device regulatory is a pre-requisite., • Familiarity with FDA requirements under 21CFR 210, 211, & 820 is a pre-requisite., • Three + years industry or related experience in any combination of cosmetic, medical device, food, or pharma is required., • Previous regulatory, inspecting, auditing or manufacturing experience - a plus., • Data analysis skills - a plus., • Computer literate and effective communication skills., • Ability to lift and carry up to 10-15 pounds.Compensation & Benefits:, • Pay range: $67,000 - $72,000 per year, • Medical, Dental, and Vision Insurance, • Life Insurance, • 401k match, • PTO Powered by JazzHR CE9lUZzcQa

Job Description We are conducting a search for an experienced Director of Quality Control / Quality Assurance to lead and manage our quality programs in a fast-paced, high-volume food manufacturing environment. The ideal candidate is a certified SQF Practitioner with a proven track record of successful third-party, regulatory, and customer audits, and extensive experience in both foodservice and retail segments. This leadership role is critical to ensuring our products consistently meet the highest standards of safety, quality, and compliance. What You'll Do: • Direct and oversee all QC/QA activities across food manufacturing operations., • Maintain and improve the company’s SQF program; act as the designated SQF Practitioner., • Lead all audit activities (SQF, FDA, , customer, and third-party), ensuring successful outcomes and timely resolution of non-conformities., • Implement and monitor HACCP plans, food safety systems, GMPs, SOPs, and other quality-related programs., • Supervise and develop the QA/QC team; drive a culture of accountability and continuous improvement., • Partner with cross-functional teams including Operations, R&D, and Supply Chain to optimize product quality and efficiency., • Ensure thorough documentation, traceability, and compliance across all quality-related functions., • Manage and respond to customer complaints, deviations, and corrective/preventive actions (CAPAs)., • Monitor industry trends and regulatory updates to ensure ongoing compliance. What You'll Bring: • Bachelor’s degree in Food Science, Microbiology, or related field., • Certified SQF Practitioner (REQUIRED)., • Minimum 10 years of QA/QC experience in the food manufacturing industry, with leadership responsibilities., • Demonstrated success managing quality in both foodservice and retail channels., • Proven track record of passing regulatory, third-party, and customer audits., • Deep understanding of HACCP, GMPs, FSMA, FDA regulations., • Strong organizational, communication, and leadership skills., • Ability to thrive in a high-speed, hands-on manufacturing environment., • Experience with refrigerated, shelf-stable, or specialty food products is a plus., • Bilingual (English and Spanish) is a plus

Job Description Job description Granulation Technology, Inc. is a leading pharmaceutical manufacturer specializing in high-quality OTC (over-the-counter) products. As a fast-growing, Indian-owned and majority women-owned company, we are committed to excellence, innovation, and customer satisfaction. Role Overview: We are seeking a results-driven Pharmaceutical OTC Sales Representative to expand our market presence, secure new accounts, and maintain strong relationships with key customers. This is an exciting opportunity for a sales professional with experience in the pharmaceutical OTC industry. Responsibilities: ✅ Identify and develop new sales opportunities within the OTC pharmaceutical market. ✅ Build and maintain relationships with distributors, retailers, and healthcare providers. ✅ Present and promote our OTC products to potential clients. ✅ Negotiate contracts, pricing, and supply agreements. ✅ Stay updated on industry trends, competitor activity, and market demands. ✅ Collaborate with internal teams (marketing, regulatory, and logistics) to ensure customer satisfaction. ✅ Meet or exceed sales targets and KPIs. Qualifications: Experience: 10+ years in OTC pharmaceutical sales. Skills: Strong negotiation, relationship-building, and communication skills. Knowledge: Familiarity with the OTC market, retail distribution, and pharmacy channels. Self-Motivated: Ability to work independently and drive results. Travel: Willingness to travel as needed for client meetings and industry events. Why Join Us? ✨ Opportunity to work with a growing pharmaceutical company. ✨ Competitive salary with uncapped commission potential. ✨ Flexible work environment with career growth opportunities. ✨ Be part of a dynamic, diverse, and innovative team. Company DescriptionGranulation Technology Inc is in the business of chemical and pharmaceutical manufacturing and distribution company that has been in business since 1997 successfully serving small to Fortune 500 companies. GTI is an FDA GDUFA listed facility. It is a fully functional 35,000 sq. ft. cGMP facility. DEA registered to handle Class II – V controlled substances. We have been consistently adding to our large list of clienteles ensuring their high demands for quality & safety standards in their products are met. At Granulation Technology, Inc. we strive to provide the highest quality products that comply with FDA regulations, meet USP and are manufactured under GMP and ISO standards. This approach ensures high quality products while providing cost competitive advantages.Granulation Technology Inc is in the business of chemical and pharmaceutical manufacturing and distribution company that has been in business since 1997 successfully serving small to Fortune 500 companies. GTI is an FDA GDUFA listed facility. It is a fully functional 35,000 sq. ft. cGMP facility. DEA registered to handle Class II – V controlled substances. We have been consistently adding to our large list of clienteles ensuring their high demands for quality & safety standards in their products are met. At Granulation Technology, Inc. we strive to provide the highest quality products that comply with FDA regulations, meet USP and are manufactured under GMP and ISO standards. This approach ensures high quality products while providing cost competitive advantages.

Job DescriptionSupplier Quality AuditorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Supplier Quality Auditor ensures and promotes compliance through external auditing of company's suppliers; vendors/ laboratory services/service providers/manufacturers for the Allendale, NJ and Mountain View, CA sites based on company's procedures and external regulatory requirements, including but not limited to current FDA Quality System Regulations; 21 CFR Parts 210/211 (cGMP), 21 CFR Part 1271 (GTP), 21 CFR Parts 50/54/56/312 (GCP), 21 CFR Pat 58 (GLP), ICH Q7, Q9, Q10, 21 CFR Part 11 and Data Integrity and Eudralex Volume 4 Guidelines.The Supplier Quality Auditor position will be responsible for the development of a risk-based auditing program for company and management of the Approved Supplier List. The Supplier Quality Auditor will conduct external supplier/vendor/manufacturer audits and harmonize the supplier qualification process across all sites. The Supplier Quality Auditor supports qualification initiatives, continuous improvement, and regulatory compliance across all sites. • Develop and maintain a risk-based external auditing program for company harmonized across all sites., • Perform GAP analyses of the Approved Supplier List (ASL) of suppliers used at all company facilities to ensure complete profile., • Management of ASL to add suppliers and maintain approval status of all suppliers as needed., • Based on ASL status, conduct reviews and perform audits to qualify each supplier used., • Prepare external audit schedule and conduct audits per the schedule., • Prepare and complete audit reports and communicate audit information to cross functional teams within company and supplier within a timely manner., • Ensure adequate CAPAs are developed by suppliers and monitor CAPA closures., • Track audit findings for suppliers to completion and ensure timely closure of audit reports., • Act as a quality lead and liaison between suppliers and internal teams to identify new suppliers and identify and communicate issues that may impact quality, system gaps or cause interruptions in business continuity., • Maintain metrics on supplier audit findings used for oversight, qualification status, continuous improvement, and/or opportunities for reduction/alternate suppliers., • Maintain audit files and ensure all files are properly archived., • Author and review External Auditing, Supplier Qualification and Supplier Management Program and/or Quality Systems SOPs, as needed., • Ensure that Quality Agreements are generated and enforced at each supplier., • Ensure and promote compliance with applicable regulations (e.g., cGMPs, GTPs, etc.) and company and client SOPs., • Assist in other Quality System related responsibilities and provide Quality related support to various departments, as needed.REQUIREMENTS, • Minimum 5-8 years quality systems auditing experience in pharmaceutical, biologics, or medical device industry., • Auditor qualifications and certifications such as Certified Quality Auditor (CQA)/ASQ Certification, ISO Certification, etc., • Experience with auditing raw materials/excipients, components, and analytical and micro laboratories., • Proven ability to identify, collaborate, and resolve supplier related compliance issues., • In-depth knowledge and understanding of current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), ICH Q10, 21 CFR Part 11, Good Tissue Practices (GTPs) and Data Integrity principles,, • EU and PMDA regulations knowledge and associated guidelines are a plus., • Bachelor’s Degree in the chemistry or biological sciences, engineering, or life sciences., • Certified Auditor or Lead Auditor credentials required., • Understanding of the manufacture and testing of cellular and gene therapies is desirable., • Working knowledge of routine laboratory operations, equipment and systems, production processes, and validation., • Experience in Quality Assurance, including the ability to identify and resolve compliance issues., • Sound knowledge of aseptic processing and supporting technologies., • Must have exceptional written and oral communication skills., • Exhibit professional mannerisms when dealing with Clients/Suppliers and company personnel, • Ability to multi-task is essential., • Proficiency with IT skills, such as MS Office (Word, Excel, Outlook, PowerPoint) and SharePoint., • Ability to think strategically and tactically (strong detail-oriented)., • Strong collaborative and influencing skills and ability to work well in a cross-functional, team matrixed environment as well as independent contributor., • Strong analytical and problem-solving skills., • Flexible and able to adapt to company growth and evolving responsibilities., • Multi-disciplinary knowledge across GxP functional areas., • Excellent organizational skills including efficiency, punctuality and attention to detail and managing multiple priorities., • Good verbal, written communication, and presentation skills., • Demonstrable multitasking, project management, and execution skills., • Good business acumen and strong team-oriented interpersonal skills, including communication, presentation, negotiation, influence., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to handle the standard/moderate noise of the manufacturing facility, • Travel required (approx. 50%)Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionPSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech®, it’s about more than just a job—it’s about your career and your future. Your Role We are excited to accept applications for future opportunities. Join our talent pool for future openings by applying now. This is a W2-Temp 6-month role with potential FTE extension.We are seeking a highly skilled and detail-oriented Quality Assurance Engineer to join our team in the life science sector. The ideal candidate will have a strong background in quality assurance processes, with specialized experience in auditing, ensuring compliance with regulatory standards, and maintaining the highest quality standards in pharmaceutical production. This individual will play a crucial role in the review and assessment of manufacturing practices, quality control systems, and regulatory compliance within a highly regulated environment. • Develop, implement, and maintain quality assurance processes and procedures in alignment with industry standards and regulations., • Ensure all manufacturing processes comply with relevant regulations, including but not limited to FDA, EMA, ICH, and GMP guidelines., • Review batch records, validation documentation, and quality control data to ensure compliance and product quality., • Conduct internal and external audits to assess compliance with Good Manufacturing Practices (GMP), FDA regulations, and other relevant standards., • Collaborate with cross-functional teams to ensure effective implementation of audit findings and continuous improvement initiatives., • Prepare detailed audit reports, CAPA (Corrective and Preventive Actions) reports, and other documentation as required., • Maintain thorough and accurate records of quality assurance activities, audits, and regulatory communications., • Participate in the preparation and review of SOPs, work instructions, and other quality-related documents., • Lead or participate in continuous improvement initiatives, focusing on quality and operational efficiency. Requirements • Bachelor's degree in engineering or related technical field., • Minimum of 5+ years of experience in quality assurance within the life science industry., • Proven experience in conducting GMP audits, both internal and external, in a pharmaceutical or life sciences environment., • Experience with regulatory bodies such as the FDA, EMA, and other international regulatory agencies., • Familiarity with Quality Management Systems (QMS), CAPA, deviation management, and risk management., • Strong understanding of GMP regulations, FDA guidelines, and other applicable industry standards., • Excellent analytical and problem-solving skills., • Exceptional attention to detail and ability to identify potential areas of risk and non-compliance., • Strong verbal and written communication skills, with the ability to prepare clear and concise reports., • Travel is required. At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally. Equal Opportunity Employment Statement PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law. #LI-RW1 BenefitsW2 Temp positions include our medical and sick time benefits. Adhering to the requirements of New Jersey's law on salary transparency, the salary bracket for this role is set between $100,000 - $115,000 annually. The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.

Job Description Who we are: For over 20 years, Global Relay has set the standard in enterprise information archiving with industry-leading cloud archiving, surveillance, eDiscovery, and analytics solutions. We securely capture and preserve the communications data of the world's most highly regulated firms, giving them greater visibility and control over their information and ensuring compliance with stringent regulations. Though we offer competitive compensation and benefits and all the other perks one would expect from an established company, we are not your typical technology company. Global Relay is a career-building company. A place for big ideas. New challenges. Groundbreaking innovation. It's a place where you can genuinely make an impact – and be recognized for it. We believe great businesses thrive on diversity, inclusion, and the contributions of all employees. To that end, we recruit candidates from different backgrounds and foster a work environment that encourages employees to collaborate and learn from each other, completely free of barriers. Your role: Join Global Relay, a leading provider of compliance software solutions, as we embark on an exciting journey to expand our footprint in the healthcare and life sciences industry. We're seeking a seasoned Senior Account Executive to drive sales growth and establish strong relationships with key decision-makers in this critical sector. Our cutting-edge compliance software solutions are designed to help healthcare organizations and life sciences companies maintain regulatory compliance, ensure data security, and optimize legal and compliance operations. With a strong focus on archiving and surveillance needs, our solutions address the complex challenges of HIPAA, FDA regulations, and other industry-specific requirements. As a Senior Account Executive, you will play a critical role in identifying and addressing the unique needs of these organizations, demonstrating the value of our solutions, and guiding them through the sales process. The ideal candidate will have a proven track record in software sales, specifically in compliance-related solutions, and a strong understanding of the regulatory landscape within healthcare and life sciences. You will work closely with prospects to identify their unique needs, demonstrate the value of our solutions, and guide them through the sales process from initial engagement to closing. Your responsibilities: • Sales & Business Development:, • Prospect, identify, and target new business opportunities in the healthcare and life sciences verticals with a focus on compliance-related archiving and surveillance solutions., • Develop and execute strategic sales plans to meet or exceed annual revenue targets., • Lead the full sales cycle, including prospecting, needs assessment, product demonstrations, proposal development, negotiations, and closing deals., • Consultative Selling & Solution Design:, • Conduct in-depth needs assessments with prospective clients to understand their challenges related to data archiving, eDiscovery, surveillance, and regulatory compliance., • Provide expert consultation on how our software solutions can address their specific compliance requirements, streamline workflows, and mitigate risk., • Build and maintain strong, long-term relationships with key decision-makers at healthcare organizations and life sciences companies., • Industry Knowledge & Regulatory Expertise:, • Stay informed about the latest industry trends, regulations, and compliance standards (e.g., HIPAA, FDA regulations, 21 CFR Part 11, GxP, GDPR, DOJ) affecting the healthcare and life sciences sectors., • Use your knowledge of the healthcare and life sciences industries to clearly articulate the benefits and value of compliance-focused archiving and surveillance solutions., • Collaboration & Reporting:, • Collaborate with cross-functional teams, including marketing, customer success, and revenue operations, to align on sales strategies and customer needs., • Provide regular updates on sales progress, pipeline status, customer feedback, and market trends to management., • 7-10+ years of experience in sales, with a strong focus on compliance software solutions, preferably in the healthcare and life sciences industries., • Experience with archiving, surveillance, or compliance-related software solutions is preferred., • Exceptional consultative selling skills, with the ability to understand complex customer requirements and translate them into tailored software solutions., • Strong understanding of regulatory compliance and guidance in the healthcare and life sciences sectors (e.g., HIPAA, FDA, 21 CFR Part 11, DOJ ECCP)., • Bachelor's degree in Business, Life Sciences, Healthcare Administration, Computer Science, Risk Management, or a related field., • Knowledge of Salesforce, Zoom Info, LinkedIn Sales Navigator, and Demandbase are preferred., • Strong communication, presentation, and negotiation skills., • Ability to build relationships with C-level executives, IT professionals, Legal, and Compliance officers., • Self-starter with a goal-oriented mindset and the ability to thrive in a fast-paced, target-driven environment. Compensation: Global Relay advertises the pay range for this role in compliance with applicable pay transparency laws. Individual pay rates are determined by evaluating factors such as expertise, skills, education, and professional background. The range below reflects the expected annual base salary, which is only one element of our comprehensive total rewards package designed to reflect our company pay philosophy, culture and values. We aim to foster an inspiring work environment and support employees' work-life rhythms. We provide a comprehensive health benefits program, including extended health coverage, and short-term / long-term disability insurance. Employees receive annual allotted vacation days, which increase based on tenure. Other benefits include paid sick days, maternity/parental leave enhanced program, commuter benefits, and a 401(k)-retirement plan with company contribution matching. This role is also eligible for a commission structure. For employees at our New York office, we provide additional perks and amenities to enhance your work experience including a subsidized meal program, courtesy of our in-house culinary team! Base salary$150,000—$200,000 USD What you can expect: At Global Relay, there's no ceiling to what you can achieve. It's the land of opportunity for the energetic, the intelligent, the driven. You'll receive the mentoring, coaching, and support you need to reach your career goals. You'll be part of a culture that breeds creativity and rewards perseverance and hard work. And you'll be working alongside smart, talented individuals from diverse backgrounds, with complementary knowledge and skills. Global Relay is an equal-opportunity employer committed to diversity, equity, and inclusion. We seek to ensure reasonable adjustments, accommodations, and personal time are tailored to meet the unique needs of every individual. We understand flexible work arrangements are important, and we encourage that in our work culture. Whether it's flexibility around work hours, workstyle, or lifestyle, we want to ensure our employees have a healthy work/life balance. We support and value a hybrid work model that blends collaboration with the team in the office and focus time from the comfort of your home. To learn more about our business, culture, and community involvement, visit .

Job DescriptionJob Title: Formulation Scientist Job Description The Formulation Scientist will be responsible for researching, generating, and directing new product formulations from conceptualization through development and manufacture. The role involves collaboration with sales, operations, and quality assurance teams to generate innovative formulations, troubleshoot technical issues, and ensure proper documentation for new product development. The position also requires the development of recipes and prototypes to drive new concepts forward. Responsibilities • Research, generate, and direct new product formulations from concept through to manufacture., • Collaborate with sales to create new formulations for customers and assist in new product development., • Work with operations teams to troubleshoot technical, formulation, and processing issues., • Collaborate with the Quality Assurance department to develop documentation for new projects., • Utilize knowledge of production equipment like tablet presses and capsule filling machines to solve product performance issues., • Troubleshoot and solve issues with tablet and capsule manufacturing processes., • Initiate Label Copy for supplement facts and regulatory requirements., • Drive and manage all aspects of product development, integrating consumer insights., • Collaborate with sales and marketing to develop product quote processes., • Source and identify new concepts, ingredients, and product forms., • Maintain competitive knowledge regarding new technologies, ingredients, and product forms., • Prepare materials and present new launches at sales meetings., • Participate in product and package configuration activities., • Ensure adherence to company SOPs and quality control protocols., • Effectively communicate technical information to non-technical audiences., • Participate in public relations, media interviews, trade shows, and similar events with prior management approval., • Prioritize and manage multiple customer products., • Perform other assigned duties.Essential Skills, • Proven experience in formulation, chemistry, and laboratory practices., • Strong understanding of GMP, quality control, and FDA regulations., • Ability to develop vitamin and supplement products and research ingredients., • Experience in improving product flavor and quality consistency., • Proficiency in integrating from bench to batch production., • Experience in directing production adjustments to formulation and machinery., • Bachelor’s degree in Chemistry, Engineering, Food Science, Nutrition/Dietetics, or related field., • Minimum of 3 years of hands-on experience as a Formulator in a manufacturing environment, preferably in dietary supplements or food & beverage industry., • Strong working knowledge of basic lab techniques and cGMP standards., • Ability to read and interpret safety rules, operating and maintenance instructions, and SDS sheets., • Strong oral and written communication skills.Additional Skills & Qualifications, • Strong knowledge of ingredient costing and technology., • Ability to perform arithmetic operations using whole numbers, fractions, and decimals., • Understanding of simple statistical methods., • Ability to solve moderately complex problems with multiple variables., • Acute sense of documentation within the manufacturing environment., • Proficiency in Microsoft Word and Excel., • Strong presentation skills to communicate new product ideas persuasively., • Ability to work effectively in a cross-functional team environment.Work Environment The work environment requires the ability to lift up to 50 pounds unassisted, or up to 100 pounds with mechanical assistance. The role involves standing, walking, bending, and stooping for long periods, as well as moving and examining objects at various heights. The position demands normal visual acuity and involves reading for extended periods. A high level of organization and the ability to prioritize effectively are essential, along with demonstrated attention to detail and thoroughness. Strong leadership skills, sound judgment, and decision-making abilities are critical. The work schedule is from 7am to 3pm. Job Type & Location This is a Contract to Hire position based out of Fairfield, New Jersey. Pay and Benefits The pay range for this position is $60.00 - $85.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Fairfield,NJ. Application Deadline This position is anticipated to close on Oct 10, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

Job Description Principal Investigator Key Responsibilities: • Oversee and manage all aspects of clinical trials conducted at the research site, ensuring adherence to the study protocol, Good Clinical Practice (GCP), ICH guidelines, and all applicable regulatory requirements., • Provide medical oversight and ensure the safety and well-being of study participants throughout the trial., • Participate in the selection and evaluation of study protocols, ensuring feasibility and alignment with site capabilities., • Lead and supervise the clinical research team, including sub-investigators, study coordinators, and other site staff., • Delegate study-related duties appropriately to qualified personnel and ensure proper training and oversight., • Conduct remote review of patient assessments, including physical exams, medical histories, and eligibility screenings, to ensure appropriate participant enrollment., • Review and interpret laboratory results, ECGs, and other diagnostic tests., • Make critical medical decisions regarding participant care, adverse events, and protocol deviations., • Ensure accurate, complete, and timely collection and documentation of all study data., • Communicate effectively with sponsors, Contract Research Organizations (CROs), Institutional Review Boards (IRBs), and regulatory authorities., • Manage investigational product accountability, storage, and administration according to protocol and with the help of the on-site IP team., • Participate in site initiation visits, monitoring visits, audits, and inspections., • Maintain continuous medical education and stay current with advancements in clinical research and relevant therapeutic areas. Position Requirements: • Medical Doctor (M.D. or equivalent) degree from an accredited institution., • Current, unrestricted medical license in the state of practice., • Board certification in a relevant specialty preferred., • Experience (e.g., 5+ years) as a Principal Investigator or Sub-Investigator in clinical research trials across various therapeutic areas., • Demonstrated in-depth knowledge of ICH-GCP guidelines, FDA regulations, and other relevant ethical and regulatory requirements for clinical research., • Proven leadership and team management skills., • Excellent clinical judgment and decision-making abilities., • Strong verbal and written communication skills in English, with the ability to present complex information clearly and concisely., • Exceptional organizational skills and meticulous attention to detail., • Ability to manage multiple complex studies simultaneously and prioritize tasks effectively., • Commitment to ethical conduct and patient safety. Location: This position requires remote oversight of clinical research sites and may require occasional travel for meetings, conferences, or training 1 to 2 times per month.

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . The Preclinical Principal Scientist will serve as a key scientific contributor, subject matter expert (SME) and Project Manager in the execution of Cresilon’s Preclinical Research Operations, including but not limited to in-vivo study design (Safety and Efficacy/Functionality evaluations), Preclinical Research Management, Vendor Management, and Preclinical Regulatory Strategy. This will include the development and execution of strategies for preclinical evidence necessary to competitively position a project’s product for domestic and international regulatory and clinical acceptance. This position as a hybrid role, with work off-site at CRO in NY/NJ area, work from home and on-site at Brooklyn NY. Job Responsibilities: The Preclinical Research Scientist will: • Lead, staff, and manage Cresilon’s Preclinical Research activities., • Provide preclinical scientific input and leadership on the evaluation of physical safety and efficacy for technologies and products at all stages of the product life cycle., • Plan, direct, coordinate and execute activities related to the design, initiation and follow-up of studies to support approval of Class I-III medical devices., • Develop, write, and/or review study protocols and reports. Act as technical mentor for the development of study experimental designs, protocols, and reports of junior associates., • Administrate and manage Cresilon preclinical regulatory strategy and communication., • Work with Contract Research Organizations (CROs) to execute both Biocompatibility / Safety and Efficacy/Functionality research, including negotiating, drafting, and managing research contracts and agreements with pre-clinical trial sites., • Ensure that company operates within the scope of regulatory compliance including Quality System Regulations (ISO 13485), health and safety, environmental protection regulations, and the core values of Cresilon., • Be a Subject Matter Expert (SME) for preclinical research department growth strategy. Actively interact with the internal and external scientific community to maintain state of the art knowledge., • Oversee the development of and modifications to preclinical models to address project needs., • Oversee the design and execution of preclinical functionality and safety in-vivo studies per project timelines., • Surveys the literature to identify and compare competitive product performance and safety risks., • Maintain current knowledge in existing regulations, requirements and standards, including but not limited to global regulatory requirements (ISO, FDA, etc) and compliance requirements (GLP, USDA, AAALAC, departmental SOP's, company policies, etc), • Work cross functionally with Regulatory and Quality to assess project risks, product safety and efficacy on NPD projects, including ensuring external facilities meet Cresilon standards for animal use and generating contracts and CRO audits, if necessary., • Manage budgetary requirements for all research projects to support efficacy and safety programs., • Lead the effort to publish surgical research in peer-reviewed journals., • Regularly interface with management to ensure research operations reflect overall corporate vision/strategy., • DVM, PhD or MD in a relevant discipline is preferred. A Bachelor's in a technical or scientific field is required., • Minimum 6+ years’ experience in preclinical medical device research is required, preference given to veterinary surgical or human surgical experience., • 4+ years of people management experience preferred., • Extensive knowledge of surgery, anatomy, toxicology, and pathology is required., • Experience with planning, directing, and coordinating activities related to studies to support approval of Class I-III medical devices is highly preferred., • Experience in a medical device, pharmaceutical, or related setting with a proven record of success in supporting studies for R&D projects is highly preferred., • Strong knowledge of ISO-10993 Standards, FDA Guidance and Regulations, and Animal Welfare Regulations., • Experience with surgical publication submission strategy is strongly preferred., • Strong communication skills (both written and verbal) is required with the ability to extract key facts from complex information and present concise summaries to management., • Demonstrated experience with large animal in vivo surgical research and CRO vendor management is required., • Previous experience in authoring and reviewing nonclinical regulatory documents as well as interactions with regulatory authorities is strongly preferred., • Excellent problem solving, conflict resolution, and analytical skills is required., • Ability to work effectively both independently and collaboratively in a dynamic team-oriented environment is required., • Prior experience and ability to work well with external CROs and collaborators with professionalism and discretion is required., • Requires strong leadership and organizational skills including attention to detail and multi-tasking skills., • Able to understand and execute to project details but keep overall “big picture” view of projects, priorities, and strategies is required., • Medical Device product development experience, including knowledge of medical device regulations, regulatory/notified body requirements is preferred., • Good Laboratory Practices (GLP) experience preferred and working knowledge of Good Manufacturing Practices (GMP), • Experience in developing and commercializing regulated devices under Design Control (21 CFR 820) requirements, GLP/GMP, and ISO regulations is preferred., • Hands-on research experience with hemostatic devices and/or coagulation chemistry, strongly preferred., • Legal authorization to work in the United States., • This position is located in Brooklyn, NY and may require up to 30% travel (to monitor and execute out-sourced studies) Cresilon is an equal-opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits • Competitive annual base salary range of $130,000 - $210,000, depending upon job level and qualifications., • Paid Vacation, Sick, & Holidays, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage, • Company Paid Life and Short-Term Disability Coverage, • Work/Life Employee Assistance Program, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - Compass Pathways. Job overview: The Technical Writer, CMC will be responsible for document writing, authoring, and compiling of CMC reports and the CMC sections for regulatory (NDA) filings. This position will work closely with the cross-functional teams within Quality, Clinical and Regulatory Affairs to ensure all CMC technical writing objectives are met. Location: Hybrid in our New York City office or remote on the East Coast, USA. Reports to: Vice-President, Manufacturing and Supply. Roles and responsibilities (Include but are not limited to): • Author and/or review technical reports as required by CMC staff, • Author, compile, and manage CMC sections of regulatory submissions (IND/NDA), • Effectively manage the integrated drafting and reviewing process to meet appropriate timelines, • Ensure all documents comply with regulatory guidelines, company standards, and industry best practices, • Work closely with cross-functional teams to gather input and feedback for report content and formatting, • Minimum of bachelor's degree in chemical, and/or, biological Sciences/relevant discipline, • Over 3 years' experience in technical writing for CMC regulatory filings (especially NDA), • Strong working knowledge of full CMC spectrum, including drug substance and drug product manufacturing, stability requirements, analytical and formulation development and GMP manufacturing considerations in general, • Knowledge of FDA, EMA and global regulations including ICH guidelines with a strong knowledge of eCTD elements and structure, • Demonstrated ability to translate technical information from mixed sources into written information suitable for regulatory authorities, • Excellent verbal/written communication skills; detail/accuracy oriented, • Proven planning and organizational skills and regulatory writing skills Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity. 【Base salary per annum】:$120,000—$170,000 USDBenefits & Compensation: For an overview of our benefits package and compensation information, please visit "Working at Compass". Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Job Description Tester/Quality Assurance Location: Whippany, NJ--onsite Duration: 3 Months+ A Quality Assurance (QA) Technician in the food industry is responsible for ensuring that food products meet established safety, quality, and regulatory standards. This role is vital for maintaining product consistency, preventing contamination, and protecting consumer health. Key Responsibilities: • Testing and Inspection: Conducting routine and specialized tests on raw materials and finished products. They also perform inspections of production areas to verify sanitation and adherence to good manufacturing practices (GMPs)., • Documentation and Record Keeping: Maintaining accurate and detailed records of test results, inspection findings, corrective actions, and other relevant information for audits, traceability, and regulatory compliance., • Compliance Monitoring: Ensuring that all production activities adhere to established food safety regulations, including those set by the FDA and USDA, and implementing HACCP plans when necessary. They also monitor adherence to other food safety programs like GMPs., • Collaboration: Work closely with production staff, quality control team, and other relevant departments to ensure consistent quality and food safety., • Attention to Detail: Must be highly detail-oriented to accurately assess products and document findings., • Problem-Solving Skills: Able to identify potential problems, analyze their causes, and develop solutions., • Communication Skills: Effective communication is crucial for conveying information about quality issues and corrective actions., • Knowledge of Food Safety Standards: A solid understanding of food safety principles and regulations (like HACCP) is essential., • Technical Skills: Basic computer skills, including proficiency in Excel, Word, and Microsoft Outlook, are often required.

Job Description Our client in Fairfield, NJ is looking for an onsite, direct hire Manufacturing Industrial Engineer. Pay: $120k-$130k The ideal candidate will have an engineering background in mechanical engineering, industrial engineering, systems engineering, value engineering, or related engineering field with concentrated technical knowledge and previous experience in precision metals and plastics manufacturing and/or complex finished device assemblies. Responsibilities: • This role is fundamentally based on long-standing best practices in industrial engineering principles: identifying waste, defining value streams, productivity optimization, kanban setups, takt time studies, labor tracking, ergonomics, material flow, pFMEA, and similar Lean Six Sigma tools., • Support new business development with the purpose of generating accurate and detailed costing proposals that exceed customer expectations for quality, price, and delivery., • Bachelor's degree in Engineering (Mechanical, Industrial engineering, Systems engineering, Value engineering), • Minimum of 5 years of experience in value engineering, industrial engineering, manufacturing costing, or related role in the manufacturing industry, with specific experience utilizing industry 4.0 best practices and/or Lean, • Experience working for a Contract Manufacturer or OEM, • Strong engineering background with a solid understanding of manufacturing processes, materials, and equipment, • Ability to identify the best possible manufacturing processes, • Proficiency in using SolidWorks or equipment CAD/CAM software packages for estimating and DFM purposes, • Experience in product level design for manufacture (DFM), • Ability to collaborate across engineering Centers of Excellence for multi-plant vertically integrated proposals, • Excellent analytical and problem-solving skills, • Strong attention to detail and accuracy, • Effective communication and interpersonal skills, • Ability to work independently and as part of a cross-functional team, • Knowledge of industry standards and best practices in cost estimation

Job DescriptionQuality Assurance Compliance InvestigatorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the (Associate) Manager of Quality Assurance (Floor support). Responsible to perform Quality Assurance Compliance activities in support of company and/or client procedures, including but not limited to, document. management: investigations, CAPA, SOPs, qualification and validation reports, QC data. Supports Quality management with various department, organizational and operational excellence initiatives. Generally, exercises independent judgment, within generally defined practices and policies, when selecting methods and techniques for obtaining solutions. This role supports internal and external audits which may include interaction with Health Authorities and clients. • Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) to conduct investigation and CAPA processes., • Conduct investigation and identify true root cause using appropriate tools., • Manage multiple investigations in different stages of the process to meet compliance deadlines and product release dates., • Reviews and approves investigations and CAPAs when required;, • Collaborate with cross functional department to develop and track CAPA plans., • Prepares and issues change control as necessary., • Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company’s processes and procedures., • Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations., • Conducts trend analysis of compliance related metrics such as deviations and CAPAs., • Performs supplemental investigations and/or participates in project teams or assignment as necessary., • Support in agency, internal and/or client audits., • Other duties as assigned.REQUIREMENTS, • B.S in biological sciences or other relevant field of study., • Minimum 5 years’ experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Familiar with FDA, ISO, and other regulatory agency guidelines., • Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required., • Working knowledge and technical understanding of aseptic manufacture of biologics preferred., • Experience in both clinical and commercial manufacturing is preferred., • Experience in supporting health authority inspections and/or client audits preferred., • Competencies/Candidate Profile, • Relevant computer skills (Microsoft Office, Outlook), • Detail-oriented and organized, • Analytical and problem-solving skills, • Good written and oral communication skills, • Ability to multi-task and be adaptable, • Flexible and able to adapt to company growth and evolving responsibilities, • Ability to work independently and with a team, • Strong Project Management and organization skills, • Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit., • Must be able to work in a team-oriented environment., • Must be able to work occasional weekends, nights, and/or holidays as required/necessary., • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids., • Must be able to handle the standard moderate noise of the manufacturing facility., • Must be able to work in open floor plan environment and may work in close proximity to others., • Wheel-o-Vator available for use. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job Description About Bobbie Bobbie is creating a parenting culture of confidence, not comparison. And it starts with how we choose to feed our babies. We crafted our European style infant formula with purposefully sourced, organic ingredients to give parents a product they are proud to feed their babies, direct to their doorstep. Bobbie is proud to be the only US formula that is designed to meet both FDA and EU standards. Although 83% of parents turn to formula in the first year of their baby's life, this is the silent majority that is often shamed for not being able to exclusively breastfeed. Co-founded by two moms and created by a team of mom scientists, nutritionists, pediatricians, and lactation consultants, the Bobbie team knows first hand that there is no one size fits all for feeding. With Bobbie, we hope you can Bottle Boldly. The Role We are looking for an exceptional Chief Financial Officer to join our executive team and drive the financial strategy of our rapidly scaling business. We are at an inflection point in our growth, and his role will be instrumental in supporting our growth across retail, DTC, and manufacturing channels while maintaining operational excellence and financial discipline. You are a strategic business partner who can navigate the complexities of owned manufacturing operations and help tell our compelling growth story to investors and stakeholders. You've helped build brands and know what it means to lead through step-level change moments. What you'll own:Financial Strategy That Drives Growth • Work hand-in-hand with our CEO and cross-functional teams to build financial plans that fuel our growth ambitions, • Maintain healthy, fully-loaded contribution margins as the business scales across retail, DTC, and manufacturing channels, • Deliver financial reporting and forecasting that gives everyone the insights they need to make smart decisions, • Build budgets that balance big growth bets (new manufacturing capacity, clinical trials, channel expansion) with the discipline to optimize costs, • Manage our cash flow so we always have the runway to fund our next chapterCapital Strategy & Allocation, • Lead capital raising initiatives through debt, equity, or other instruments to fund expansion, acquisitions, and new product development, • Analyze different financing options and determine the optimal capital structure to support growth objectives, • Evaluate and execute strategic acquisitions that align with the company's growth strategy, • Develop and maintain relationships with investors, lenders, and financial partners, • Act as the executive lead on financial transactions and capital events, including investor storytelling, board updates, and partnership with investment bankersFinancial Planning That Powers Decisions, • Create and manage sophisticated financial models for short and long-term business planning, including forecasting sales, expenses, and cash flow, • Conduct financial modeling, forecasting, and scenario planning to stress-test growth assumptions and identify risks and opportunities, • Provide robust data-driven insights to inform strategic decisions around growth initiatives, • Establish KPIs and metrics that drive accountability across the organizationExecutive Partnership & Strategic Leadership, • Be a trusted strategic partner to our CEO, executive team, and Board, • Communicate the company's growth story effectively to investors, analysts, and the market, • Collaborate closely with cross-functional leaders to align financial strategy with overall business objectives, • Participate in strategic planning and business development initiatives, • Lead beyond the Finance function, flexing into operational and organization areas as needed to help the business scale smartly, • Bring strong change management leadership, with experience navigating rapid scale or business transformationBuild a World-Class Finance Team, • Build and lead a finance team that's as passionate about our mission as they are about the numbers, • Create a culture where people own their work, keep learning, and innovate on how we do finance, • Put in place the systems, processes, and controls that let us scale without breakingManufacturing & Supply Chain Finance, • Understand and optimize the financial dynamics of owned manufacturing, including COGS, overhead allocation, and cost-saving opportunities, • Manage inventory, working capital, and operational efficiency within manufacturing operations, • Establish comprehensive risk management strategies to identify, monitor, and mitigate financial, operational, and compliance risks, • Drive cost optimization initiatives across the supply chainWhat we're looking for:, • Strong experience at the enterprise level in growth-stage environments, • Track record of active Board involvement and partnership with investment bankers and external stakeholders, • Ability to operate in ambiguity and take on cross-functional responsibilities outside of traditional Finance scope, • Combination of large-company training and growth stage consumer brands, • MBA, CPA, or equivalent advanced degree in Finance, Accounting, or related field, • 20+ years of progressive finance leadership experience, with at least 5 years in a CFO or senior finance executive role, • Proven track record in scaling consumer products businesses, preferably with manufacturing operations, • Demonstrated experience raising capital (debt and equity) and managing investor relations, • Experience building and leading high-performing finance teams in growth environments, • Proficiency with advanced financial planning tools, ERP systems, and business intelligence platforms, • Exceptional written and verbal communication skills with ability to present to boards and investorsNice to Have:, • Deep understanding of manufacturing cost accounting, inventory management, and supply chain finance, • Knowledge of FDA regulations or other relevant regulatory frameworks, • Experience with public company financial reporting and compliance, • Be Radical - We are change makers, rule breakers and stigma shakers. We are unapologetically bold and use our megaphone for good., • Nurture the Tension - Parenthood is full of healthy tension, and so is building a company. We embrace the unknowns, practice humility and are a culture of learners., • Deliver Ounce by Ounce - Our customers have entrusted us to feed their babies. We lose sleep over the details, so they don't have to., • Competitive stock options, • 401k with employer match, • Employee medical, dental, and vision insurance 100% covered by Bobbie, with options to add dependents through a subsidized pre-tax deduction, • US-based remote work model, • Flexible Time Off Policy (including Summer Fridays; half days on Fridays Memorial Day through Labor Day), • 16 paid company holidays, plus an end of year holiday shut down, • 16 weeks of paid parental leave with the option to take an additional 8 months unpaid, • One year subscription to Bobbie or Baby's Only, • $75 monthly internet stipend Bobbie is an equal opportunity employer. We do not make hiring or employment decisions on the basis of race, religion, color, national origin, gender, gender identity, sexual orientation, age, marital status, veteran status, disability status or genetic information, in compliance with applicable federal, state and local law. Bobbie Personnel Privacy Policy and Notice at Collection

Job Description Hi, we're Nuts.com! Nuts.com is a self-funded, profitable, rapidly growing multi-channel DTC specialty food and wellness company with over 550 people on our team. We're changing the landscape of snacking on nuts, dried fruit, chocolate and more! We planted our roots in Newark, New Jersey during the Great Depression, selling premium nuts on Mulberry Street's open-air market. We've come quite a long way since then, taking our multi-generational family business online in 1999. Even after 96 years, we continue to pride ourselves in expertly sourcing the highest quality foods and treating our customers like family. What's our team like? We're driven, collaborative and entrepreneurial. Energy and passion power our business and we look for candidates who share in that excitement to help us continue to build something special. The role: The Food Safety & Regulatory Compliance Specialist in the food industry is responsible for policy creation and implementation of the programs for food safety, and to ensure compliance of regulatory standards and 3rd party certifications. This position reports to the Food Safety Compliance Manager. The ideal candidate would be responsible for day-to-day and onsite activities related to supporting documentation for vendor approval, product specifications, and interacting with stakeholders seeking support from the food safety department and ensuring the company complies with all regulatory requirements. Stakeholders include external parties such as vendors, customers, regulators, and certifying agencies, as well as internal teams such as merchants, buyers, sales, copy writers, and operations teams. What you'll do: • Ensuring that all aspects of the food supply chain, from sourcing to production to distribution, comply with these regulations (e.g. FDA, USDA, SQF, CFIA)., • Overseeing Kosher, Organic, Certified Gluten Free, Prop 65 and BSE/Non-GMO compliance, • Reviewing and approving labels and packaging proofs for accuracy and compliance to claims., • Conducting research on regulatory and legal government policies., • Advising management on decisions impacted by regulations., • Preparing briefs, reports, and other documents for several audiences., • Support product documentation for currently sold products, new products, and for onboarding new vendors, • Periodic review and update of specification documents to ensure all claims are accurate including certifications, nutritional facts panel, allergens, and ingredients., • Manage requests for new vendors and new products, • Support Supplier Management Program through document review and approvals., • Developing and maintaining Standard Operating Procedures (SOPs) for food safety and quality., • Staying up-to-date on relevant food safety regulations and standards (e.g., FDA, USDA, SQF)., • Working with various departments, including production, quality control, and management, to ensure compliance and quality., • Collaborating with regulatory agencies and external auditors., • Ensuring accurate documentation of production and quality processes., • Assists with internal audits, verifying and documenting any quality and/or food safety issues, • Bachelor's degree in food science, food technology or related discipline preferred, • 2-5 years of relevant experience within the Food Quality/Safety/Regulatory space (food manufacturing highly preferred), • Experience with audit compliance and related audit requirements, • Experience with Organic, Gluten-Free, Kosher, Non-GMO verified programs high preferred, • Relevant certifications (e.g., HACCP, SQF) are a plus., • Competency with Electronic Quality Management Systems (EQCMS) along with excellent organizational skills, • Self-motivated, proactive thinking, • Strong knowledge of food safety regulations and standards., • Excellent organizational and documentation skills., • Ability to work independently and as part of a team., • Strong analytical and problem-solving skills., • A high-growth and rewarding role in a foundationally strong and rapidly evolving business, • Annual Salary Range: $60,000 - $80,000 plus annual bonus, • Excellent benefits including a 401K Match, • Paid Maternity, Adoption and Paternity leave, • And all the Nuts.com snacks your heart desires + a 40% employee discount EEO STATEMENT Nuts.com is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, immigration status, age, sex or gender (including pregnancy), gender identity or expression (including transgender status), sexual orientation, marital status, veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws. Applicants with disabilities who require assistance or accommodation during the application or interview process should reach out to us at

Job Description Client: Mondelez International Job ID: MDLZJP00003867 Title: Tester/Quality Assurance Location: Whippany NJ 07981 Duration: 03 Months 09/29/2025 to 12/31/2025 Work Hours 7-5 pm, Monday to Friday Description: • WGIC - Quality Assurance Technician Job description for the Food industry, • A Quality Assurance (QA) Technician in the food industry is responsible for ensuring that food products meet established safety, quality, and regulatory standards. This role is vital for maintaining product consistency, preventing contamination, and protecting consumer health. Key Responsibilities: • Testing and Inspection: Conducting routine and specialized tests on raw materials and finished products. They also perform inspections of production areas to verify sanitation and adherence to good manufacturing practices (GMPs)., • Documentation and Record Keeping: Maintaining accurate and detailed records of test results, inspection findings, corrective actions, and other relevant information for audits, traceability, and regulatory compliance., • Compliance Monitoring: Ensuring that all production activities adhere to established food safety regulations, including those set by the FDA and USDA, and implementing HACCP plans when necessary. They also monitor adherence to other food safety programs like GMPs., • Equipment Operation and Calibration: Operating and calibrating laboratory equipment and testing devices to ensure accurate and reliable results. Skills and Qualifications: • Collaboration: Work closely with production staff, quality control team, and other relevant departments to ensure consistent quality and food safety., • Attention to Detail: Must be highly detail-oriented to accurately assess products and document findings., • Problem-Solving Skills: Able to identify potential problems, analyze their causes, and develop solutions., • Communication Skills: Effective communication is crucial for conveying information about quality issues and corrective actions., • Knowledge of Food Safety Standards: A solid understanding of food safety principles and regulations (like HACCP) is essential., • Technical Skills: Basic computer skills, including proficiency in Excel, Word, and Microsoft Outlook, are often required., • Physical Abilities: The job may involve standing for extended periods, working in different temperature environments, and lifting objects (depending on the specific role and product).

Job Description About Care Access Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit . How This Role Makes a Difference The Clinical Research Assistant for the Future of Medicine program is an entry-level clinical position designed to fully integrate individuals into the Care Access research process. The Future of Medicine program brings clinical trials directly into communities, making research more accessible and inclusive for diverse populations. As a Clinical Research Assistant for Future of Medicine, you'll bring your skills wherever the research happens whether that is in local clinics, at community events, and occasionally at regional events (with travel up to 25%). This role offers opportunities for growth and advancement within the Care Access Research organization. How You'll Make An Impact • As a Clinical Research Assistant, you'll support every stage of the research process: engaging with participants and collecting biospecimens, to managing data and maintaining regulatory compliance. You'll help bring clinical trials directly into local communities by supporting recruitment, outreach, and event operations. Along the way, you'll gain hands-on experience in clinical research with opportunities to grow your skills and career., • Clinical & Participant Care, • Perform independent venipuncture, including managing difficult draws and re-attempts per protocol., • Collect, label, process, package, and ship biospecimens while maintaining chain of custody and temperature controls., • Obtain informed consent under the direction of the Clinical Research Coordinator (CRC)., • Complete protocol-required visit procedures under CRC direction., • Communicate clearly with participants and on-site teams; escalate issues promptly., • Maintain effective, professional relationships with participants, investigators, and sponsor representatives., • Study Operations & Data Management, • Record and enter data in real time on paper or e-source documents, ensuring accuracy and legibility., • Request and manage medical records for potential and current participants., • Update study trackers, online recruitment systems, and site logs., • Request and issue study participant payments., • Maintain adherence to FDA regulations, ICH guidelines, and institutional SOPs., • Member Education & Community Engagement, • Participate in member education and pre-screening events, which may occur at multiple locations., • Set up and tear down event sites; prepare kits and supplies, ensuring aseptic technique and biohazard safety., • Assist with distribution of outreach and education materials., • Schedule participant visits and provide reminders., • Clinical Site & Administrative Support, • Assist with administrative tasks such as copying, scanning, filing, mailing, and emailing., • Support inventory management and ordering of equipment and supplies., • Contribute to maintaining an organized, compliant site environment., • Other Responsibilities, • Communicate clearly in both verbal and written form., • Perform other duties as assigned in support of study success. The Expertise Required, • Technical & Operational Proficiency, • Comfortable using eSource/mobile apps and standard office tools., • Proficiency in Microsoft Office Suite., • Ability to learn and adapt in a fast-paced, evolving environment., • Strong organizational skills with close attention to detail., • Professional & Interpersonal Skills, • Excellent verbal and written communication skills with a high degree of professionalism across diverse groups., • Friendly, outgoing personality with the ability to maintain a positive attitude under pressure., • Critical thinker and problem solver with strong initiative., • Ability and willingness to work independently with minimal supervision while contributing effectively to team and site goals., • High level of self-motivation, energy, and an optimistic "can do" attitude. Certifications/Licenses, Education, and Experience:, • Clinical Skills & Experience, • 1+ year of recent, hands-on phlebotomy experience in a clinical setting (≥200 venipunctures; ≥25–50 capillary sticks; ≥30–50 in the last 2–3 months)., • Demonstrated competency in specimen processing., • Working knowledge of medical and research terminology, ICH-GCP, HIPAA/PHI handling, and related federal regulations., • Some prior clinical research experience preferred., • Current national phlebotomy certification, such as:, • ASCP Phlebotomy Technician (PBT), • AMT Registered Phlebotomy Technician (RPT), • NHA Certified Phlebotomy Technician (CPT), • NCCT National Certified Phlebotomy Technician (NCPT), • State-specific licensure/certification if required (CA, WA, LA, NV). How We Work Together, • Location: This position is for a full-time, hourly role. The standard schedule is Tuesday through Saturday, averaging 32–42 hours per week. Work is typically split between community events and a local clinical site (for example, a Houston-based team member may spend three days at community events and two days at the local site), • Travel: As a Clinical Research Assistant for Future of Medicine, you'll bring your skills wherever the research happens whether that is in local clinics, at community events, and occasionally at national events (with travel up to 25%). Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to:

Job Description Responsibilities • Develop and maintain food safety and QA programs per FDA and ISO standards., • Conduct quality audits to ensure regulatory and internal compliance., • Use measurement tools (e.g., micrometers, CMMs) to evaluate product quality., • Analyze QA data to identify trends and lead HACCP plan execution., • Train staff and collaborate across teams to resolve issues and drive continuous improvement. Qualifications • Comprehensive knowledge of FDA regulations, ISO 9001, ISO 13485, and HACCP., • Proficient with micrometers and coordinate measuring machines., • Experienced in QA/QC and conducting quality audits., • Skilled in analyzing complex data for decision-making., • Calypso software experience is a plus., • Strong leadership and team management skills., • Effective communicator and team collaborator.

Job Description The following is intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required. Job Summary: The Regulatory Affairs Specialist is responsible for supporting Regulatory activities which lead to, and maintain, regulatory compliance and approval for TriMed products globally. Supervisory Responsibilities: None. Duties/Responsibilities: • Perform gap analyses between new/revised regulations and standards and the TriMed Quality Management System (QMS)., • Review and assess published literature, preclinical data, clinical investigation results, field performance data and other relevant post-market surveillance data in order to evaluate device safety and performance., • Compile Clinical Evaluation Plans and Reports., • Assess reportability of changes to: labeling, design, materials, manufacturing process, sterilization or packaging., • Working with other departments, gather data for completing Post-Market Surveillance Reports, Periodic Safety Update Reports, Critical Analysis Reports, Summary of Safety and Performance Reports, etc., • Compile needed post-market reports., • Facilitate the completion of actions identified as a result of post-market reports., • Compile necessary documentation for the creation of technical files. Maintain technical files., • Assist with writing submission documents for regulatory agencies (FDA, Health Canada, etc.) and Notified Bodies., • Develop responses to questions or deficiency letters from regulatory agencies and notified bodies., • Use technical/clinical writing skills to clearly describe technical information for third party reviewers., • Perform submissions using the regulatory agency’s electronic submission process, if applicable (ESG, EUDAMED, etc.)., • Maintain registrations, certifications, and/or licenses, as applicable., • Assist new product development teams to provide regulatory support to the project, • Develop positive working relationships with other departments., • Actively participate in third party audits of TriMed. Required Skills/Abilities: • Experience with US and international regulations, and regulatory submissions preferred., • Experience in writing/maintaining CE Technical Files preferred, • Experience in international medical device licensing preferred, • Excellent written and verbal communication skills, analytical skills and sound interpersonal skills, • Strong attention to detail and pride in accuracy, • Excellent proficiency in Microsoft Office (Word, Excel, Outlook, Power point), • Exceptional organizing and prioritizing skills, • Ability to manage and track progress of project deliverables in order to meet deadlines and budgets, • Ability to influence people and functions, • A team player with positive can-do attitude, • A self-motivated and energetic person with an ability to work well under pressure Education and Experience: • Bachelor’s degree preferred., • Two years of medical device, pharmaceutical, or other FDA-regulated industry experience required. Physical Requirements: • Ability and initiative to work in the following environments: ambiguous, fast paced, hands-on, and deadline dictated, • This position works in an open office environment or position can be performed remotely., • While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk and sit. TriMed, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.

Job Description Job Description Date Written: Jul 29, 2025 Job Title: Chief Scientific and Impact Officer Location: Remote Department: Research & Development Reports to: CEO Wage Category: Exempt About CTF The Children’s Tumor Foundation (CTF) is not a traditional research foundation. We operate as a patient-centered drug discovery engine for NF, a group of genetic conditions that cause tumors to grow on nerves affecting 1 in 2,000 individuals. We operate by accelerating the full continuum of scientific discovery, from basic research through translation to clinical trials and approved treatments — while empowering patients and building the financial infrastructure to support that journey. We catalyze progress by uniting academia, industry, regulators, and patient advocates around shared goals. General Summary The Chief Scientific & Impact Officer (CSIO) reports to the CEO and is a strategic partner of the Executive Leadership Team. The CSIO will lead CTF’s research portfolio and drive partnerships that convert scientific breakthroughs into real-world therapies. TThe CSIO will manage a multidisciplinary team covering basic science, translational development, clinical strategy, and therapeutic scouting. The ideal candidate will not only understand science but will also bring a business development mindset to scientific innovation. The CSIO will identify opportunities, de-risking assets, and build collaborations that scale our impact. This role sits at the intersection of R&D strategy, translational execution, stakeholder alignment, and market-savvy decision-making. The CSIO will help steer CTF’s research pipeline and its financial pipeline including philanthropic funding to venture partnerships and commercial exits. Principal Duties and Responsibilities Strategic & Scientific Leadership * Lead the design and execution of an integrated research strategy spanning basic science, translation, clinical trials, and therapeutic repurposing or repositioning. * Oversee and coach a high-performing team of direct reports leading core scientific domains. * Serve as a thought partner to the CEO and Board on scientific and translational investment decisions. Business Development & Strategic Partnerships * Proactively identify, evaluate, and pursue high-impact partnership opportunities with biotech, pharma, CROs, investors, and academic institutions. * Support due diligence and asset triage, including shelved, preclinical, and early-stage therapeutic candidates. * Develop and structure public-private collaborations and co-funding mechanisms to drive therapeutic progress and leverage CTF capital. * In conjunction with the CEO build sustainable financial models for future CTF initiatives, including venture philanthropy, risk-sharing agreements, and translational consortia. * Build and oversee the financial budget for research, preclinical and clinical development, and key scientific activities. Stakeholder Engagement & Ecosystem Building * Act as a trusted convener across the research ecosystem including but not limited to regulators and researchers to investors and advocates. * Represent CTF in platform trials, biomarker programs, and international R&D alliances. * Maintain CTF’s neutral, non-conflicted role as an honest broker and trusted partner. Communication of Impact * Translate complex scientific programs into clear, outcomes-driven narratives for funders, partners, policymakers, and patients. * Demonstrate and quantify the return on CTF’s research investments — in terms of both patient outcomes and leveraged funding. * Represent CTF and its programs to medical and regulatory communities and pharmaceutical and biotechnology industry collaborators and partners, i.e. conferences, etc. Minimum Qualifications * Advanced degree (MD, PhD, or equivalent) in a biomedical field. * Significant leadership experience in biomedical R&D, ideally with exposure to both academic and industry environments. * Demonstrated experience in business development, licensing, strategic partnerships, or venture/scientific investment in rare diseases, oncology, or translational science. * Proven ability to work across scientific, financial, and operational domains to deliver outcomes. * Strong people leader with a track record of managing diverse, high-impact teams. * Deep understanding of the therapeutic development lifecycle, including biomarker discovery, regulatory interaction, and commercialization pathways. * Comfort navigating ambiguity and balancing scientific rigor with entrepreneurial agility. * Highly collaborative and diplomatic, with exceptional communication skills and executive presence. * Passion for patient-centered innovation and mission-driven work. * Strategic and innovative thinker with proven ability to communicate a vision and drive results. * Ability to communicate complex scientific concepts to diverse audiences, including policymakers, patients, and donors. * Demonstrated ability to secure and manage research funding. * Leadership experience, including managing teams and cross-sector collaborations. * Deep commitment to rare disease research and patient advocacy. * Experience working with the FDA, NIH, and regulatory agencies on rare disease policies and funding is a plus. Responsible for setting objectives and priorities for the Medical Advisory Boards in collaboration with the CTF Europe CSO and CTF CEO. * Lead efforts to secure research funding, including NIH, FDA, and philanthropic grants. .WORKING CONDITIONS, EQUIPMENT USED AND SPECIAL INFORMATION The CSO must have unimpeachable integrity and trustworthiness, while possessing a high degree of tact, discretion and professionalism. Maintain effectiveness under pressure. Flexible for moderate overnight business travel which may include weekends. DISCLAIMER The above statements are intended to describe the general nature and level of work being performed by the person assigned to this position. They are not intended to be considered an exhaustive list of all responsibilities, duties and skills required. Equal Employment Opportunity CTF and ADP provide equal employment opportunities to all employees and applicants in all Foundation facilities without regard to race, color, religious creed, sex, national origin, ancestry, citizenship status, pregnancy, childbirth, (or related medical conditions, including, but not limited to lactation), physical disability, mental and intellectual disability, age, military status or status as a Vietnam-era or special disabled veteran, marital status, registered domestic partner or civil union status, gender (including sex stereotyping and gender identity or expression), medical condition (including, but not limited to, cancer-related or HIV/AIDS-related), genetic information, or sexual orientation under applicable federal, state and local laws. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Job Description BGB Group Group Copy Supervisor Our Agency BGB Group is a healthcare communications agency that offers a wide range of services, including traditional pharmaceutical advertising, promotional medical education, payer marketing, and consulting services. Known for excellence and professionalism, we're hired as strategic and creative partners by our biopharmaceutical clients to drive category/brand awareness and growth. Position Overview As a Group Copy Supervisor, you will lead the development of compelling, strategy-driven content for healthcare brands across multiple therapeutic areas. You will oversee a team of writers, ensuring the highest standards of medical accuracy, creativity, and compliance with regulatory guidelines. In collaboration with cross-functional teams, you will help drive brand messaging, maintain consistency, and mentor junior and mid-level writers. This role requires both hands-on writing expertise and strong leadership skills. Role Requirements: • Lead the development of scientific and promotional content, ensuring alignment with brand strategy and compliance requirements., • Oversee and mentor a team of copywriters, providing guidance, feedback, and career development support., • Partner with creative, medical, and account teams to develop compelling, high-quality content across multiple channels (digital, print, video, social, etc.)., • Review and edit content for scientific accuracy, clarity, engagement, and adherence to brand voice., • Stay up-to-date with industry trends, regulatory guidelines, and competitive landscape to inform strategic content development., • Present content to internal teams and clients, articulating rationale and addressing feedback., • Manage workload and workflow to ensure timely delivery of high-quality materials., • Bachelor's or advanced degree in Life Sciences, English, Journalism, Communications, or a related field., • 6+ years of experience in healthcare/pharmaceutical copywriting, with at least 2 years in a supervisory role., • Strong understanding of medical and scientific concepts, as well as experience translating complex information into compelling content., • Familiarity with regulatory requirements (e.g., FDA, OPDP, medical/legal review processes)., • Exceptional writing, editing, and communication skills., • Ability to multitask, manage multiple projects, and work effectively in a fast-paced agency environment., • Experience working across a variety of therapeutic areas is preferred. The salary range provided is for the NYC-hybrid position, which requires occasional in-office presence, and represents what a potential hire may expect to earn in this role at BGB. For candidates in other locations, salary will be adjusted to reflect local market rates. Actual salary decisions will be influenced by several factors that we use to determine overall fit, including experience (both direct and indirect), education, training, demonstrated qualifications, and organizational need. Salary is only one component of the total rewards package offered at BGB Group. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other legally protected basis, in accordance with applicable law.

Job DescriptionTitle: Quality Control FG Manager Reports to: Head of Quality Department: Quality Control Responsibilities: • Scheduling of QC Inspectors for Incoming Components Receiving; Raw Material Receiving Inspection, Manufacturing/Production areas, Warehouse FG auditing, Special Sample handling, Review of Inspection Records, including but not limited to: In-coming Inspection records; In-process Batch Records and related documentation., • Conduct non conformance, product complaints, out-of-specification investigation and provide corrective and preventive actions with follow-ups as related to QC activities., • Trains and supervises document review personnel; Incoming Inspection records, batch release personnel, issues certificates of conformance (COC), certificates of manufacture (COM), and certificates of analysis (COA) to customers on bulk and work-in-progress (WIP). Maintains accurate record of approved, quarantined, rejected products., • Ensure compliance to all SOPs and other regulatory requirements (e.g. FDA, EPA, OSHA, ISO 13485:2003)., • Maintain working knowledge of OTC Drug requirements for incoming materials and ingredients; components (primary and secondary); intermediates, bulk and FGs., • Reviews, Approve, Release, Quarantine or Reject per compliance inspection and testing such materials as: Incoming OTC and Cosmetic RMs; Incoming bulk and intermediates; Incoming Components; where applicable, to customer requirements., • Maintains a working knowledge of QC inspection requirements for components, raw materials, in-process/bulk and finished goods., • Ensures that review of in-process activities in Manufacturing/Production and Warehouse areas is conducted by QC inspectors for conformance to specifications; follow up on out-of-specifications including non conformances., • Participates in In-process Quality in-house and outside training program., • Conducts periodic analysis of In-process Inspection program for pre-weigh and bulk manufacture and makes recommendations., • Assist in interpreting and/or developing of customer specifications and requirements for approved formulas., • Assists in establishing production and assembly inspection information sheets and documentation as required., • Maintains and updates ERP System, maintains repository of batch records/documents, and other Mfg & Pdn/Assembly in-process Specifications (F/As)., • Reviews of batch records, fill cards, work sheets, and Inspection documentation for completeness and correctness., • Conduct non-conformance resolutions, complaint investigations, and associated corrective and preventative actions., • Reviews of QC Inspection reports daily for correctness and completeness., • Facilitates on site customer inspections, coordinating availability of product and communication of disposition to Quality and Inventory Control. Interfaces with customer distribution operations where needed., • Maintains awareness and compliance with safety regulations in performing job duties., • Ensure that finished goods, bulk, raw materials, components are maintained correctly in the warehouse and other holding areas., • Assist in the review and release of finished products, when applicable., • Perform supplier and vendor audits, as well as, Mock recall and internal audits., • Ensure compliance to Product Quality Review stipulations., • Perform the functions of Authorized Person (AP) for goods and materials., • Maintain working knowledge of QC Analytical testing including IR, pH, Refractive Index, Viscometer, Spectrophotometry, Vacuum tester, and other Instrumentation., • Maintain working knowledge of MIL-STD/ANSI/ASQ Sampling and Testing., • Maintain Standards, Range boards, and Retain Samples ProgramQualifications:, • Minimum of Bachelor degree (Life Sciences, Engineering, related profession)., • Five+ years industry or related experience in cosmetic, device, food, or pharma., • Previous inspecting, auditing or manufacturing experience - a plus., • Data analysis, specification development skills., • Computer literate and effective communication skills., • Medical, Dental, and Vision Insurance, • Life Insurance, • 401k match sdNBCK0IEX

Job Description Our client in Fairfield, NJ is looking for a Senior Product Release Engineer for a Full time position. Pay is $110-125k annually DOE Responsibilities: • Oversee all aspects of programs from concept definition through successful transfer to manufacturing, advocate for the customer and needs/requirements., • Provide leadership to cross-functional technical teams responsible for successful launch of multiple complex programs., • Responsible for overseeing the coordination and on-time/in-budget completion of all project tasks which may involve some or all of the following technologies: progressive stamping, insert molding, factory automation and other related tooling/processes., • Oversee the creation and distribution of project schedules. Ensure that project milestones and deadlines are met including assignment of responsibilities., • Facilitate design definition, design reviews, tooling kickoff, and project postmortem activities., • Understand and meet Regulatory (FDA) requirements and processes for development., • Advanced Product Quality Planning (APQP) including completion of related documentation, including but not limited to: DOE’s, FMEA’s, Process Flowcharts, Control Plans, Capability Studies and Gage R&R’s., • Bachelor’s degree in mechanical engineering or biomedical engineering., • Minimum of 10 years of medical device experience., • Experience in developing and implementing procedures, methods, and tools for the manufacture or design and testing of medical products., • Experience in contributing to technical and cross-functional teams in accomplishing projects with notable impact on company objectives.

Job Description Sub-Investigator Key Responsibilities: • Assist the Principal Investigator (PI) in overseeing and managing clinical trials conducted at the research site, ensuring adherence to the study protocol, Good Clinical Practice (GCP), ICH guidelines, and all applicable regulatory requirements., • Provide medical oversight and ensure the safety and well-being of study participants throughout the trial, under the supervision of the PI., • Perform delegated study-related duties as assigned by the PI, which may include comprehensive patient assessments, physical exams, medical histories, and eligibility screenings., • Review and interpret eligibility, laboratory results, ECGs, and other diagnostic tests as required by the protocol and under PI supervision., • Assist the PI in making medical decisions regarding participant care, adverse events, and protocol deviations., • Ensure accurate, complete, and timely collection and documentation of all study data., • Communicate effectively with the PI, study team, and, as delegated, with sponsors, Contract Research Organizations (CROs), Institutional Review Boards (IRBs), and regulatory authorities., • Assist with investigational product accountability, storage, and administration according to protocol., • Participate in site initiation visits, monitoring visits, audits, and inspections as required., • Maintain continuous medical education and stay current with advancements in clinical research and relevant therapeutic areas. Position Requirements: • Master’s degree in Nursing from an accredited program., • Current Nurse Practitioner certification (FNP, AGNP, or specialty certification) or Physician's Assistant (PA) certification and state licensure., • At least 3 years of experience in clinical research, either as a Sub-Investigator, research fellow, or similar role, with a strong understanding of clinical trial processes., • Demonstrated knowledge of ICH-GCP guidelines, FDA regulations, and other relevant ethical and regulatory requirements for clinical research., • Strong interpersonal and communication skills, with the ability to work effectively as part of a team., • Excellent clinical judgment and problem-solving abilities., • Meticulous attention to detail and strong organizational skills., • Ability to prioritize tasks and manage time efficiently., • Familiarity with clinical trial management systems (CTMS) and electronic data capture (EDC) systems is a plus., • Commitment to ethical conduct and patient safety. Location: This position requires NP travel to the location of the study/program participant/patient. Travel may be local or across state lines based on licensure to practice.

Job Description Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn. Principal Biostatistician: Roles and Responsibilities • Can create randomization and kit schedules independently, collaborate with sponsor, randomization and drug supply management teams., • Can develop SAPs and iSAPs text and shells with no supervision., • Can review or develop ADAM specifications; can work with programmers and junior statisticians to resolve comments., • High technical level, Subject Matter Expert in biostatistics; willing to guide others in a variety of biostatistical techniques., • Has the ability to apply drug development knowledge during production of complex statistical analyses., • Can perform sample size calculations for a variety of scenarios and study designs. Can provide statistical consulting support to sponsors re study design and sample size calculations., • Leads complex projects, programs and submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsor., • Is familiar with and stays current with the latest industry practices and updated regulatory guidelines., • Understands the various tools that we work with and able to use them correctly (for SCM: checks in/out; use of external SharePoint)., • Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician., • Has high level knowledge of drug development as it pertains to biostatistics., • Produces and presents external company presentations providing industry visibility for the organization; Continually suggesting solutions to solve issues in tune with organizational direction., • Write blogs and/or white papers for posting on the company website, • Review or create the statistical section(s) of a Sponsor’s protocol and ensure that the appropriate statistical methods are proposed for the study design and objectives. Provide valuable feedback to the Sponsor on the statistical aspects of the study., • High proficiency with MS Office applications, • Demonstrate an understanding of project management-related tasks such as timelines, scope and resource requirement estimation/management., • Masters in Biostatistics, Statistics discipline or related field, or related experience, PhD preferred., • Minimum of 7 years’ experience in Biostatistics, Statistics or similar field required., • Submission experience (ISS/ISE), • Expert knowledge of scientific principles and concepts., • Reputation as emerging leader in field with sustained performance and accomplishment., • Proficiency with MS Office applications., • Hands-on experience with clinical trial and pharmaceutical development preferred., • Good communication skills and willingness to work with others to clearly understand needs and solve problems., • Excellent problem-solving skills., • Good organizational and communication skills., • Familiarity with current ISO 9001 and ISO 27001 standards preferred., • Familiarity with 21 CFR Part 11, FDA, and GCP requirements. jUtnt8qhwh

Job DescriptionQuality Assurance Compliance SpecialistAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. This position will report into the Associate Manager of Quality Compliance. Responsible to perform Quality Assurance Compliance activities in support of Quality Systems and/or client procedures, including but not limited to, document. management: investigations, CAPA, SOPs, qualification and validation reports, QC data. Supports Quality management with various department, organizational and operational excellence initiatives. Generally, exercises independent judgment, within generally defined practices and policies, when selecting methods and techniques for obtaining solutions. This role supports internal and external audits which may include interaction with Health Authorities and clients. • Liaises with relevant functional groups (Operations, Facilitates, QC, EH&S) to provide guidance through all stages of the investigation / CAPA processes., • Develops and communicates investigation strategy to key stakeholders., • In order to close investigation and CAPA, collect necessary information from appropriate department to close in quality system and maintain investigation and CAPA log, • Reviews and approves investigations and CAPAs;, • Conducts weekly status update meetings with cross functional departments and other stakeholders., • Monitors DR/CAPA KPIs including reporting requirements, provide detailed updates and information in support of quality & business review to management on periodic basis., • Prepares and issues change control as necessary., • Adherences and champions to all compliance regulations as required by regulatory agencies and per the Company’s processes and procedures., • Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations., • Conducts trend analysis of compliance related metrics such as deviations and CAPAs., • Performs supplemental investigations and/or participates in project teams or assignment as necessary., • Support in agency, internal and/or client audits., • Functional/Technical Skills: has the functional and technical knowledge and skills to do the job at a high level of accomplishment., • Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions., • Drive for Results: Can be counted on to exceed goals successfully; is constantly and consistently one of the top performers; very bottom-line oriented; steadfastly pushes self and others for results., • Written Communication: Able to write clearly and succinctly in a variety of communication settings and styles., • Peer Relationships: Quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers.REQUIREMENTS, • BS biological sciences or other relevant field of study., • 5 years’ + experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (Investigation report, CAPA report, SOPs etc.) required., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Familiar with FDA, ISO, and other regulatory agency guidelines., • Understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) required., • Working knowledge and technical understanding of aseptic manufacture of biologics preferred., • Experience in both clinical and commercial manufacturing is preferred., • Experience in supporting health authority inspections and/or client audits preferred., • Minimum Required Training (optional); GXP training, SOP & WI training, Safety Training, • Understanding and comprehension of quality system applications.Working Environment Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit.Must be able to work in a team-oriented environment.Must be able to work occasional weekends, nights, and/or holidays as required/necessary.May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids.Must be able to handle the standard moderate noise of the manufacturing facility.Must be able to work in open floor plan environment and may work in close proximity to others.Wheel-o-Vator available for use.Small breakroom available. No on-site cafeteria available.Able to utilize equipment in manufacturing are as well QC laboratories.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionLead Our 2nd-Shift Packaging Floor Step into a high-impact leadership role on our 2nd shift, where you’ll guide a large team on a fast-paced pharmaceutical packaging floor. Every evening, you’ll coordinate line start-ups, keep production flowing, and ensure our work meets the highest standards of safety, quality, and compliance. A Day in This Role As the 2nd-shift supervisor, you’ll arrive as the afternoon transitions into evening. You’ll confirm packaging components are staged, validate line readiness, and brief 150–300 team members. Throughout the shift, you’ll partner closely with QA to resolve quality concerns, oversee line changeovers, monitor adherence to cGMP, and make real-time decisions that protect throughput and compliance. At close, you’ll finalize batch records with QA, verify line clearance, and reconcile any excess components before handing off a clean, ready operation. What You’ll Do • Lead, coach, and train 150–300 packaging line employees to achieve production goals., • Uphold cGMP and all regulatory requirements, including FDA, OSHA, and DEA guidelines., • Direct line start-ups, break schedules, and end-of-shift procedures to optimize uptime., • Review and approve packaging orders; confirm components are checked and approved for use., • Train new and existing staff on SOPs, proper equipment use, and packaging requirements before job start., • Oversee component staging so materials are in place before production begins., • Partner with QA to resolve quality issues and support the site safety program., • Maintain clean, well-maintained lines, machines, and tooling at all times., • Complete batch records with QA, ensure line clearance, and reconcile excess components at lot close., • Conduct performance reviews and provide clear feedback to direct reports. What You Bring, • Bachelor’s degree preferred; or 5+ years of relevant industry experience., • 3–5 years of supervisory experience in pharmaceutical packaging operations., • Hands-on knowledge of packaging equipment: check weighers, fillers, labelers, cappers, and metal detectors., • Bilingual English–Spanish strongly preferred., • Ability to lift at least 45 lbs and work in a noisy packaging environment. Why You’ll Love Working Here, • Competitive salary and comprehensive benefits., • Clear pathways for advancement in a growing organization., • Collaborative, team-first culture., • Access to cutting-edge technologies in the pharmaceutical industry. Proficiencies We Value, • Leadership / People Management, • Continuous Improvement, • Language: Spanish, • FDA Regulations, • Pharmaceuticals, • Standard Operating Procedures (SOPs), • Supervisory Experience, • Packaging Experience, • Experience in a Manufacturing Environment Machines & Technologies You’ll Use

Job Description PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech®, it’s about more than just a job—it’s about your career and your future. Your Role We are excited to accept applications for future opportunities. Join our talent pool for future openings by applying now. This is a W2-Temp 6-month role with potential FTE extension. We are hiring experienced validation engineers responsible for the commissioning, qualification, and validation for facilities, utilities, and equipment in the pharmaceutical and biotech industries. Our engineers play a critical role in driving project success, while supporting validation planning, development, documentation, and execution, and ensuring regulatory standards and quality requirements are met. • Develop and execute commissioning, qualification, and validation protocols for required equipment and systems., • Prepare and maintain comprehensive documentation, including validation protocols, plans, reports, and standard operating procedures., • Identify and assess risks associated with CQV activities and develop effective mitigation strategies., • Troubleshoot and resolve issues related to equipment and process performance., • Collaborative with cross-functional teams to ensure alignment on CQV activities and project timelines., • Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP, etc.)., • Additional responsibilities as required to drive successful validation project deliverables. Requirements • Bachelor’s degree in Engineering, Life Sciences, or a related field., • 5+ years of equipment commissioning, qualification, and validation engineering experience in the pharmaceutical and/or biotech industries., • Strong knowledge of regulatory requirements and industry standards., • Experience with validation lifecycle management and risk-based approaches., • Excellent analytical and technical problem solving skills., • Strong technical writing skills and understanding of full lifecycle documentation (protocols, reports, procedures, risk assessments, specifications and requirements, etc.), • Effective communication and interpersonal skills., • Proactive with strong organization, time management, and project management abilities., • Excellent attention to detail with commitment to quality and compliance., • At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally. Equal Opportunity Employment Statement PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law. #LI-RW1 Benefits W2 Temp positions include our medical and sick time benefits. Adhering to the requirements of New Jersey's law on salary transparency, the salary bracket for this role is set between $100,000 - $115,000 annually. The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . Description: The Senior Process Engineer or Process Engineer II will support and lead manufacturing process development and optimization for our medical device products. This position plays a key role in ensuring that all manufacturing processes meet quality, compliance, and performance standards. The engineer will work closely with cross-functional teams including Quality, R&D, Regulatory, and Production developing, optimizing, and scaling manufacturing processes to improve yield, throughput, quality, and efficiency. The Process Engineer will have a strong operational, quality, and technical background. This is often a hands-on role working closely with the production team to train operators to new processes, troubleshoot equipment challenges, and write and execute qualifications and validations. This is a full-time, on-site position, located in Brooklyn, New York. It is a multi-faceted role in a highly collaborative environment that will require creativity and focused execution in pursuit of maximizing production outputs and creating robust manufacturing processes. Responsibilities: · Design, develop, and optimize manufacturing processes for new and existing medical devices. · Lead process development for new product introductions (NPI), from concept through validation and launch. · Develop and refine manufacturing processes to reduce variation, increase yield, improve cycle times, and reduce cost. · Evaluate and implement automation technologies to improve process consistency and throughput. · Interface with external vendors and suppliers to specify new equipment, product or process requirements, or troubleshoot product issues. · Analyze production data to identify trends, root causes, and opportunities for efficiency. · Maintain and update validation documentation as part of lifecycle management. · Ensure processes comply with applicable regulatory requirements and internal quality standards. · Lead root cause investigations (CAPA, NCRs, SCARs) and implement corrective and preventive actions. · Develop process documentation including standard operating procedures (SOPs), work instructions, pFMEAs, and equipment qualifications. · Partner with R&D during design transfer to ensure design for manufacturability (DFM) and seamless product integration. · Collaborate with Quality and Regulatory teams to support audits, inspections, and compliance initiatives. · Provide technical leadership and mentorship to junior engineers and technicians (for Senior level). · Monitor and analyze key process indicators (KPIs), quality metrics, and manufacturing data · Specify, procure, and validate manufacturing equipment and tooling. · Author and execute process validation protocols (IQ/OQ/PQ) in accordance with FDA and ISO 13485 standards. · Train manufacturing personnel on new or revised processes and equipment. · Provide ongoing floor support for manufacturing operations, helping to resolve technical issues in real time. · Other duties may be assigned as deemed necessary by management Requirements · Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related field. · Process Engineer II: 5+ years of experience in a regulated manufacturing environment with 3+ years process development, design, and process implementation required. · Senior Process Engineer: 10+ years of experience in a regulated manufacturing environment with at least 5 years hands-on experience in process development, design, and process implementation required, preferably in medical device, pharmaceutical, or biotech manufacturing. · Understanding of FDA 21 CFR Part 820, ISO 13485, and GMP requirements. · Proven experience with process validation (IQ/OQ/PQ), root cause analysis, and CAPA. · Proven experience in process design, optimization, and troubleshooting. · Experience implementing process and quality improvements into manufacturing or CMO · Strong analytical and problem-solving skills. · Ability to multitask and prioritize work, while remaining detail-oriented. · Demonstrated experience training technical personnel. · Familiarity with data analysis tools and manufacturing software. · Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. · Experience with Lean Manufacturing, Six Sigma, or similar methodologies. · Hands-on experience with manufacturing processes such as formulation, fill and finish, packaging, and CIP. · Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency in a timely manner. · Demonstrated experience managing third-party vendors and service providers. · Demonstrated ability to work independently as well as be a strong team contributor. · Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks. · Excellent verbal and written communication skills required. · Ability to become gowning qualified to work in a cleanroom environment. · Ability to speak, listen, and understand verbal and written communication in English. · Ability to lift 30 pounds of force occasionally and to lift, carry, push, pull, or otherwise move objects. · Strong computer skills, with proficiency in the use of Microsoft Excel, Microsoft Word, Microsoft PowerPoint. · Legal authorization to work in the United States. Preferred Qualifications: · Master’s degree in Engineering or related field. · Experience in medical device or pharmaceutical · 3+ years of relevant cGMP manufacturing experience. · Experience in cleanroom operations, including aseptic processing. · Experience with CMOs. · Significant experience with CAD software · Experience in supporting regulatory inspections and audit readiness. · Six Sigma certification (Green or Black Belt) or Lean Manufacturing experience. · Mechanical/Electrical knowledge with the ability to troubleshoot equipment · Strong leadership skills with the ability to influence and motivate a cross-functional team · Organizational and time management skills with the ability to prioritize a variety of tasks/projects. · Demonstrated understanding of aseptic processing and microbial control concepts. Benefits Competitive annual base salary range of $90,000 - $150,000, depending upon job level and qualifications. · Paid Vacation, Sick, & Holidays · Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage · Company Paid Life and Short-Term Disability Coverage · Work/Life Employee Assistance Program · 401(k) & Roth Retirement Savings Plan with company match up to 5% · Monthly MetroCard Reimbursement Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . Description: The R&D Engineer I/II is responsible for supporting product design and process development activities while ensuring compliance with all quality and regulatory requirements. The position has a scientific focus that includes implementation of formulation development through process development, prototype fabrication, and characterization, along with additional process evaluation and data generation through designed experiments. Process development in an R&D environment will be followed by qualification and technology transfer into manufacturing. Collaboration is a key aspect of this role, as the engineer will work within a multidisciplinary team of researchers and engineers. The position offers diverse opportunities in a collaborative cross-functional environment, requiring adaptability, flexibility, and a willingness to learn and innovate in the exploration of new technologies, new approaches, and techniques in pursuit of product/process robustness and innovation. The R&D Engineer I/II is expected to possess expertise in areas including, but not restricted to, polymer, chemical, material science, and process development and engineering. Additionally, they will assist in generating documentation essential for regulatory submissions, ongoing publication initiatives, and direct communication with the Head of Research regarding various tasks. This is a full-time, on-site position, located in Brooklyn, New York. This role is an independent contributor role (i.e. no direct reports). Level is dependent on experience. Responsibilities: • Oversee the planning, implementation, and analysis of experiments relevant to project objectives. Ensure the application of established scientific and engineering principles to solve complex problems and challenges innovatively and efficiently, adhering to rigorous scientific methodologies and protocols., • Create and execute product/process enhancement, and new product/process development plans., • Lead material/design/process changes and their implementation with well-documented research/analyses. Process and analyze results,, • Author protocols and reports including engineering studies and design verification/validation activities., • Aid in the development and execution of testing methods to aid in exploratory research, product/process development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes., • Prepare samples as required for manufacturing, testing, or other evaluations and data analysis., • Participate in voice-of-customer (VOC) labs and other user needs assessments., • Interface with external vendors, customers, and suppliers. Specify equipment and process requirements for developing and implementing new products, product improvement and new equipment/processes., • Support process and product transfers to manufacturing or CDMOs., • Maintain a laboratory notebook and other technical documentation according to required GLP/GMP guidelines., • Understand and prioritize process improvements, design experiments to make those improvements, and execute these plans in the laboratory., • Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation about research towards FDA/regulated authority submissions., • Provide support to the marketing and sales team, with the development of presentations, sales tools, and application data., • Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization. Required Qualifications • Education: BS in Chemical Engineering, Polymer Engineering, Material Science & Engineering, or related engineering discipline., • Minimum 4+ years previous experience in an industrial environment with a BS degree. (2 years minimum experience if advanced degrees)., • Proficiency as an adept experimentalist with hands-on experience in the process development of polymeric materials and their characterization in an R&D or manufacturing environment., • Mathematically inclined with strong analytical and problem-solving skills with the ability to be observant and to think creatively. Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies. Demonstrated ability to work independently as well as be a strong team contributor. Ability to effectively work within a team and cross-functionally to expedite the completion of critical project tasks., • Requires understanding of product/process design and engineering. Experience should include process development/validation and/or transfer/verification, protocols, and troubleshooting skills., • Ability to handle multiple project assignments of medium scope and complexity and able to prioritize and complete work with a sense of urgency on time., • Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills., • Working knowledge of Good Documentation Practices (GDP) and Good Manufacturing Practices (cGMP) requirements., • Proficiency in the use of Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft PowerPoint is required., • Requires excellent written and verbal communication and presentation skills., • Legal authorization to work in the United States is required., • Physical Requirements include:, • Aseptic Gowning Qualification: Able to be successfully qualified for aseptic gowning, including successful respirator training., • Wear Appropriate Personal Protective Equipment (PPE):, • Be able to stand and walk for prolonged periods, with the ability to climb, balance, stoop, bend, reach, and handle equipment., • Ability to speak, listen, and understand verbal and written communication., • Possesses hand-eye coordination and manual dexterity for delicate manipulations., • Ability to lift up to 50 pounds occasionally and to carry, push, pull, or otherwise move objects., • Visual acuity is required for performing close and distant activities. Preferred Qualifications • An advanced technical degree (MS or PhD)., • ·Lab experience in an industry setting within cGMP-regulated environments., • Prior experience developing processes and scaling these up into manufacturing or CDMO, • Mechanical/electrical knowledge with the ability to troubleshoot processing equipment, • Six Sigma green belt or black belt certification preferred., • Experience implementing process and quality improvements in a manufacturing environment, • Work experience with the medical device or pharmaceutical industries, • Working knowledge of ISO 9001, ISO 13485:2003 and ISO 14971:200., • Working knowledge of FDA requirements as per 21 CFR 820. Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits • Competitive annual base salary range of $70,000 - $120,000, depending upon job level and qualifications, • Paid Vacation, Sick, & Holidays, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%, • Work/Life Employee Assistance Program, • Company Paid Life and Short-Term Disability Coverage, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

Job DescriptionAbout CookUnity Food has lost its soul to modern convenience. And with it, has lost the power to nourish, inspire, and connect us. So in 2018, CookUnity was founded as the first-of-its-kind platform that connects the world with the source of truly great food: chefs. Today, CookUnity delivers 50 million meals a year from the industry's best chefs to homes all over the country. Fresh. Ready-to-eat. And crafted with the passion that nourishes body and soul. Unwilling to stop there, CookUnity is expanding beyond delivery to become an ever-innovating marketplace focused on our singular mission: empower Chefs to nourish the world. If that mission has you hungry in more ways than one, you've found the right job posting. About the Team: Our Food Safety & Quality Assurance (FSQA) and Operations teams are dedicated to upholding the highest standards of cleanliness and safety across CookUnity's facilities. The Sanitation Manager will be an integral part of this effort, working hands-on with hourly teams on the ground to ensure compliance, accountability, and excellence every day. The role: We seek a proactive and detail-oriented Sanitation Manager to lead sanitation operations at our New York facility. This is a full-time, on-site position responsible for managing a large hourly workforce (80+ direct reports) across multiple shifts. The Sanitation Manager will ensure food safety, cleanliness, and compliance with regulatory requirements while fostering a culture of accountability, teamwork, and continuous improvement. The Sanitation Manager will manage the daily tasks performance of our dish and cleaning teams. This role requires flexibility to be present on-site during weekdays, weekends, and occasionally night/overnight shifts, depending on operational needs. Responsibilities: • Oversee and lead all personnel devoted to sanitation activities, ensuring adherence to master sanitation schedules, SSOPs, GMPs, and HACCP., • Serve as the primary operational contact for 3rd-party cleaning services and manage vendor relationships including chemical provider and linen service., • Collaborate with FSQA to enhance program and procedures, taking the lead on implementation., • Manage Sanitation staffing, schedules, time keeping and performance evaluations, • Monitor and enforce compliance with regulatory standards for cleanliness, hygiene, and safety across all production areas and equipment., • Lead on implementation of sanitation corrective actions assigned through audits, pest deficiency reports, inspections or program improvements., • Collaborate with FSQA and Operations teams to maintain and improve food safety and quality standards., • Collaborate with maintenance to coordinate deep cleans, emergency clean ups and sanitation preventive maintenance., • Manage chemical usage, storage and safety in accordance with OSHA and manufacturer guidelines., • Provide sanitary expertise on operation, cleaning and light maintenance of dish washing machines, floor scrubbing machines and other equipment., • Maintain accurate records of sanitation procedures and cleaning logs, • Ensure compliance with applicable regulations and company-specific food safety protocolsQualifications:, • 3 - 5 years of Sanitation leadership experience in a food processing environment, • Bilingual in English and Spanish., • Strong knowledge of food processing sanitation standards in FDA/USDA regulated facilities, and knowledge of GMP, SSOP & HACCP, • Proven leadership and team management skills., • Must be available to work weekends, nights, and across multiple shifts as required by facility operations., • Positive, driven, solution-oriented mindset., • Ability to work independently and manage multiple priorities in a fast-paced environment, • Excellent communication, problem-solving, and organizational abilities., • Comfortable working in wet, cold/hot, and potentially noisy conditions for extended periods., • Flexibility to manage personnel as needed across three shifts, including overnights and weekends Learn More About CookUnity We believe great leadership starts with alignment on vision, values, and ways of working. To give you deeper insight into who we are and what we're looking for, we invite you to explore: CookUnity's Leadership Principles – The values and behaviors that guide how we operate, collaborate, and scale. We hope this provides valuable insight into our culture and product vision. If this excites you, we'd love to connect! Benefits 🩺 Health Insurance coverage 🌅 401k Plan 📈 We grow, you grow: Stock Options Plan granted on Day 1 🌟 Eligible for a bi-annual performance bonus ⛱ PTO policy and paid sick days 🗓️ 5- year Sabbatical: After 5 years with CookUnity, you get a 4-week paid sabbatical 🐣 Paid Family leave 🕯 Compassionate Leave: 3-5 days each time the need arises 🥘 A generous amount of CookUnity credits to enjoy our amazing meals, added to your account, monthly 🧘🏽️‍♀️ Wellness perks: access to a nutritional coach and fitness subsidies to build a healthy lifestyle 👩🏾️‍🏫 Personalized Spanish coach 🌟 Awesome opportunity to join a company that is looking to change how we eat and how chefs work! #ENG1P Compensation All final pay rates will be determined by candidates experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data.Pay Range for this position$90,000—$110,000 USD If you're interested in this role, please submit your application and if we think you might be a fit, we'll get in touch with you. Thank you for your time! CookUnity is an Equal Opportunity Employer. We are dedicated to creating a community of inclusion and an environment free from discrimination or harassment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, citizenship status, protected veteran status, genetic information, or physical or mental disability.

Job DescriptionTitle: Quality Assurance (QA) Supervisor Reports to: Quality Manager or Head of Quality Department: Quality Assurance Responsibilities: • Oversee Quality Systems Modules for compliance (Change Controls, Deviations, Discrepant Materials, Returns, Supplier Issues, etc., • Support Investigations (e.g. non conformance, product complaints, out-of-specification investigation and provide corrective and preventive actions with follow-ups)., • Train and supervise document control/review personnel; batch release personnel, accurate record of approved, quarantined, rejected products., • Lead the review, release and compliance of materials, FG, bulk and intermediates where applicable, to support customer requirements., • Support audits, inspections and ensure compliance to all SOPs and other regulatory requirements (e.g. FDA, HC, EPA, OSHA, ISO 13485:2016)., • Familiar with US FDA OTC drug regulations, including data integrity requirements., • Maintains a working knowledge of QA inspection requirements for components, raw materials, in-process/bulk and finished goods., • Ensures that review of in-process activities in both Manufacturing and Warehouse areas is conducted by QA inspectors for conformance to specifications; follow up on out-of-specifications including non conformances., • Participates in In-process Quality in-house and outside training program., • Conducts periodic analysis of In-process Inspection program for pre-weigh and bulk manufacture and makes recommendations., • Assist in interpreting and/or developing of customer specifications and requirements for approved formulas., • Assists in establishing production and assembly inspection information sheets and documentation as required., • Maintains and updates ERP System, maintains repository of batch records/documents, and other Mfg & Assembly in-process Specifications., • Reviews of batch records, work sheets, and Inspection documentation for completeness and correctness., • Support non-conformance resolutions, complaint investigations, and associated corrective and preventative actions., • Reviews of QA Inspection reports daily for correctness and completeness., • Facilitates on site customer inspections, coordinating availability of product and communication of disposition to Quality and Inventory Control. Interfaces with customer distribution operations where needed., • Maintains awareness and compliance with safety regulations in performing job duties., • Ensure that finished goods, bulk, raw materials, components are maintained correctly in the warehouse and other holding areas., • Assist in the review and release of bulk and finished products, when applicable., • Perform supplier and vendor audits, as well as, Mock recall and internal audits., • Support Process Validation and Cleaning & Sanitization Validation activities under the quality systems to ensure compliance., • Support formal drug stability program, bulk hold studies, and product compatibility by co-ordinating samples submission, testing, result retrieval and program review., • Maintains files and database of customer-approvals and documents as evidence of authenticity., • Effects changes to specification sheets as approved through proper change control requests., • Support Change Control Requests for Customer requested changes to raw material, intermediate/bulk, FGs, specifications., • Maintains copies of approved change controls as applicable to product specification updates/revisions., • Under the supervision of Quality Manager, review and approved formulas, specifications and procedures., • Communicates new and updated SOPs to all employees at EWL. Qualifications: • Minimum of associate degree or bachelor degree (Life Sciences, Engrg, related profession)., • Three + years industry or related experience in cosmetic, device, food, or pharma., • Experience/Knowledge of US FDA OTC regulations - a plus., • Previous inspecting, auditing or manufacturing experience - a plus., • Data analysis, specification development skills., • Computer literate and effective communication skills., • Ability to lift and carry up to 10-15 pounds.Compensation & Benefits:, • Pay range: $60,000 - $65,000 per year, • Medical, Dental, and Vision Insurance, • Life Insurance, • 401k match obtLtIxvhl

Job Description Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company’s proprietary hydrogel technology. The company’s plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for extended manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives. Learn more about the company at . The R&D Formulation Manager/Principal Scientist will lead the design, development, and implementation of novel formulations and polymer materials for use in medical devices, ensuring all activities meet quality and regulatory standards. This role involves providing expertise in formulation development, building and optimizing internal capabilities to deliver innovative and efficient solutions, and ensuring alignment with the company’s long-term technical vision to create a strong pipeline of customer-focused innovations. Key responsibilities include developing and characterizing formulations, recruiting and onboarding talent, managing technical collaborations with external suppliers and vendors, and integrating formulations into scalable manufacturing processes, whether in-house or through CDMOs. This role operates in a collaborative, cross-functional environment, requiring flexibility, a strong focus on scientific formulation, and a drive to explore new technologies and techniques in pursuit of robust, innovative materials and products. The R&D Formulation Manager/Principal Scientist is expected to be a subject matter expert in areas including polymer material science, formulation strategies, analytical chemistry, and biomaterial interactions with biological systems. They are responsible for ensuring high standards in research practices. They are responsible for leading the creation of documentation required for regulatory submissions, developing strategies for grants and publications, and securing non-dilutive funding through grant opportunities. They will report to the Vice President Technology. This is a full-time, on-site position, located in Brooklyn, New York Responsibilities • Lead, staff, and manage formulation development teams and their efforts across multiple parallel product development opportunities, to launch new commercially successful products., • Provide sound scientific leadership, monitoring and coaching through the initiation, planning and execution their team’s overall activities., • Create and lead experimentation for exploratory and/or product development research with focus on polymeric materials and their use., • Exercise technical judgment in the design, execution, and interpretation of experiments within the scope of project responsibilities and ensure the use of professional concepts to solve complex problems in creative and effective ways, in conformance with scientific methods and procedures., • Lead material/design/process changes through design control process, with well-documented research/analyses., • Review and author protocols and reports including development studies and design verification/validation activities., • Develop and implement investigations into new technologies and capabilities, partnering with business development, that advance research team and company objectives., • Lead efforts in chemical and mechanical property evaluation to assess the desirability of process or formulation changes. Develop test method capabilities to support R&D (exploratory research, product development) and production test requirements., • Develop unique, proprietary (and ideally patentable) intellectual property that yields competitive advantage., • Lead and participate in voice-of-customer (VOC) labs and influence go-to-market strategies., • Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication., • Work as part of a cross-functional team to develop, verify, and validate product designs through bench, in-vitro, and in-vivo testing and other assessments., • Ensure an effective documentation system is in place and utilized throughout the development process inclusive of R&D lab notebooks, design reviews, test methods, and test reports., • Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions,, • Act as research liaison between R&D and Quality Control to define product specifications., • Maintain active dialogue with Manufacturing to ensure successful technology transfer and process development, including the review of research-related documents, • Provide guidance and support to commercial teams, support introduction of new technologies with development of presentations, sales tools, formulations and applications data., • Communicate results to the scientific community via published papers. Present research at academic/industry symposia as an external representative of the company., • Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization. Required Qualifications • Master’s degree in Chemistry, Materials Science, Chemical Engineering, Polymer Science, or a closely equivalent discipline., • A minimum of 10 years of research experience in developing and utilizing polymeric materials, biomaterials, or other complex materials toward product/application development and their manufacture., • A minimum of 2 years of direct management experience., • Adept experimentalist with hands-on research experience with polymers, coagulation chemistry, and materials science of complex systems, including the development of structure-property performance relationships in designing and characterizing these materials., • Demonstrated ability to solve difficult technical problems and deliver practical solutions that meet the application requirements, along with a fundamental understanding of the chemistry that drives the performance required. This includes strong analytical, problem-solving, and decision-making skills with the ability to be observant and to think creatively., • Direct experience in new product development from concept to regulatory approval through launch., • Demonstrated ability to design experiments and analyze data with the use of appropriate quality and statistical methodologies is required., • Excellent verbal and written communication skills, with the ability to lead in a dynamic and collaborative environment is required., • Highly organized and detail-oriented, with the ability to extract key facts from complex information and create/present clear and concise technical documentation is required., • Demonstrated ability to lead and inspire teams and develop and mentor individuals, and allocate resources strategically and according to the portfolio priorities., • Requires strong leadership and organizational skills with a strong attention to detail and multi-tasking skills while simultaneously keeping overall “big picture” view of projects, priorities, and strategies., • Experience working under pressure with tight timelines, with the ability to maintain a sense of priorities, focus, urgency, and delivery., • Strong working knowledge of Microsoft Office., • Legal authorization to work in the United States. Preferred Qualifications • Ph.D. in a relevant discipline is strongly preferred., • Experience developing and commercializing products in a highly regulated environment, • Medical device development experience., • Demonstrated expertise in the use, development, and qualificication of material characterization techniques, including rheological, thermal, mechanical, spectroscopic, microscopic, and other chemical compositional methods., • Strong understanding of medical device regulatory requirements for Class II and III medical devices (e.g., 21 CFR Part 820), cGLP/cGMP, and related standards (e.g., ISO 13485)., • Strong understanding of cGMP, ICH guidelines, • Six sigma green belt or black belt certification., • Experience with executing a grant and publication submission strategy, knowledge of and strong track record with SBIR submissions to multiple agencies, including NIH and DOD is strongly preferred., • Demonstrated experience in Project Management and Product Lifecycle Management practices, and the ability to lead multiple projects simultaneously., • Excellent problem-solving skills and a proactive approach to addressing formulation challenges. Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time. Benefits BENEFITS • Competitive annual base salary range of $130,000 - $180,000, depending upon qualifications., • Paid Vacation, Sick, & Holidays, • Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage, • Company Paid Life and Short-Term Disability Coverage, • Work/Life Employee Assistance Program, • Monthly MetroCard Reimbursement, • 401(k) & Roth Retirement Savings Plan with company match up to 5%

Job DescriptionSr. Manager Quality Assurance Validation Computerization Systems The incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • Bachelor’s Degree in a Scientific or Engineering discipline, • 8 + years of computerized system experience with IT compliance/validation/qualification activities., • 8 + years of experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • 10% travel required., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements., • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments., • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements., • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications., • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports., • Coordinate implementation validation/qualification strategies and serve as the subject matter expert., • Present project status reports to management as well as project teams., • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes., • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements., • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report., • Support internal, client, and regulatory audits and inspections., • Generate or review/update computer system related policies, procedures, templates, forms, etc., • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures., • Performs other quality system related duties as necessary.REQUIREMENTS, • BA/BS Degree in a Scientific or Engineering discipline, • 8 + years experience computerized system experience with IT compliance/validation/qualification activities., • 8 + years experience working in an FDA-regulated, GxP-related environment., • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance., • Comprehensive knowledge in Software Validation and Data Integrity Principles., • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations., • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models., • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems., • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ)., • Knowledge of Software Risk Management Principles and tools., • Knowledge and proven ability working with Risk Management methodologies and tools., • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus., • Experience with application system validation and infrastructure qualification., • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus., • Experience with writing and approving Standard Operating Procedures and Quality Standards., • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint)., • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams., • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers., • Solid organizational and time management skills, proven project management, presentation and facilitation skills., • Innovation and strategic compliance skills including looking internally and externally for best practices., • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems., • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities., • The ability to enable and drive change while being focused on internal and external customers., • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise., • 10% travel required.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionThis position will report into the Manager of QC Analytical. The QC Analytical Supervisor will organize, and direct staff to meet and exceed cGMP requirements, and establish KPI’s, while adhering to quality control and technical standards. The QC Analytical Supervisor will also provide oversight of day to day activities including adjustment of workflow, test performance, and quality compliance. • Ensures compliance with regulatory agency requirements by enforcing a quality culture throughout the department., • Schedules and monitors daily operation of department based on projected client demands., • Conducts routine walkthroughs of the facility to ensure compliance with regulatory and quality practices., • Approval of investigations and documentation of non-confirming events and OOS., • Recommends process improvements to achieve greater efficiency within the department and between sites., • Participates in department and cross functional meetings., • Maintains audit readiness within the department by ensuring proper training of staff, reviewing documentation, and ensuring laboratory cleanliness., • Interacts with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns., • Direct reports: QC Analysts (Approximately 8-10 reports), • Other duties as assigned.REQUIREMENTS, • BS degree in Science or relevant field;, • 7+ years of experience with analytical laboratory or within the biopharmaceutical industry or equivalent., • Strong knowledge of FDA and EU regulatory standards. cGMP experience required., • Strong knowledge of analytical test methods and philosophies., • Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review., • Proficient with computer software with MS Office and LIMS, • Competencies/Candidate Profile, • Acts decisively, • Exercises good judgment and makes effective, sound, timely and informed decisions. Seeks to identify, analyze and resolve problems effectively., • Builds and maintains relationships, • Strong collaborative and influencing skills and ability to work well in a matrixed environment with internal and external stakeholders., • Communicates effectively, • Uses appropriate modes and media, targeting the amount, level of detail, and content of the information to the needs of the audience. Prepares clear, concise, and well-organized written documents and oral presentations. Conveys information clearly, confidently, and with the proper tone. Facilitates open communication. Uses discretion and demonstrates sensitivity to confidentiality concerns. Listens effectively and provides appropriate feedback., • Fosters continuous improvement and innovation, • Promotes efforts aimed at improving current business processes through a culture that fosters continuous improvement and innovation. Identifies and implements improvements and innovations that increase efficiency and enhance work quality. Promotes ongoing development of staff and takes initiative to assess and self-develop supervisory competencies., • Fosters integrity and honesty, • Displays and fosters integrity and honesty through the promotion of mutual trust and respect, demonstrates and fosters high ethical standards, and treats others fairly and ethically., • Supervises and manages performance, • Builds and manages a multi-sector workforce based on organizational goals, budget considerations, and staffing needs. Ensures staff are recruited and selected using merit principles. Ensures tasks are appropriately delegated and completed by monitoring performance against predetermined standards and requirements and holding staff accountable for meeting expectations. Trains and develops staff, provides constructive performance feedback and appraisals, and takes appropriate corrective action to address performance and conduct issues., • Manages projects and functions, • Manages projects and leads initiatives in the workplace. Organizes resources, people, and activities; and ensures collaboration and the achievement of project and function goals and targets. Ensures effectiveness and efficiency in the delivery of services, products and/or programs., • Determines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees., • Provides oversight and direction to the employees in accordance with the organization's policies and procedures., • Coaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities., • Empowers employees to take responsibility for their jobs and goals. Delegates responsibility and holds staff accountable by providing regular feedback., • Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise., • Creates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization., • Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning., • Appropriately communicates organization information through department meetings, one-on-one meetings, appropriate email, and regular interpersonal communication., • GxP/GDP TrainingWorking EnvironmentWhile performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. Must have the ability to work with specialized equipment.The employee must be able to comply with the company's personal hygiene standards as they apply to aseptic processing. The employee must successfully complete sterile gowning training/qualification as well as annual re-qualification as a core competency requirement of their employment in this role. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.