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Job DescriptionJob Title: Bakery Production ManagerLocation: Brooklyn, NY Department: Operations Reports To: Owner Employment Type: Full-Time Schedule: Monday–Friday, 7:00 AM to 5:00 PM, with some evenings/nights and on-call availability Salary Range: $100,000 – $120,000 per year Bonus Eligible: Yes Environment: Non-Union, Industrial Bakery Co-Manufacturing Facility Team Size: 5 direct reports and 70+ indirect reportsCompany OverviewWe are a commercial industrial co-manufacturing bakery based in Brooklyn, NY, specializing in high-quality bread, pastries, and specialty baked goods. Operating with a lean team of 75, we prioritize operational excellence, food safety, and customer satisfaction across every batch we produce.Position SummaryWe are seeking a hands-on, experienced Bakery Production Manager to lead all production operations at our facility. This is a critical leadership role responsible for managing daily production, enforcing compliance with food safety protocols, mentoring staff, and driving performance metrics through continuous improvement and strong team leadership.Candidates must have at least 6 years of commercial bakery experience and a minimum of 3 years in a supervisory or management role within food manufacturing.Key Responsibilities • Oversee and manage daily bakery production schedules to meet throughput and quality targets., • Lead, mentor, and develop a team of 35+ employees including supervisors, table leads, and operators., • Enforce compliance with all GMP, HACCP, OSHA, FDA, and food safety protocols., • Minimize downtime and increase production yields by identifying and implementing process improvements., • Collaborate cross-functionally with QA, Maintenance, Logistics, and other departments to ensure smooth operations., • Maintain and audit accurate documentation for compliance, traceability, and reporting., • Provide hands-on leadership on the production floor with a focus on safety, quality, and efficiency., • Support SQF food safety practices and act as the SQF backup practitioner when QA leadership is unavailable., • Utilize bakery production systems including SAP, PRIMS, E-Maintenance, and Safety Chain., • Train staff in the proper use of bakery equipment such as mixers (Hobart/Pearless), proofers, ovens, Konig, Rheon, Unifiller, Handtmann, flow wrappers, and inkjet coders., • Monitor labor costs, control overtime, and maintain alignment with production budgets., • Ensure cleanliness, proper line changeovers, and adherence to SSOPs., • Serve as a primary point of escalation for any production-related issues.Required Qualifications, • Minimum 6 years’ experience in a commercial bakery environment (industrial scale required)., • Minimum 3 years’ supervisory/management experience in food manufacturing., • Strong working knowledge of bakery equipment and processes., • High school diploma or GED required., • HACCP, OSHA, and Food Safety certifications preferred., • Proficient with Microsoft Office (Excel, Word, Outlook) and able to adapt to proprietary systems., • Detail-oriented with excellent leadership, communication, and time management skills.Top 3 Must-Have Competencies, • Deep knowledge of industrial bakery operations and ability to operate and troubleshoot related equipment., • Strong leadership and team development skills with the ability to motivate and hold teams accountable., • Extreme attention to quality, safety, and performance metrics in a fast-paced environment.Tools, Equipment & Systems You’ll Use, • Systems: SAP, PRIMS, E-Maintenance, Safety Chain, Excel, • Equipment: Hobart & Pearless mixers, ovens, proofers, Konig, Rheon, Handtmann, Unifiller, Pita Divider, X-ray/metal inspection systems, flow wrappers, inkjet coders, palletizing systemsBenefits, • 401(k) Retirement Plan, • Medical, Dental, and Vision Insurance, • Paid Time Off (PTO), • Maternity & Paternity Leave, • Commuter BenefitsHiring Timeline, • Start Date: Immediate, • Urgency: High, • Interview Process: 3 in-person rounds with the Owner, HR, and COOThis is a high-impact leadership opportunity for a motivated bakery professional who thrives in fast-paced environments and is passionate about people, quality, and operational excellence. If you meet the qualifications and are ready to take your career to the next level, we want to hear from you.

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 35 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. The role: While believing that healthy food fuels stronger communities, we are looking for an energetic and innovative Food Safety Manager - Supplier Auditor within our Food Safety and Quality Assurance (FSQA) team. The supplier auditor will oversee CookUnity's (CU) extensive Food Safety and Product Quality audits throughout various food industry suppliers; retail, food service, and direct growers or processors/purveyors. Guarantee unwavering compliance with finished product quality standards among suppliers, following CookUnity's dedication to delivering premium meals. This position is vital in equipping chefs with superior ingredients to craft outstanding culinary experiences for our clientele. The supplier auditor will promote and contribute to specialized initiatives that enhance CU's supply chain program. Responsibilities: • Conduct Food Safety and Product Quality audits across various venues, including Food Service Operations, Manufacturing, and Food Distribution outlets., • Perform ongoing risk assessments, develop corrective actions, and monitor the implementation and effectiveness of preventive measures., • Develop and analyze supplier scorecards and reports to identify trends in distribution and co-manufacturing product complaints., • Create a comprehensive external audit program tailored to CU's operations, GFSI benchmarks and industry best practices., • Conduct regular audits across all CU markets as assigned. Clearly communicate audit findings to relevant stakeholders., • Organize and audit co-manufacturers' and distributors' quality assurance documentation. This includes reviewing annual GFSI audit reports, Open/Closed CARs, nutritional compliance, Certificates of Analysis (COAs), product specifications, allergen forms, and other product claims, as applicable., • Maintain accurate supplier information in the supply chain portal, including supplier contacts and associated product codes., • Collaborate with CookUnity Supplier teams, Chefs, internal FSQA teams, and the CX Teams to align supplier goals., • Communicate directly with CU supplier teams and Individual CU Markets regarding Chef feedback, initiating CARs as necessary to facilitate root cause investigations and resolutions., • Act as POC for all ingredient or product withdrawal / recall / traceability issues between supply source and place of manufacturing amongst CU facilities.Qualifications:, • Bachelor's degree in food science or Applied Science field., • At least three to five (3-5) years of work experience. A mixture of education and experience equivalent to the above may substitute., • Experience auditing various USDA & FDA regulated facilities., • Knowledge of HACCP, SSOP, GMP, GFSI schemes are essential., • Diverse backgrounds of food manufacturing and kitchen services is a plus., • Valid Driver's License with acceptable motorist history required., • HACCP certified., • Serve Safe Manager Certification is desired but not required., • SQF or BRC Certification is a plus.Preferred requirements:, • Must have excellent oral, written & presentation skills at a technical and general level., • Must be able to effectively communicate throughout all levels of the business., • Proficiency in Microsoft Office programs., • Preferred: Experience in culinary, food preparation, meat/protein processing, ready-to-eat foods, refrigerated foods, ready-to-heat foods., • Nice to have: Bi-lingual (Spanish) Benefits • 🩺 Health Insurance coverage, • ⛱ PTO policy and paid sick days, • 📈 We grow, you grow: Stock Options Plan granted on Day 1., • 🌟 Eligible for bi-annual performance bonus, • 🐣 Family leave: 12 weeks for primary caregiver and 4 weeks for secondary caregiver, fully paid, • 🕯 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! 🗓️ 5- year Sabbatical: After 5 years with CookUnity, you get a 4-week paid sabbatical 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$70,000—$84,000 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 DescriptionCompany Description We at IBA InfoTech find the Hidden Talent across the globe. We connect caliber candidates with leading companies in contract, contract-to-hire and direct-hire positions in various industries - Oil & Gas, Energy, Telecommunications, Transportation, Business & Finance, Retail, Hospitality and Insurance. Job Description Hiring: MES Engineer – PAS-X Senior Engineer Location: New York, NY / Raritan, NJ Interview: Phone/Skype Job Type: Contract We're seeking a talented engineer skilled in #PASX #MBRDevelopment #GxPCompliance to lead MBR/GMBR design, validation, and implementation on PAS-X V3. #PharmaJobs #MES #AutomationEngineering #GMP #FDACompliance #ProjectLeadership Additional Information All your information will be kept confidential according to EEO guidelines.

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 Medical Device Engineer is responsible for leading the design and development activities of new products and improving existing products in compliance with all quality and regulatory requirements. S/he will be responsible for authoring technical documents for the development of medical devices and combination products according to relevant Design Control regulations and standards. The person in this position will also be responsible for providing project-specific support, including technical analysis and review of supplier documentation as required. The position has a scientific focus that includes formulation development, product performance characterization, and implementation including proto-type design and fabrication and data generation through designed experiments. The Medical Device Engineer is expected to aspire for excellence with a bias toward action, willing to roll up their sleeves, get hands-on, and do what’s necessary to move projects forward in a fast-paced environment. They are committed to designing and developing products that dominate the marketplace and improve healthcare by partnering with our customers to drive purposeful innovation, resulting in best-in-class products. The Medical Device Engineer will work with a multidisciplinary team of researchers. This is a multi-faceted job in a highly collaborative environment across multiple functions that will require flexibility as well as an ability to learn about and develop new technologies and explore new techniques in pursuit of product innovation and robustness. Role level is contingent on experience, but this is not an entry level role.. This is a full-time, on-site position, located in Brooklyn, New York. Responsibilities • Create and lead experimentation for exploratory and/or product development research focusing on polymeric materials devices and their use., • Define new product functional requirements (design inputs/user needs) and evaluate the design's overall effectiveness, cost, reliability, and safety., • Lead cross-functional teams to develop new products, address design issues, and maintain existing designs., • Apply strong problem-solving skills to find solutions to complex problems., • Work independently to plan and schedule own activities necessary to meet project timelines., • Work cooperatively with, quality, manufacturing, regulatory, clinical, and marketing to ensure project success., • Lead the creation of design history file documentation through the new product development process., • Develop new implant and instrument designs utilizing Solidworks and modeling/detail design specifications., • Generate technical protocols/reports to support device safety and efficacy., • Invent/create concepts and designs and submit invention disclosures., • Ensure that all design activities adhere to FDA Quality System Regulations and ISO 13485 design control and risk management requirements. Lead material/design/process changes through a design control process, with well-documented research/analyses., • Author protocols and reports including development studies and design verification/validation activities., • Develop and execute test methods to aid in exploratory research, product development, and quality control; conduct chemical and mechanical property evaluation tests to assess the desirability of process or formulation changes., • 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., • Prepare samples as required for testing, or other evaluations and data analysis, including in voice-of-customer (VOC) labs., • Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication., • Maintain a laboratory notebook and other technical documentation to required GLP/GMP guidelines., • Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions,, • Provide support to marketing and sales team, support the introduction of new technologies with the 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., • Manage part-time staff as a research leader and mentor for ongoing research projects., • Work with company leadership to evaluate existing research practices and contribute to a culture of ethical, high-quality research operations within the organization., • Provide other project or product support as needed in order to support Cresilon’s business objective. Required Qualifications • BS in Chemical Engineering, Polymer Engineering, Material Science, Biomedical Engineering, Mechanical Engineering, or related scientific discipline., • A minimum of 4+ years of product development experience is required., • A minimum of 2 years of hands-on experience in new product research and development in a cGMP-regulated industry is required (work experience in the Medical Device field is strongly preferred), • Adept experimentalist with hands-on experience in product development of medical devices and their safety/efficacy characterization in an R&D environment., • Experience gathering user needs, translating them to technical inputs, and developing viable V&V (Design Verification and Validation) plans., • Experience leading complex product development initiatives from concept through release., • Good working knowledge of anatomy and surgical procedures is required., • Demonstrated ability to solve difficult technical problems and deliver practical solutions that meet the application requirements is required. This includes strong analytical, problem-solving, and decision-making skills with the ability to be observant and to think creatively., • Demonstrated ability to design experiments and analyze data with appropriate quality and statistical methodologies., • Demonstrated ability to work independently as well as effectively be a strong team contributor and work cross-functionally to expedite the completion of critical project tasks, • 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., • Ability to lead directly and by influence, including strong problem-solving, conflict resolution, and analytical skills., • Requires strong leadership skills, excellent written and verbal communication and presentation skills., • Working knowledge of FDA requirements as per 21 CFR 820, • Proficiency in the use of Microsoft Excel, Microsoft Word, and Microsoft PowerPoint is required., • Legal authorization to work in the United States is required. Preferred Qualifications • An advanced degree (MS or Ph.D.) is highly preferred., • Hands-on experience in product development with Class II and Class III medical devices., • Experience developing test methods and protocols/reports for safety and efficacy testing of implant and instrument designs., • Working knowledge of ISO 9001, ISO 13485:2003, and ISO 14971:2007., • Experience with IDE and PMA submissions., • Working knowledge of Good Documentation Practices (GDP), and Good Manufacturing Practices (cGMP), • Good understanding of statistical tools and validation/verification techniques., • Six-Sigma green belt or black belt certification 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 $80,000 - $160,000, 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 DescriptionSalary: $100,000 - $120,000 WHO WE ARE Were an entrepreneurial, fast-growing team of Project Managers, Estimators, Superintendents, Safety and Administrative Support personnel. As leaders in quality construction management, were committed to providing impeccable service to our clients, a safe work environment for our team, and an opportunity for our employees to grow and enjoy the benefits of work/life balance. Here at ALLY, we cultivate a collaborative environment that values tenacity, attention to detail, and comradery. Since outstanding customer service is our best product, we strive to build long-lasting relationships with our entire customer base. POSITION SUMMARY As an Estimator reporting to a Sr. Estimator or Vice President, your primary role is to provide analysis and pricing of construction projects by conducting construction estimating, budgeting and bidding for assigned projects ranging in value from $100K to $30M. You will interact with architects, clients, subcontractors, business development and operations staff to ensure a clear understanding of project objectives, schedules and other information. You will develop competitive bids as well as conceptual budgets in response to specific proposal requests. You will also solicit and maintain relationships with qualified subcontractors and material suppliers in order to receive responsive and competitive proposals and pricing. You will be expected to maintain a strong understanding of current and ongoing market conditions and be aware of any significant changes in the market, including pricing changes, lead time impacts, changes to the supplier base, etc. RESPONSIBILITIES * Provide thorough review of construction plans, architectural and engineered drawing sets. * Identify items that have been omitted and ensure appropriate accounting for such items in overall estimate package that represents the full scope of the project. * Timely preparation of conceptual estimates, competitive bids, budgets, and pricing analysis, as required on proposed projects. * Share information about reliable sub-contractors and suppliers to assist Project Managers and other team members in the timely preparation of GMP and Lump Sum pricing. • Schedule and conduct frequent project walkthroughs with subcontractors and clients to define scope of work and visually survey the project extents, • Prepare competitive Lump Sum and Time and Material bids on construction projects, including timely review of associated bid forms, pricing, and general conditions by appropriate senior management. Assist Project Managers with subcontractor/vendor bidding on projects. * Develop conceptual project schedules based on subcontract input and historical data. * Maintain a construction cost database, including historical cost data and unit pricing. * Maintain the subcontractor/vendor qualified bidders database for use by estimating and Project Managers along with other team members. * Identify and remain current with an up-to-date understanding of the latest construction materials, pricing, trends, systems, procedures, means and methods, computer programs, management techniques, code changes, etc.. * Follow approved estimating practices consistent with corporate guidelines and ensure such practices result in the most complete estimates possible while meeting financial objectives. * Ensure quality and timely work output by prioritizing tasks and meeting assigned deadlines. * Provide feedback to senior leadership on gaining competitive advantages over the competition. * Be proactive in identifying opportunities through current and past clients. * Attend client meetings to discuss estimates, answering any questions and resolving any issues regarding pricing and estimates throughout duration of project. * Provide change order pricing, site visits, bid delivery and collaboration with teams. * Prepare estimates used for management purposes such as planning, organizing, and scheduling work, preparing bids, selecting vendors or subcontractors and determining cost effectiveness. * Conduct special studies to develop and establish standard hour and related cost data for effect cost reductions. * Analyze completed projects to compare estimated costs to actual costs and determine the reason for any discrepancies. * Close out estimate packages and maintain archive files. * Regional travel up to 3 days at a time, throughout the Northeastern US, Mid-Atlantic and Southeastern US will occasionally be required. REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES (KSA) * Excellent estimating, communication, financial analysis, budgeting, purchasing, negotiation and computer skills are essential. * Requires expertise in the use of computer software programs, such as, Microsoft Office Suite. Blue Beam and Premier experience are a plus. * Life Sciences or manufacturing facility project experience (or similar) preferred. * Must have reliable transportation. * When driving on company business, a clean driving record, valid drivers license, properly maintained employee-owned vehicle with the state minimum mandated levels of auto liability insurance are required as a condition of employment. MINIMUM REQUIREMENTS * Possess ALLYs Core Values * Embrace Change (Adaptability). * Success is No Accident (Safety). * Go Above and Beyond (Client Services). * Empowering Success (Accountability). * Thriving Together (Team Culture). * 5-10 years of construction estimating experience. * Bachelors degree in Construction Engineering or Management or equivalent work experience is preferred. * Eligible to work in the United States. * Adherence to ALLYs employment and corporate policies. * Quality performance of duties listed in the job description. * Respectful interaction with other employees, owners, consultants, subcontractors, and the general public. * Must have reliable transportation and when driving on company business, a clean driving record, valid drivers license, properly maintained employee-owned vehicle with the state minimum mandated levels of auto liability insurance is required as a condition of employment. * Must be a team player. PHYSICAL DEMANDS / WORK ENVIRONMENT * While performing the duties of this job, the Estimator is required to sit for long periods of time and is occasionally required to stand; walking within a 400-acre campus; use hands to finger, handle or feel objects, reach with hands and arms; climb stairs and ladders; balance; stoop, kneel, crouch, or crawl; talk or hear; taste or smell. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. Estimators are required to speak clearly so listeners can understand and hear clearly to understand the speech of another person. In this role and employee may also occasionally lift and/or move up to 20 pounds. * Client site pending, work environments can involve some exposure to hazards or physical risks, which require following basic safety precautions. * Work may involve moderate exposure to unusual elements, such as extreme temperatures, dirt, dust, fumes, smoke, unpleasant odors, and/or loud noises. Interested in joining the ALLY team? Please email us your resume with cover letter and include the position youre applying for in the subject line to . ALLY CONSTRUCTION SERVICES IS AN EQUAL OPPORTUNITY EMPLOYERApplicants are considered regardless of race, color, religion, creed, age, sex, pregnancy, family responsibility, national origin or ancestry, citizenship, marital status, sexual orientation, transgender status, veterans status, genetic information, or status as a qualified individual with a disability or any other protected characteristic in accordance with applicable law.

Job DescriptionTitle: Regulatory Affairs Specialist Reports to: Manager of Regulatory Affairs Department: Quality/ Regulatory Responsibilities: • Assist the Manager of Regulatory Affairs during cGMP, Environmental, and Regulatory audits., • With the assistance of Head of R&D (or designee), create and collate product master files (dossiers), drug master files (DMF)., • Generate and Review of Product CoCs, CoAs, CoMs, BSE documents, CMR documents, RM Certificate of Analysis, Safety Data Sheet, technical documents, RM composition breakdown, as may be required for local and international submissions., • Generate Raw Material Regulatory statement: Origin Statement, Cruelty Free statement, Heavy metal statement, Impurity statement, Food allergen statement, Fragrance allergen statement, Nitrosamine-free Statement., • Review Customer “No-No List, Special Store Prohibited List, Prop 65, REACH-Compliant Statements, Global and regional Compliance statements, EU/China-compliant statement, etc. (as applicable)., • 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, ISO 13485:2003)., • Responsible for facility registrations, renewals, and document submissions to regulatory agencies (eg Drug and Cosmetic listings, etc), under the direct supervision of the Head of Quality/Regulatory., • Assist the Manager of Regulatory Affairs during periodic quality 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 21CFR 210, 211, and 820; and key elements of ISO 13485:2003., • Maintain familiarity with changing global regulatory requirements., • Minimum of Bachelor degree (Life Sciences, Engineering, related profession)., • Experience of drug, cosmetic, medical device regulatory process is a pre-requisite., • Familiarity with FDA requirements under 21CFR 210, 211, & 820 is a pre-requisite., • Two+ 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., • Pay range: $60,000 - $65,000 per year, • Medical, Dental, and Vision Insurance, • Life Insurance, • 401k match, • PTO Powered by JazzHR Bnx5PV2JZt

Job DescriptionThe 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 DescriptionCompliance Investigator, Clinical ManufacturingAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Compliance Investigator, Clinical Manufacturing leads life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventative actions to ensure compliance. • Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, field complaints and environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools., • Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track CAPA plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approach., • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process., • Champion CAPA plans and implementation., • Provide communication plan for on-going deviations & CAPA’s., • Effectively create and communicate CAPA plan to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • Ability to abide by quality standards.REQUIREMENTS, • BS degree in a Quality/ Process related field., • Experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology or Bio-Pharma., • Root cause analysis experience in pharmaceutical or FDA regulated operation preferred., • Experience using e-Quality Management Systems preferred., • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Flexible and able to adapt to company growth and evolving responsibilities, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • Ability to work effectively as a team and independently., • Quality Systems Training (Deviation/CAPA)Working Environment While 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. Non-absorbent laboratory coats are required, as well as latex (or a non-latex substitute) gloves. When working with potentially hazardous materials that may spray, aerosol, or otherwise contact skin or mucous membranes, face shields or goggles must be worn. Heavy cryo-gloves must be used when working with liquid nitrogen. 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 One of the nation’s largest independent testing facilities seeks an Analytical Chemist with a minimum 2 years' experience testing products for the pharmaceutical, nutritional cosmetic, personal care, medical device or allied industries. The position requires a working knowledge of testing products in a GMP regulated facility. Responsible for performing physical, chemical and instrumental techniques on APIs, raw materials and finished products according to schedule. Must have the technical ability to understand client requirements and assist in the preparation of testing protocols. • Run instrumentation such as, but not limited to: ICP-MS, HPLC, GC,UV, IR, AA, DSC, KF on products according to compendial, client and internal methodologies., • Prepare standards and samples for analysis., • Perform physical, chemical and instrumental techniques on APIs, raw materials and finished products., • Execute method transfer and validation protocols., • Document work clearly and accurately., • Perform technical writing and peer review as needed., • Operates and maintains laboratory equipment and instrumentation required for cGMP analysis of samples., • Bachelor's degree in chemistry or other related degree, preferred., • Minimum 2 years of product testing experience in a GMP laboratory., • ICP-MS/OES experience required., • Previous data acquisition software (Totalchrome, Empower, etc.) experience required., • Excellent scientific and organizational skills., • Strong communication skills (written and oral) with an attention to detail., • Ability to learn new techniques, multitask, follow instructions and comply with SOPs., • Self motivated and have the ability to work independently and as part of a team., • Ability to stand/sit in office and laboratory environment., • Ability to use a personal computer and Microsoft Office (Word, Excel, Outlook) experience required., • Vision accuracy and color detection are required for this position, • Ability to wear/use personal protective equipment as required such as lab coat, goggles, gloves, masks, etc., • Ability to lift up to 30 lbs.Company DescriptionConsumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.Consumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.

Job DescriptionManager Manufacturing OperationsAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Primary Processing Unit (PPU), Manager, Manufacturing Operations is responsible for efficient capacity utilization of site resources to meet customer demand. They will partner with support functions to deliver on customer demands. This leader is accountable for the management of client projects at the site and for delivery of results within project scope, agreed timelines, contract requirements, revenue targets, as well as compliance and regulatory requirements. The Manager, Manufacturing Operations is responsible for profit and loss within their PPU and will deliver on revenue. This role will also drive individual and team development to ensure a prepared and empowered workforce to become the provider of choice for the industry. • Meet client process demands through planning, scheduling, manufacture and delivery., • of clinical cell therapy products according to established procedures, regulations and contract., • Ensures manufacturing documentation is closed out in a timely manner in accordance with applicable regulations and per contract., • Ensures capacity availability of resources (room/equipment/staff) to perform clinical manufacture for clients per contract., • Ensures process hours are charged - tracked to meet contract and revenue targets., • Accountable for maintaining a mechanism to work with clients to troubleshoot problems, suggests improvements and determines & advocates for value-add projects., • Assures manufacturing space is kept in a clean, validated state in compliance with company procedures, GMP and applicable regulations, • Ensures on the job training program and resources for new associate (proficiency) training and cross training of existing staff., • Ensures a safe work environment for employees., • Ensures department staff compliance with corporate and site-specific HR policies, safety and business policies and practice., • Approves job specific curriculum for the training and professional development of department staff., • Holds regular staff and 1:1 meetings to emphasize corporate culture, maintain morale, and provides a forum for staff development and discussion., • Responsible for the profit and loss for the PPU, • Deliver on revenue, • Assures compliance with budget, • Liaison with support groups – supply chain, training, quality systems, and business development, • Partners with clients along with Project Management and team leadership; drives the account management and liaison with the clients, • Sets team expectations and goals and delivers the business direction for the PPU, • Sets KPIs & ROIs targets and assures PPU metrics are maintained and tracked monthly., • Coordinates with PPU leadership and team meetings and determines PPU strategy development, • Accountable for driving the spirit of continuous improvement, • Collaborates with Business Development to ensure compliance and contract requirements, • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Directly supervises the following roles: Associate Manager, Manufacturing, Manufacturing Associates, Lead Manufacturing Associates, Production Support Associates, Technical Trainers, Compliance InvestigatorsREQUIREMENTS, • Bachelor's degree (ie Biology, Biotechnology, Bioengineering, Chemical Engineering)., • 5-7 years of cGMP environment, aseptic processing, mammalian cell culture, cell processing, cryopreservation experience., • 5-7 years of leadership experience or equivalent combination of experience., • Strong business acumen, • Deep understanding of cGMP and cGLP, • Working knowledge of financial operations and budget development, • Relevant IT skills (Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Meeting management/facilitation skills/teamwork, • Ability to multi-task team is essential, • Flexible and able to adapt to company growth and evolving responsibilities, • Drive to create and maintain order in a fluid technically complex environment, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • List required training that must be completed by incumbent in order to fulfill the responsibilities for this role. Examples can include aseptic techniques, gowning qualifications, manager training, GMP, etc., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to work during the weekend, holidays and as required by the company, • May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen, • Must have the ability to work in the cleanroom environment for extended period of time, • Must have the ability to work with specialized equipment, • May work with hazardous materials and chemicals, • Environment requires gowning, hair net, safety glasses, gloves, and foot coverings.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 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 Bachelors in a technical or scientific field is required., • Minimum 6+ years’ experience in preclinical medical device research is required, preference given to veterinary 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 DescriptionTitle: Quality Control (Bulk) Supervisor Reports to: QC Manager (or Director of Quality) Department: Quality Control Lab Responsibilities: • Scheduling of QC bulk Analysts, Special Sample handling, Review of In-process Batch Records and related documentation., • Support / Conduct non-conformance, product complaints, out-of-specification investigation and provide corrective and preventive actions with follow-ups., • Train and supervise document review personnel; 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)., • Perform bulk releases and compliance of bulk and intermediates where applicable, to GMP and customer requirements., • Maintains a working knowledge of QC Batching and Preweigh inspection requirements for in-process/in-kettle and completed bulks., • Ensures that QC review of in-process activities in Batching and Preweigh and Warehouse areas is conducted 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 Batch cards, Preweigh cards for completeness and correctness., • Conduct non-conformance resolutions, complaint investigations, and associated corrective and preventative actions., • Reviews of QC Batching and Preweigh reports 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., • Minimum of GED, Diploma or degree (Life Sciences, Engineering, related profession)., • Three or more years of 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. The approximate pay range for this position is $65,000 - $75,000. Final compensation may vary based on factors including but not limited to knowledge, skills and abilities. The benefit package includes: • Medical, Dental, and Vision Insurance, • Life Insurance, • 401k match, • PTO Powered by JazzHR YZBfEHMhfn

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 DescriptionJob Title: Quality Control Laboratory Technician Job Description As a Quality Control Laboratory Technician, you will be responsible for using micrometers and calipers to measure incoming instruments and ensure they meet the required standards. You will review drawings and instruments to verify product accuracy, report on part conditions and non-conformances, and ensure custom OEM orders meet customer specifications. You will update QMS systems and paper documents as needed for audits, and utilize Good Manufacturing Practices (GMP) throughout all processes. Responsibilities • Receive and unpack incoming shipments; verify quantities and assess the condition of materials., • Perform inspections on raw materials and finished goods using technical drawings and specifications, including dimensional checks, functional testing, and visual assessments., • Record inspection outcomes in quality systems, complete necessary documentation, and flag any non-conforming items., • Apply product identification markings using laser or chemical etching methods; clean and neutralize items as needed., • Handle product returns and customer complaints by evaluating quality concerns and coordinating necessary repairs or rework., • Support regulatory compliance efforts by preparing documentation and maintaining relevant databases., • Follow all applicable quality and safety standards, including industry-specific regulations and internal procedures., • Maintain cleanliness and organization in the quality control area., • Monitor inventory of quality-related supplies and request replenishments as needed., • Provide training on inspection procedures and assist with onboarding new team members., • Uphold the organization’s quality objectives and contribute to continuous improvement efforts., • Perform additional tasks and responsibilities as assigned.Essential Skills, • Experience with inspection tools such as calipers and micrometers., • Quality Assurance experience, preferably in medical devices, though experience in pharmaceuticals is also considered., • Familiarity with Good Manufacturing Practices (GMP)., • Ability to read and interpret drawings and specifications., • High attention to detail.Additional Skills & Qualifications, • High School diploma or equivalent is required. Pay and Benefits The pay range for this position is $24.00 - $25.00/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 Emerson,NJ. Application Deadline This position is anticipated to close on Aug 26, 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 DescriptionBenefits: • Dental insurance, • Health insurance Position Overview A fast-paced, refrigerated food manufacturing and distribution facility is seeking an experienced Maintenance Supervisor to lead its maintenance team. This role is responsible for overseeing daily mechanical and electrical maintenance activities, ensuring minimal production downtime, and driving a culture of safety, preventive maintenance, and continuous improvement. Key Responsibilities • Supervise a team of maintenance technicians across multiple shifts, providing direction, training, and performance feedback, • Lead mechanical troubleshooting, repair, and preventive maintenance activities on conveyor systems, motors, gearboxes, pneumatics, VFDs, photoeyes, sensors, and other production equipment, • Coordinate and prioritize work orders to minimize production downtime and meet operational goals, • Oversee electrical diagnostics, including wiring, control panels, PLCs, and 3-phase systems (role split: ~70% mechanical, ~30% electrical), • Manage the preventive maintenance (PM) program, ensuring schedules are followed and maintenance records are accurately kept, • Collaborate closely with production, sanitation, and quality teams to ensure equipment operates safely and efficiently in compliance with GMP, OSHA, and food safety standards, • Assist in vendor coordination, spare parts inventory, and capital project support, • 5+ years of maintenance experience in a manufacturing or food production environment, with at least 2 years in a supervisory or lead role, • Strong mechanical troubleshooting and repair skills; solid electrical knowledge preferred, • Experience working with conveyors, motors, gearboxes, pneumatic systems, and production equipment, • Familiarity with PLC troubleshooting, VFDs, control systems, and basic electrical diagnostics, • Strong organizational and communication skills, with the ability to manage competing priorities in a high-pressure setting, • Experience using preventive maintenance systems (CMMS) and applying maintenance best practices, • Knowledge of GMP, OSHA, and food safety compliance standards, • Previous experience in refrigerated or food manufacturing environments, • Bilingual (English/Spanish) a plus, • Technical certifications in mechanical, electrical, or automation systems

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 Design Process Engineer (Jr) Location: Rahway, NJ (Onsite) Industries: Biopharma Full-Time | Engineering Design We are looking for a Junior Design Process Engineer with 1- 3 years of experience in the Pharma industry. Pharma industry experience is a plus. What You'll Do: As a Design Process Engineer, you'll be involved in delivering end-to-end solutions for integrated process equipment and unit operations in GMP environments, from early design through CQV. Key Responsibilities: * Conceptual, preliminary, and detailed process designs * Develop deliverables such as: * Feasibility studies, mass balances, utility sizing * Process simulations, PFDs, P&IDs, control strategies * URS, FDS, equipment specs, cost estimates * Bid packages, commissioning and qualification protocols * Guide projects from front-end engineering through start-up and CQV * Oversee equipment and utility design (e.g., fermenters, TFF, CIP systems) * Collaborate with controls, validation, and QA teams * Maintain strong relationships with multi-functional teams What You Bring: * 1+ years in GMP process engineering, ideally with skidded systems * Experience in process equipment and piping system design * Commissioning & qualification experience (automated systems preferred) * Familiarity with CAD, process control, and validation coordination * Strong communication, organization, and leadership skills * Comfortable in a fast-paced, multi-project environment This role offers true engineering creativity with exposure to a wide range of exciting, complex projects in a collaborative and technical environment. #ProcessEngineering #PharmaJobs #Biotech #CQV #GMP #EngineeringCareers

Job Description Job Title: Lab Technician Shift: 2:30 PM – 11:00 PM About the Role: We’re looking for a detail-oriented Lab Technician to join our Quality Assurance team. In this role, you’ll perform routine and advanced testing to ensure our food products meet the highest standards for safety, quality, and taste. You’ll work hands-on in a fast-paced environment, supporting production and continuous improvement efforts. Key Responsibilities: • Perform quality checks and lab tests on raw materials, in-process samples, and finished products (e.g., pH, moisture, temperature, microbiological safety)., • Conduct visual inspections and verify compliance with GMP, SOPs, and HACCP standards., • Accurately document test results and escalate any deviations or nonconformities., • Maintain and calibrate lab equipment to ensure reliable results., • Collaborate with cross-functional teams to resolve quality issues and support process improvements., • Assist in updating quality procedures and documentation., • Prepare daily shift summaries and ensure proper recordkeeping.What You’ll Bring:, • Associate’s degree or equivalent experience required., • Experience in food or manufacturing environments preferred., • Strong attention to detail and solid computer skills (Microsoft Office, ERP systems)., • Ability to work flexible hours, including weekends and rotating shifts. Pay and Benefits The pay range for this position is $17.00 - $20.00/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 Elmwood Park,NJ. Application Deadline This position is anticipated to close on Aug 27, 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 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 DescriptionQC Analytical Compliance Investigator Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. Our client is seeking a QC Analytical Compliance Investigator to lead life-cycle investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventative actions to ensure compliance. • Determine the causes and preventative actions of Deviations, Non-Conformances, OOS, OOT, field complaints and environmental excursion investigations., • Drive investigations to true root cause using appropriate investigation tools., • Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track CAPA plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Effectively utilize change management approach., • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process., • Champion CAPA plans and implementation., • Provide communication plan for on-going deviations & CAPA’s., • Effectively create and communicate CAPA plan to responsible parties., • Oversee timely completion of deviations, CAPAs, and Change Controls as necessary., • Ability to abide by quality standards.REQUIREMENTS, • BS in a Quality / Process related field., • Experience in GMP Operations and/or QA in Cell Therapies, Biotechnology or Bio-Pharma., • Root cause analysis experience in pharmaceutical or FDA regulated operation preferred., • Experience using e-Quality Management Systems preferred., • Relevant IT skills (able to work with Visio, Microsoft Project and Excel), • Ability to think strategically and tactically (detail-oriented), • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Analytical and problem-solving skills, • Strong written and oral communication skills, • Flexible and able to adapt to company growth and evolving responsibilities, • Integrity, accountability and strong dedication to regulatory compliance, • Continuous improvement mindset, • Ability to work effectively as a team and independently., • GMP Trained, Quality Systems Trained (Deviation/CAPA)Working 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. The noise level in the work environment is moderately noisy. Physical RequirementsThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Non-absorbent laboratory coats are required, as well as latex (or a non-latex substitute) gloves. When working with potentially hazardous materials that may spray, aerosol, or otherwise contact skin or mucous membranes, face shields or goggles must be worn. Heavy cryo-gloves must be used when working with liquid nitrogen. Other DutiesPlease 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 DescriptionTitle: Quality Assurance Compliance Specialist Reports to: Quality Systems Manager Department: Quality Responsibilities: • Lead and conduct investigations into failed materials and systems, including product complaints, non conformity, out of specifications and out of trends, quality incidents reporting., • Reviews and approves/confirms all new formulas in the Quality Systems., • Assist with creating and revising of Standard Operating Procedures and maintains/updates existing SOPs., • Initiates, reviews Non- conformance reports, completes Root Cause Analysis and CAPA., • Maintains Change Control Notices (CC) and effects changes to product specifications for raw materials, bulks, intermediates and finished goods., • Participates in internal and external audit process., • Perform periodic and scheduled audits of Analytical and Micro Lab per Data Integrity requirements., • Participates in product recall audits., • Maintain investigation records and associated documents., • Assist in conducting follow-up to CAPA effectiveness, including close-outs., • Using Quality Module within the ERP system, maintain evidence of manufacturing and production investigation to support current GMP processes., • Brings discrepancies to the attention of immediate supervisor for resolution., • Maintains files of existing specifications for customers and EWL codes., • Maintains files and database of customer-approvals and documents as evidence of authenticity., • Routinely reviews customer transmittal (through customer portals, emails, or facsimile, etc) of new or updated raw material specifications., • Effects changes to specification sheets as approved through proper change control requests., • Initiate Change Control Requests for Customer requested changes to raw material, intermediate/bulk, Finish Goods and specifications., • Initiate Investigations, complete root cause analysis and drive implementation of adequate/effective CAPA., • Maintains copies of approved change controls as applicable to product specification updates/revisions., • Maintains SOP binders and updates such through approved Change Controls., • Communicates new and updated SOPs to all employees at EWL., • Minimum of 2 years of college., • 3 to 5 years industry or related experience., • Previous experience in Pharma, Cosmetics, food, medical device, or allied profession., • Good Technical Writing ability., • Excellent knowledge of Word, Excel, Access, and other Windows-based programs., • Good record-keeping skills., • Ability to lift and carry up to 10 - 15 pounds.Compensation & Benefits: The approximate pay range for this position is $65,000 - $75,000. Final compensation may vary based on factors including but not limited to knowledge, skills and abilities. The benefit package includes: • Medical, Dental, and Vision Insurance, • Life Insurance, • 401k match S3SI7VZLtD

Job Description Position: Senior Validation Project Lead - Aseptic Liquid Fill Critical Utilities Location: Midwest US (Traveling) Compli, LLC was founded in 2001 to provide Commissioning, Validation and Regulatory Support Services to the Life Sciences industry. We serve pharmaceutical companies across the United States, offering a vast array of services that assist companies with exceeding their goals and objectives. In today’s world, it’s never been more important to understand regulations and quality assurance activities as they relate to operations, vendors, engineering, construction and contractors. In 2020, Compli, LLC became a wholly owned subsidiary of George Butler Associates, Inc. This acquisition allowed Compli, LLC to become part of an integrated network of services where clients have more options to engage an impressive suite of in-house services. Compli is full services Commissioning, Qualification, Regulatory Compliance and On Demand services firm. Supervisory Responsibilities: * None Essential Functions: • Support Client commissioning / validation for facility, utility, equipment, cleaning and process validation projects., • Prepare and execute commissioning / validation lifecycle documents., • Participate in any stage of clinical or commercial production including green field construction, facility renovation, new product development, product launch, or product/process upgrade., • Write summary reports for validation and qualification protocols., • Support project milestones, priorities and deadlines., • Write operating procedures for technical equipment and practices and procedures., • Perform system and process risk assessments and analyses., • Schedule and coordinate protocol execution with other departments including manufacturing, facilities and project management., • Develop project specific validation plans and strategy., • Able to manage and execute multiple projects to meet client’s priorities., • Provide a practical approach to problem solving., • Individuals must represent COMPI at client sites and interact confidently with clients, contractors, management and peers., • Bachelor's degree in a related life sciences or requisite industry training and experience., • Ability to converse about scientific matters., • Ability to work independently or in collaboration with others., • In depth understanding and application of validation principles, concepts, practices and standards., • Considered a Subject Matter Expert (SME) in one area of validation., • Proficient in current Good Manufacturing Practices and other applicable regulations., • Experienced with all pertinent industry best practices (e.g., ISPE) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report., • Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR) and internal requirements employing regulatory guidance and industry standards., • Excellent written communication skills with emphasis in technical writing., • Prolonged periods of sitting at a desk and working on a computer. At Compli, we are about innovative and intelligent people who want to solve problems. We’re known for our technical excellence, but we bring so much more to the table. We strive to create remarkable solutions for a higher quality of life. And we are changing the industry by integrating the design and construction process with use of new technology. At Compli, we are an Equal Employment Opportunity Employer promoting diversity in our workforce by including all individuals regardless of age, race, religion, color, sex, national origin, marital status, genetic information, sexual orientation, gender identity, gender expression, disability, veteran status, pregnancy status, or any other status protected by law.

Job DescriptionScientist – Engineer, MSAT The Scientist-Engineer, MSAT performs process and analytical experimental studies as part of a team that is effectively delivering cell therapy services to clients in accordance with defined scope of work, timelines, and budgets. This includes leading projects in process development, technology transfer and continuous improvement of our client's novel manufacturing processes. Our goal is to support our clients in developing commercially viable cell therapy products, so that they can become accessible to all. • Accountable for the design and execution of experimental studies in the laboratory, for example:, • Perform laboratory experiments for client projects, • Perform analytical testing for client projects, • Preparation and scheduling of laboratory equipment for experiments, • Provide technical leadership of client products during manufacturing and development, for example:, • Direct technical communication with clients during manufacturing and development, • Support manufacturing in identifying and resolving manufacturing process constraints, • Lead the generation of manufacturing and development documentation, for example:, • Generating experiment protocols and reports for development projects, • Generating draft batch records and other manufacturing documentation, • Generating manufacturing risk assessments, such as FMEA, • Perform data analysis to reach actionable conclusions, for example:, • Compile and analyze experimental data, • Present experimental data internally and externally to clients, • Supervise direct reports.REQUIREMENTS, • Bachelor's degree in relevant life science or engineering discipline, • Minimum of 3 years' experience in aseptic cell processing, cell culture and cell analytics under the guidance of scientific protocols, • Demonstrated ability to deliver projects to specific timelines and budgets, • Experience in working effectively and delegating tasks in a team-based environment, • Demonstrated ability in technical writing and the preparation of, protocols and reports, presentations and/or other communications, • Basic understanding of the technical principles, theories and concepts of cell therapy or similar products, • Aseptic processing, Good Manufacturing Practice (GMP), communication skills, specific process and analytical equipment, • This job may require occasional evening and weekend work.

Job Description We are seeking a Production Supervisor to lead and manage production staff during assigned shifts while ensuring a safe and efficient operation. The role involves mentoring team members, maintaining quality and safety standards, and driving continuous process improvements. Cross-training employees and implementing strategies to enhance productivity are also key responsibilities. Responsibilities • Ensure employee safety and high-quality production by providing proper equipment training, enforcing safety rules, maintaining documentation, following GMP protocols, and adhering to procedures and government standards in coordination with the Quality Assurance department., • Monitor and maintain efficient production by reporting food safety and quality issues, performing hourly audits, ensuring lines run at target throughput, and implementing action plans to reduce downtime and improve yield., • Manage production and employee schedules to ensure proper staffing, minimize rework, monitor yields, implement corrective actions, and build team capability through coaching, training, and effective communication., • Plan and conduct cross-training, ensure accurate daily reporting of key metrics, train new employees on machinery and procedures, and regularly evaluate equipment to maintain maximum efficiency., • Address repair issues promptly, maintain a clean and safe work environment, support cost-saving initiatives, ensure open communication across all levels, enforce safety and company policies, and perform other assigned duties. Qualifications • At least 5 years of leadership experience in a manufacturing setting or a comparable role, • Strong communication skills, • Fluency in both English and Spanish is required, • Must be available to work a flexible schedule, • Proven success working in dynamic, fast-paced, team-oriented environments, • Familiarity with production operations, safety protocols, and food quality standards is preferred, • Strong leadership qualities with effective interpersonal skills, • Highly driven and capable of working independently, • Solid math, analytical, and problem-solving capabilities, • Strong collaboration skills across various levels of the organization, • Ability to proactively address and prevent food safety, quality, and production issues, • Skilled in coaching team members and delivering clear guidance, • Well-versed in production planning and scheduling, • Proficient in Microsoft Outlook, Excel, and Word, • Must be willing to work weekends as needed by the company

Job Description We are seeking a Production Supervisor to lead and manage production staff during assigned shifts while ensuring a safe and efficient operation. The role involves mentoring team members, maintaining quality and safety standards, and driving continuous process improvements. Cross-training employees and implementing strategies to enhance productivity are also key responsibilities. Responsibilities • Ensure employee safety and high-quality production by providing proper equipment training, enforcing safety rules, maintaining documentation, following GMP protocols, and adhering to procedures and government standards in coordination with the Quality Assurance department., • Monitor and maintain efficient production by reporting food safety and quality issues, performing hourly audits, ensuring lines run at target throughput, and implementing action plans to reduce downtime and improve yield., • Manage production and employee schedules to ensure proper staffing, minimize rework, monitor yields, implement corrective actions, and build team capability through coaching, training, and effective communication., • Plan and conduct cross-training, ensure accurate daily reporting of key metrics, train new employees on machinery and procedures, and regularly evaluate equipment to maintain maximum efficiency., • At least 5 years of leadership experience in a manufacturing setting or a comparable role, • Strong communication skills, • Fluency in both English and Spanish is required, • Must be available to work a flexible schedule, • Proven success working in dynamic, fast-paced, team-oriented environments, • Familiarity with production operations, safety protocols, and food quality standards is preferred, • Strong leadership qualities with effective interpersonal skills, • Highly driven and capable of working independently, • Solid math, analytical, and problem-solving capabilities, • Strong collaboration skills across various levels of the organization, • Ability to proactively address and prevent food safety, quality, and production issues, • Skilled in coaching team members and delivering clear guidance, • Well-versed in production planning and scheduling, • Proficient in Microsoft Outlook, Excel, and Word, • Must be willing to work weekends as needed by the company

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 35 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 DescriptionJob Title: QC Technician Job Description The QC Technician will play a crucial role in ensuring the quality and safety of bread production by conducting line audits, environmental monitoring, and air sampling. This position involves participating in monthly SQF audits, calibrating and verifying scales, monitors, and basic instrumentation, and documenting practices using MS Excel, Word, and Office. The technician will monitor and verify product quality throughout the manufacturing process in accordance with GMP standards and perform visual inspections, product weight checks, and other quality assessments. Addressing food safety issues and customer complaints in collaboration with QA Supervisors is also part of the role. Responsibilities • Conduct line audits and environmental monitoring for bread production., • Participate in monthly SQF audits., • Calibrate and verify scales, monitors, and basic instrumentation., • Utilize MS Excel, Word, and Office for documentation., • Monitor and verify product quality throughout the manufacturing process., • Perform visual inspections, monitor product weights, codes, and labeling., • Address food safety issues and customer complaints with QA Supervisors., • Handle other periodic tasks as assigned.Essential Skills, • Quality control experience in the Food and Beverage industry., • Strong communication skills., • Adaptability to change in a Pastry Production facility., • High School Diploma., • Knowledge of Food Safety practices including SQF, FSMA, or HACCP., • Proficiency in Microsoft Word, PowerPoint, and Excel.Additional Skills & Qualifications, • Bilingual abilities., • Experience in GMP environment., • Environmental Monitoring skills. Pay and Benefits The pay range for this position is $25.00 - $27.00/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 Paterson,NJ. Application Deadline This position is anticipated to close on Aug 28, 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 DescriptionQuality Control Manager The Quality Control (QC) Manager plays a pivotal role in ensuring that QC is effectively serving in its support role to clinical and commercial production. The QC Manager will ensure that analytical testing for process check points, stability, and release assays are being carried out to certify that quality standards are upheld for all products produced at the facility. The goal is to ensure that the Quality Control group and company is constantly moving towards fulfilling its short-term and long-term objectives and does not diverge from its strategic guidelines. Under the direction of the VP, Global Quality Head, responsibilities of the QC Manager will include but are not limited to: • Leading, hiring, developing, training, and evaluating QC personnel, • Devising sound hiring strategies based on business needs, • Supervising and overseeing QC personnel in their roles for safe and efficient verification, approval, release/disposition of HCATS and/or client products/materials, • Delegating responsibilities and supervising the work of laboratory personnel, while providing guidance and motivation to drive maximum performance, • Ensuring and promoting compliance with applicable cGMP and GTP regulations, while ensuring compliance with company and client methodologies, • Assuring alignment and efficient continuity in laboratory practices between sites, • Serving as approver in investigations while overseeing timely closure of deviation reports, change controls, CAPAs, and applicable batch records, • Ensuring completion of all client QC requirements related to GMP cellular products and/or materials, • Overseeing QC role in material dispositions via deviation reporting system, CoAs, and/or client-based systems, if applicable, • Prioritizing, scheduling, and managing multiple projects and resources simultaneously, • Monitoring effectiveness of quality systems, change control activities and their completion, for both, internal and client audit findings, • Evaluating and investigating customer complaints and deviations; coordinating corrective and preventive actions as they relate to the Quality Control function, • Delegating maintenance, tracking, and trending aspects of the deviation reporting system, • Developing and maintaining Key Performance Indicators (KPIs) for laboratory testing, • Interfacing with vendors, suppliers, and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies, when applicable, • Interfacing with management at all levels for alignment on significant deviation resolution and corrective action implementation, • Delegating development, revisions, and implementation of Standard Operating Procedures as related to Quality Control activities, • Participating in and tracking group budget setting and cost containment drives, • Communicating and maintaining trust relationships with senior management, business partners, and clients, • Ensuring company policies and legal guidelines are communicated top-down in the company and that they are followed at all times, • Completing projects and special tasks as assigned by the Global Quality Head, • Off-schedule shifts during weekends and holidays based on business requirements a possibility, • On-call presence preferred while physical personal presence is not possible, • Candidate will oversee QC Scientist and QC Associate I, II, and III roles. The QC Manager will delegate responsibilities to direct reports to achieve the requisite business needs, while providing ongoing support to Manufacturing processes.REQUIREMENTS, • BA/BS/MS in a science or relevant field required, • Master’s in Business Administration or relevant field will be preferred, • 7 – 10 years’ experience in the pharmaceutical, biologics or related industry, • Prior cGMP experience required, • Prior QC laboratory, clinical laboratory, microbiology, hematology, blood banking, or immunology experience in a CGMP/GTP environment a must, • Experience in Flow Cytometry is a must, • 5 + Years experience leading a team is a must. Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff, • Sound understanding of current Good Manufacturing Practices (cGMPs), • Working knowledge of routine QC laboratory procedures such as flow cytometry and CBC analysis, endotoxin testing, equipment and systems, and understanding of production processes and validation, • Prior experience with reviewing Standard Operating Procedures, work instructions, protocols, methods, method validations preferred, • Proven experience in a supervisory or managerial position, • Demonstrable experience in developing strategic plans based on business needs, • Strong understanding of Quality Control in pharmaceutical/biotechnology/biologics industries, • Thorough knowledge of market changes and forces that influence the company, • Proficient with computer software: Microsoft Office, Visio, • Strong written, oral, and presentational skills, • Strong knowledge of QC Analytical testing methodologies, philosophies, method validation and method transfers, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review, • Excellent organizational and leadership skills, • Excellent communication, interpersonal, and presentation skills, • Outstanding analytical and problem-solving abilities, • Strong business acumen, • Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner, • Candidate must be detail oriented, can multi-task, work in a team environment, and have the flexibility to adapt to company growth as well as its evolving responsibilitiesWhile 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. The noise level in the work environment is moderately noisy. Must have the ability to work in a team-oriented environment and with clientsMust be able to handle the standard/moderate noise of the manufacturing facility 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 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 The position of Senior Regulatory Affairs Specialist is responsible for preparing regulatory submissions (e.g. INDs, IDEs and PMAs) for North America as well as assisting in the implementation of the company’s quality goals and objectives. Other responsibilities include assisting with compliance activities related to ISO, GMP and applicable medical device standards. This role will report directly to the Director of Regulatory Affairs and collaborate with other team members within the regulatory department as needed. 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 inclusive, and the person will be expected to complete tasks reasonably requested by the Director of Regulatory Affairs. This is a flexible on-site position in Madison, NJ and may require up to 5% travel domestically or internationally. Major Responsibilities Under direction from the Director of Regulatory Affairs, the Senior Regulatory Affairs Specialist will be responsible for: · Providing regulatory affairs support for projects related to Digital Health, Software, Cybersecurity, Combination products and other new venture initiatives. · Supporting pre-market and post-market regulatory activities for assigned projects. · Collaborating with cross-functional teams to provide regulatory support. · Preparing regulatory submissions (IDE; IDE Supplements; PMA; PMA Supplements, etc.) for submission to the FDA and Health Canada. · Interfacing with the FDA and Health Canada on assigned projects. · Responding to FDA and Health Canada requests for additional information. · Keeping abreast of changes to US and Canada regulatory requirements and International Standards related to OrganOx products and processes. · Formally communicating regulatory initiatives or changes in the applicable medical device law with company personnel, customers, subcontractors, regulatory agency representatives, and third-party organizations. · Perform regulatory change assessments as required. · Reviewing applicable regulatory guidance and standards for assigned projects to ensure compliance with regulations and determining regulatory impact. · Prepare visualizations and conclusions for presentation to upper management. · Working with key stakeholders in relation to Regulatory topics. · Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies. Requirements · Skills and Experience · Working knowledge of FDA processes for medical device compliance. · Experience with Software as a Medical Device (SaMD), Cybersecurity and Combination products is preferred. · Experience with Class II and Class III devices. · The ability to write clear regulatory strategies and submissions. · A good understanding of GMP compliance requirements in Quality Control. · Experience in cross-functional collaboration with Manufacturing, Quality, R&D, Clinical and Marketing departments. · Computer proficiency in MS Office (i.e., Word, Excel, PowerPoint) · Excellent verbal and technical writing skills. · Ability to work independently. Qualifications The Senior Regulatory Affairs Specialist will have: · A minimum of a Bachelor’s degree in engineering, life sciences, or other related area · A minimum of 3-8 years of related regulatory experience (depending on education level) with Class II/III medical devices · Regulatory Affairs Certification (RAC) (Optional) · Ability to travel 5% of the time domestically or internationally. #LI-Onsite 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 $115,000 - $140,000 annually, with a 10% target annual bonus and benefits. At OrganOx, 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 DescriptionJob Title: Quality Control Laboratory Technician Job Description The Quality Control Laboratory Technician will be responsible for using micrometers and calipers to measure incoming instruments, ensuring they meet required specifications. The technician will review drawings and instruments to confirm product alignment, report on part conditions, and identify any non-conformances. The role involves updating the QMS system and paper documents for audits, utilizing Good Manufacturing Practices (GMP), and handling product returns and customer complaints. This position supports regulatory compliance efforts and contributes to continuous improvement initiatives. Responsibilities • Measure incoming instruments using micrometers and calipers to ensure compliance with specifications., • Review drawings and instruments to verify product conformity., • Report on conditions of parts and identify non-conformances., • Review customer drawings for custom OEM orders to ensure products meet specifications., • Update QMS system and paper documents for audits., • Utilize Good Manufacturing Practices (GMP) in all processes., • Receive and unpack incoming shipments, verify quantities, and assess condition of materials., • Perform inspections on raw materials and finished goods using technical drawings and specifications, including dimensional checks, functional testing, and visual assessments., • Record inspection outcomes in quality systems and complete necessary documentation., • Flag any non-conforming items., • Apply product identification markings using laser or chemical etching methods., • Clean and neutralize items as needed., • Handle product returns and customer complaints by evaluating quality concerns and coordinating necessary repairs or rework., • Support regulatory compliance efforts by preparing documentation and maintaining relevant databases., • Follow all applicable quality and safety standards, including industry-specific regulations and internal procedures., • Maintain cleanliness and organization in the quality control area., • Monitor inventory of quality-related supplies and request replenishments as needed., • Provide training on inspection procedures and assist with onboarding new team members., • Uphold the organization’s quality objectives and contribute to continuous improvement efforts., • Perform additional tasks and responsibilities as assigned.Essential Skills, • Proficiency with micrometers and calipers., • Quality assurance and quality control experience., • Familiarity with Good Manufacturing Practices (GMP)., • Ability to read drawings and specifications., • Attention to detail.Additional Skills & Qualifications, • High School diploma or equivalent. Job Type & Location This is a Contract to Hire position based out of Northern New Jersey. Pay and Benefits The pay range for this position is $24.00 - $25.00/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 Paramus,NJ. Application Deadline This position is anticipated to close on Aug 27, 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 Job Title: Production Support Engineer II Department/Division: Engineering Reports to: Manager- Mechanical Engineering 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: As a Production Support Engineer, you’ll provide mechanical engineering services in a pharmaceutical manufacturing environment. You’ll support plant maintenance teams and ensure the efficient service of production machinery, equipment, utilities, and facilities—all while focusing on production uptime and metric improvements. This is a full-time onsite position located in West Caldwell, NJ • This role supports our 1st shift starting between 7:00am to 9:00am for 8 working hours Monday through Friday, • Some on-call required What You Will Do: • Spend days "on the floor" troubleshooting and resolving production issues to manufacturing maintain continuity., • Support spare parts management, procurement, and inventory., • Lead small equipment improvement projects and vendor evaluations., • Write and execute GMP documentation including SOPs, CAPAs, and Change Controls., • Support maintenance planning and preventive calibration., • Maintain engineering documentation and technical libraries., • Serve as a subject matter expert across various manufacturing systems., • Bachelor’s degree in Mechanical Engineering or related field., • 2-3 years of experience in pharmaceutical, manufacturing, or packaging preferred, • Strong customer service orientation, • Strong mechanical and mathematical skills., • Basic computer and communication skills., • Ability to wear required PPE and lift up to 24 lbs., • Experience with Minitab/AutoCAD helpful., • Ability to visualize and troubleshoot equipment issues., • Experience integrating new innovations into existing methods., • Knowledge of GMP protocols and regulatory compliance., • Strong documentation and organizational abilities., • Leadership and collaboration across global teams. If this sounds like you, we want to hear from you! 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 Description Position: Senior Validation Project Lead - Medical Devices, Life Sciences Group Location: Midwest US (Traveling) Compli, LLC was founded in 2001 to provide Commissioning, Validation and Regulatory Support Services to the Life Sciences industry. We serve pharmaceutical companies across the United States, offering a vast array of services that assist companies with exceeding their goals and objectives. In today’s world, it’s never been more important to understand regulations and quality assurance activities as they relate to operations, vendors, engineering, construction and contractors. In 2020, Compli, LLC became a wholly owned subsidiary of George Butler Associates, Inc. This acquisition allowed Compli, LLC to become part of an integrated network of services where clients have more options to engage an impressive suite of in-house services. Compli is full services Commissioning, Qualification, Regulatory Compliance and On Demand services firm. Supervisory Responsibilities: * None Essential Functions: • Support Client commissioning / validation for facility, utility, equipment, cleaning and process validation projects., • Prepare and execute commissioning / validation lifecycle documents., • Participate in any stage of clinical or commercial production including green field construction, facility renovation, new product development, product launch, or product/process upgrade., • Write summary reports for validation and qualification protocols., • Support project milestones, priorities and deadlines., • Provide project reporting (budgets, status and scheduling reports), • Write operating procedures for technical equipment and practices and procedures., • Perform system and process risk assessments and analyses., • Schedule and coordinate protocol execution with other departments including manufacturing, facilities and project management., • Develop project specific validation plans and strategy., • Able to manage and execute multiple projects to meet client’s priorities., • Provide a practical approach to problem solving., • Individuals must represent COMPI at client sites and interact confidently with clients, contractors, management and peers., • Bachelor's degree in a related life sciences or requisite industry training and experience., • Ability to converse about scientific matters., • Ability to work independently or in collaboration with others., • In depth understanding and application of validation principles, concepts, practices and standards., • Considered a Subject Matter Expert (SME) in one area of validation., • Proficient in current Good Manufacturing Practices and other applicable regulations., • Experienced with all pertinent industry best practices (e.g., ISPE) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report., • Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR) and internal requirements employing regulatory guidance and industry standards., • Excellent written communication skills with emphasis in technical writing., • Prolonged periods of sitting at a desk and working on a computer. At Compli, we are about innovative and intelligent people who want to solve problems. We’re known for our technical excellence, but we bring so much more to the table. We strive to create remarkable solutions for a higher quality of life. And we are changing the industry by integrating the design and construction process with use of new technology. At Compli, we are an Equal Employment Opportunity Employer promoting diversity in our workforce by including all individuals regardless of age, race, religion, color, sex, national origin, marital status, genetic information, sexual orientation, gender identity, gender expression, disability, veteran status, pregnancy status, or any other status protected by law.

Job DescriptionCompany Description Stratas Foods LLC is the leading supplier of fats and oils to the Foodservice, Food Ingredients and Retail Private Label markets in North America and is a producer of quality bulk and packaged dressings, mayonnaise and sauces. Stratas Foods was formed in October 2008 as a 50/50 joint venture between ACH Food Companies (ACH) and Archer Daniels Midland (ADM). Manufacturing facilities are located in Dallas and Houston, TX; Decatur and Quincy, IL; Englewood and Hillside, NJ; Fresno, CA; Nashville, TN; and Valdosta, GA. Corporate offices are located in Memphis, TN. We are committed to maintaining a progressive workplace by utilizing the ideas, skills and talents of all of our employees. We strive to make Stratas Foods a great place to work and are building a team capable of meeting our business goals. Job Description The Plant Project Engineer I will provide engineering support and project leadership for the plant The expectation is that this role will spend approximately 60% of the time on project related activities and 40% of the time on plant support activities. At times either activity could exceed expectation. The Plant Project Engineer I role will include project implementation, production and equipment improvement initiatives and support the daily operations of the plant to ensure all safety and quality goals are achieved. Qualifications • Project management, project planning, project coordinator, purchasing, and supervision of contractors for various projects to assure completion on a timely basis within budget., • Adhere to and enforce Good Manufacturing Practices (GMP) and HACCP requirements., • Lead and assist management with appropriate training to assure regulatory compliance., • Report to the Director of Engineering with a dotted line to the Plant Manager., • Maintain appropriate communication/relationships with all employees, vendors, visitors., • Provide the necessary safety training to contractors and others as necessary., • Follow, monitor, and ensure compliance with all safety, food safety, environmental, GMP rules, regulations, and policies., • Attend daily production/quality meetings., • Provide technical support for plant processes and improvements., • Observe facility operations and assist with problem solving on a regular basis., • Excellent oral and written communication skills with proven ability working well with people., • Ability to identify critical areas for improvement and develop plans for correction., • Competent in making sketches, drawings, line layouts, plans etc., and written instructions as necessary to affect equipment maintenance / repair., • Participative team attitude skills with all personnel to assure production standards, safety, and sanitation levels are maintained as defined by the Mission Statement., • Good skills in ammonia refrigeration, steam generation and PLC’s., • Good problem solving skills through team and individual efforts. BS degree in engineering or technical related area from an accredited college/university; Chemical, Electrical, or Mechanical preferred Related Experience Proven Engineering experience of 3 – 5 years, project management is a plus Equipment/Software Skills Working knowledge in personal computers (Microsoft software necessary, Project management, Microsoft Project preferred) and basic understanding with Allen Bradley PLC. Knowledge of CMMS such as MP2 is a plus. Must have good working knowledge of general PC systems. Certifications, Licenses, Registrations None required, any maintenance related licenses would be a plus such as PE, ASME welding, PLC’s , wastewater, etc. Additional Information Physical: While performing the duties of this job, the employee is regularly required to walk, sit, and stand. The employee will also be required to use hands, arms and fingers. Must have the ability to lift 50 pounds. Ability to walk distances across facility, climb steps and ladders on occasions, sitting at office desk work, sometimes in cooler atmosphere ( 35-45 degrees) , sometimes in engine room ( + 95 degrees in hot months). Language Bi-lingual is preferred Sensory: Visual, speaking, and touch is essential. Mental/Reasoning: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form Benefits: Medical, Dental, Vision Stratas Foods is an equal opportunity employer and will not discriminate against any applicant or employee in any manner prohibited by law, including but not limited to, on the basis of race or color, religion, gender, age, genetic information, national origin/ancestry, mental or physical disability, family status/marital status, military/veteran status, and any other legally protected status. Pay Transparency Nondiscrimination Provision-The Employer will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the Employer’s legal duty to furnish information. 41 CFR 60-1.35(c) Stratas Foods Applicant Request for Accommodation Form: Stratas Foods California Privacy Rights Act Policy:

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: As Senior Manager, Healthcare Regulatory Intelligence, you are a market-facing thought leader, leveraging your extensive background in regulation and compliance within highly regulated Life Sciences institutions. Your experience, ideally including roles within regulation, compliance and regulatory governance, will contribute to a distinct team of subject matter experts at Global Relay, enhancing our brand value both internally and externally. Your primary challenge will be optimizing productivity amidst a diverse and unstructured role, requiring flexibility and autonomy. Reporting to the Global Head of Regulatory Intelligence (UK), the role will have regular formal and informal interactions. Supervisory guidance will be available to support your efforts, while allowing for autonomous work. Your responsibilities: Internal responsibilities: • Support and enhance brand awareness for the New York office across all relevant stakeholders, • Provide marketing support by assisting with PR, messaging in collateral, and content for marketing events, that elevate Global Relay's brand recognition, • Assist in business development efforts by participating in key customer meetings and briefings, and be ready to share your subject matter expertise, • Offer support to product teams by advising on market practices, challenges, competitor offerings, and regulatory expectations, • Contribute to Global Relay Intelligence & Practice (GRIP), our business' daily regulatory content service, by writing articles, providing editorial input, and participating in interviews for multimedia content, • Contribute to internal training materials, educating those less familiar with Life Science best practice, and business development teams on market dynamics and compliance processes, • Stay abreast of regulatory changes by regularly consuming and filtering relevant news sources, and disseminating insights across the organization, • Participate in Executive Briefings (extensive prospect and client meetings), collaborating on workshops and product pitches to customers and prospects, • Work in close collaboration with product teams to ensure innovative solutions meet specific compliance requirements and mitigate risks effectivelyExternal responsibilities:, • Host and lead industry roundtables, facilitating discussions on evolving compliance practices and attending social events to engage with compliance officers, • Speak on panels and as a keynote speaker at industry events, representing Global Relay and staying informed about market trends and competitor positioning, • Utilize your extensive network of regulatory and compliance practitioners to raise awareness of Global Relay's capabilities and stay updated on market practices, • Minimum of 10 years of experience in a regulatory or compliance role within the Life Sciences industry (particularly pharmaceutical manufacturing), with a demonstrated understanding of Healthcare and Life Sciences laws and regulations, • Bachelor's degree in a relevant field, ideally with additional certifications or advanced degrees (such as a law degree or CPA), • Familiarity with 21 CFR Part 11, Good Manufacturing Practices (GMP), FDA, EMA, ICH, and DOJ ECCP, • Strong communication skills, both written and verbal, with the ability to articulate complex regulatory concepts clearly and persuasively, • Ability to work autonomously and collaboratively within a cross-functional team environment, demonstrating flexibility and adaptability to changing priorities, • Experience in "mobile device compliance challenges, e.g. ephemeral messaging," as well as SaaS electronic message archiving, compliance, and supervision in highly regulated industries, • Excellent project management skills, including the ability to manage multiple projects simultaneously and drive them to successful completion 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, corporate bonuses, and a 401(k) retirement plan with company contribution matching. For employees based 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! New York - Base Salary Range:$150,000—$220,000 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 DescriptionQuality Control Manager, Training & ComplianceAllendale, NJ The Quality Control (QC) Manager, Training and Compliance will manage the training and compliance programs across the analytical and microbiological laboratories. This role will ensure that there is a robust training program for the analytical and microbiological laboratories. In addition, this role will manage compliance activities within the laboratory such as deviations, CAPAs, document review, etc. The QC Manager will also be responsible for the management of external laboratories to include development of Quality Agreements, review of test results and resolution of any issues. • Develop and maintain training program within Quality Control which includes, onboarding and continuous training, • Manage deviations, CAPAs, change controls and document review to ensure compliance, • Ensure OOS investigations are completed adequately., • Manage external laboratories to include development of Quality Agreements, monitoring of samples and test results, reviewing deviations/OOS investigations, resolving issues and developing a scorecard to monitor the quality performance of the external laboratories, • Identify resources needed for training and compliance and build team accordingly, • Ensure compliance with applicable cGMP regulations while ensuring compliance with company and client requirements., • Monitor effectiveness of CAPAs, change control activities, and audit observation closure., • Directly supervises 1-4 employees within the Quality Control department(s).Directly supervised the following roles - Technical Trainers, Compliance Investigators, • Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions. REQUIREMENTS, • BA/BS/MS in a science or relevant field required, • Prior cGMP experience required, • Prior QC laboratory experience in a cGMP environment a must, • 3-5 years’ experience in the pharmaceutical, biologics ore related industry, • Proven ability to lead, coach, and motivate employees, clearly communicate job requirements and effectively manage performance of assigned staff with a minimum of five (5) years in a management position, • Sound understanding of cGMPs, • Experience in laboratory training and compliance, • External laboratory management experience, • Strong knowledge of testing methodologies, philosophies, method validation and method transfers., • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review, • Ability to think strategically, tactically (detail-oriented), and advise personnel in an effective manner, • Experience with laboratory training programs, • Knowledge of GMP requirements, • Excellent organizational and leadership skills, • Outstanding analytical problem-solving abilitiesWhile 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. 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 Summary The Quality Validation Specialist will be responsible for ensuring that finished products meet company standards through inspecting, assessing, and testing of products, integrations, and implementations of new equipment and processes. The candidate will support the day-to-day activities pertaining to the lab, customer complaints, environmental monitoring, and validations (equipment, cleaning, process and products). The ideal candidate must understand lab procedures and process validation strategies. The position will report directly to the Lab Supersivor with oversight by the QA Manager. This role offers responsibility, variety and the satisfaction that your role makes a real impact on our success Responsibilities • Assist QA management with implementing various quality systems (SQF, Organic, Kosher, RSPO, UTZ, etc.), • Assist with lab testing, sample collection, sensory evaluation, shelf-life retention monitoring, • Communicate corrective actions to suppliers/vendors., • Assist in implementation of corrective actions required as a result of an audit or internal finding, • Communicate nonconforming products to appropriate personnel., • Write technical reports and supporting documentation such as deviation, CAPAs, reports, testing protocols, and trend analyses preventative/corrective actions. Ensure timely closure of investigations., • Participate in internal audits for compliance with SOPs, GMPs, and regulations., • Participates actively in technology transfer, method qualification and validation., • Experienced with GFSI and HACCP Scheme (SQF, BRC), • HACCP and PCQI Certified is not required but a plus, • 1-2 years of relevant work experience in a medical device, pharmaceutical, or food processing industry field., • Knowledge of Regulations and Standards: Familiarity with relevant regulations and standards, such as cGMP (Current Good Manufacturing Practices) GMP experience in manufacturing environment., • Working knowledge of safety rules, regulations and training., • Bilingual (Spanish/English), • Good Communication skills: Ability to communicate effectively with technical and non-technical personnel., • Technical Writing: Intermediate to advance, • Problem-Solving Skills: Ability to identify and resolve issues related to validation activities., • Strong working knowledge of Microsoft Excel, Microsoft Word, Microsoft PowerPoint and Microsoft Outlook, • The ability to solve practical problems or issues and report in a high level, • Ability to work in a team environment, • Scientific Background: Typically requires a bachelor's degree in a scientific field, such as biology, chemistry, or engineering., • Technical Proficiency: Familiarity with laboratory equipment and validation techniques, methodologies., • Analytical Skills: Strong analytical skills to evaluate data and identify trends.

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 Description Job Description One of the nation’s largest independent testing facilities seeks a Stability and Study Coordinator with a minimum of 2 years stability systems experience in a GMP environment. The perfect candidate will also have previous experience as an Analytical Chemist with a minimum 2 years experience testing products for the pharmaceutical, nutritional cosmetic, personal care, medical device or allied industries. The position requires a working knowledge of testing products in a GMP regulated facility. Must have the technical ability to understand client requirements, technical documentation, and be able to prepare testing protocols. Responsibilities include, but are not limited to the following: • Communicates with clients regarding studies to ensure timely processing and submission to the laboratories., • Entry of stability studies and all associated information into company software system and communicates the stability testing schedules to department management., • Performs time point pulls within the acceptable guidelines and documents details as per SOPs, customer and regulatory requirements., • Submission of the stability samples to the appropriate departments., • Develops and generates stability study protocols according to customer requirements and timelines, internal SOPs and regulatory requirements., • Compilation of time point raw data and verification of results entry into stability system as well as generation of interim and summary time point data and reports., • Prepares the generation of shelf life summary reports for products based on compiled data., • Coordinates with department management regarding stability workload and schedules to ensure timelines are met., • Preparation of sample shipments and paperwork for returned samples., • Entry of routine, development and validation studies and all associated information into company software system and communicates the study details to department management., • Documents work clearly and accurately., • Perform technical writing and peer review as needed, • Capable of working in a fast paced environment. Education and Experience • Bachelor's degree in chemistry or other related degree, preferred., • Minimum 2 years of stability systems experience in a GMP laboratory., • Minimum 2 years of product testing experience in a GMP laboratory., • ISO 17025 experience a plus., • Excellent scientific and organizational skills., • Strong communication skills (written and oral) with an attention to detail., • Ability to learn new techniques, multitask, follow instructions and comply with SOPs., • Self motivated and have the ability to work independently and as part of a team., • Ability to stand/sit in office and laboratory environment., • Ability to use a personal computer and Microsoft Office (Word, Excel, Outlook) experience required., • Vision accuracy and color detection are required for this position, • Ability to wear/use personal protective equipment as required such as lab coat, goggles, gloves, masks, etc., • Ability to lift up to 30 lbs. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age or any other characteristic protected by law. Company DescriptionConsumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.Consumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.

Job Description Job Title: Quality Control Manager / SQF Practitioner Location: Paterson, NJ Type: Full-Time | On-Site About the Role: We’re looking for a passionate, hands-on Quality Control Manager with SQF Practitioner certification to lead all quality assurance and food safety efforts at our Clifton, NJ facility. In this role, you’ll ensure every product that leaves our doors meets the highest standards of safety, consistency, and what we call “the perfect pop”—our gold standard for excellence rooted in custom recipes, craftsmanship, and care. This is a critical leadership position for someone who thrives in a fast-paced environment, has a deep understanding of food manufacturing, and believes in empowering others to take ownership of quality. Key Responsibilities: Lead all food safety and quality programs, including SQF, HACCP, GMP, FSMA, and internal QA/QC protocols. Serve as the on-site SQF Practitioner, ensuring full compliance and maintaining documentation. Oversee and mentor the QA/QC team, promoting a culture of pride, accountability, and continuous improvement. Conduct daily product and process inspections to monitor for consistency in seasoning coverage, size, and quality. Maintain and manage all records for traceability, lot codes, packaging verification, microbiological testing, and audit readiness. Lead internal, third-party, and regulatory audits (FDA, USDA, etc.). Investigate quality complaints and non-conformances, lead root cause analysis and implement CAPAs. Collaborate cross-functionally with Production, R&D, and Supply Chain to drive systemic improvements. Monitor incoming raw materials and finished products to ensure they meet established specs. Maintain and update SOPs, training programs, and the Food Safety & Quality Manual. Manage shelf-life testing, environmental monitoring, allergen controls, and sanitation verification. Ensure compliance with federal labeling standards (NF labeling knowledge is a plus). Publish and maintain weekly QA technician audit and rotation schedules. Required Qualifications: Bachelor’s Degree in Food Science, Microbiology, Chemistry, or related field. Certified SQF Practitioner (required). HACCP Certification (required). Minimum 5 years of food QA/QC experience, with at least 3 years in a leadership role. Strong knowledge of food safety regulations, quality systems, and industry certifications. Comfortable with documentation systems and software (Microsoft Office; NetSuite a plus). Bilingual in English and Spanish strongly preferred. Strong leadership, communication, and team-building skills. Physical Requirements & Work Environment: Ability to walk, stand, bend, and use hands/fingers consistently throughout the shift. Must be able to lift up to 60 lbs and work in environments with varying temperatures, noise levels, and exposure to allergens, dust, or cleaning chemicals. Use of PPE such as gloves, safety goggles, or lab coats as required. Ability to access elevated platforms or confined spaces if needed. Why Join Us? We’re more than just a food manufacturing facility—we’re a tight-knit team that believes in doing things the right way. You’ll have the chance to make a real impact, build a strong team culture, and take pride in every product we send out the door. Job Type: Full-time Benefits: 401(k) Paid time off Language: Spanish (Required) Ability to Commute: Clifton, NJ 07011 (Required) Work Location: In person

Job DescriptionThis is a temporary 6-month contracted 1099 position with no benefits. • Interprets customer specifications to define requirements for mechanical designs., • Performs first principal analysis related to appropriate aspects of mechanical design., • Applies the 3D CAD system to create mechanical design and drawings., • Develops detailed fabrication and assembly drawings and performs tolerance analysis., • Develop prototypes for design evaluation., • Troubleshoot and resolve design & processing issues., • Contributes to details of design documentation using electronic documentation systems., • Collects, analyzes and interprets data to propose recommendations., • Develops & execute design verification protocols and technical reports., • Work with internal and external resources on fabrication, inspection, and testing of new product parts and assemblies., • Develop & debug prototype tooling / equipment and processes., • Develop test methods and fixtures., • Formulate plans & methods to accomplish assignments with appropriate oversight., • Works independently and prioritizes assigned tasks with guidance., • Contribute to project planning activities., • Design for Manufacturability and Assembly, DFM&A (cost/tooling/process considerations), preferably using SolidWorks CAD software., • Understanding in design and development of injection molded plastic, plastic extrusion, casting, sheet metal, metal stampings, additive manufacturing processes, and machined metal components, and assemblies with high part counts highly desirable., • Knowledge of mechanical design and development using metric ANSI/ISO dimensioning and drafting standards highly desirable., • Understanding of GD&T, mechanical measurement and testing equip., and statistical analysis of test data., • Experience with electronic document control systems in medical device and/or medical equipment design and development., • Highly skilled at analytical reasoning, mechanism design, creative problem solving, and mathematical analysis., • Ability to create and meet scheduled timelines (manage and coordinate tasks as required)., • Ability to work in a team environment., • Strong communication skills., • Competent in use of Microsoft Office tools., • Ability to operate test equipment such as various pressure and flow measurement equipment, temperature/humidity chambers, PC-based data recorders, simulators, DVM’s and oscilloscopes., • Familiarity and the ability to operate basic shop equipment such as hand tools, a drill, and Dremel., • Understand & interpret simple wiring diagrams., • BS in engineering discipline, mechanical preferred., • Minimum 2-4 years related experience, or an MS and less than one year experience., • Experience with a solid modeling CAD program, preferably Solidworks., • Experience in medical equipment / device design with experience in electromechanical, electro-pneumatic, and/or blood pumping equipment development., • Knowledge in medical device industry regulations and practices – ISO 13485, ISO 7198 & GMP., • Proficiency with Microsoft Windows, MS Office applications, and Adobe Acrobat., • Experience with Microsoft Visio and Microsoft Project preferred. Important Notice: Protecting Your Information Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to . Powered by JazzHR c1QYkE11NQ

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: \tPatty Press Set Up \tUse the correct patty plate and metal guide bars for the item you are running, and set up line conveyors, fryers, and the freezer to the proper temperatures. \tCheck and add Oil when necessary. \tMust be able to Operate an (Electric Pallet Jack) Safely and properly. \tPatty Presses area must be kept clean, Including catch pans and Floor drains. \tReport issues of equipment failure to the appropriate department head (i.e. supervisor/maintenance), quickly identify these problems, and find ways to resolve them, so as to minimize downtime and daily goals without compromising the safety and quality of the product. \tEnsure that the product meets target weights, Fry times, and temperature throughout production. \tEnsure that all members of Dr. Praegers team are following company policies and that SAFETY and QUALITY regulations are being enforced to be our #1 priority. \tEnsure that GMP requirements by all workers are followed. \tInspect the product to determine that the quality of the product meets QA standards and report any issues to the supervisor /and Manager. \tComplete and submit all required production documentation in compliance with GMP and verify the accuracy of all information. \tMaintain sanitary machines, equipment, and conveyors. 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. $17.00 - $17.00 Hourly

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 History Responsibilities: Patty Press Set Up Use the correct patty plate and metal guide bars for the item you are running, and set up line conveyors, fryers, and the freezer to the proper temperatures. Check and add Oil when necessary. Must be able to Operate an (Electric Pallet Jack) Safely and properly. Patty Presses area must be kept clean, Including catch pans and Floor drains. Report issues of equipment failure to the appropriate department head (i.e. supervisor/maintenance), quickly identify these problems, and find ways to resolve them, so as to minimize downtime and daily goals without compromising the safety and quality of the product. Ensure that the product meets target weights, Fry times, and temperature throughout production. Ensure that all members of Dr. Praegers team are following company policies and that SAFETY and QUALITY regulations are being enforced to be our #1 priority. Ensure that GMP requirements by all workers are followed. Inspect the product to determine that the quality of the product meets QA standards and report any issues to the supervisor /and Manager. Complete and submit all required production documentation in compliance with GMP and verify the accuracy of all information. Maintain sanitary machines, equipment, and conveyors. Physical requirements: Ability to lift and carry at least 50 lbs. Must be able to stand/walk for extended periods of time and frequently push, pull, bend, and reach. Skills (required): Strong communication skills Ability to work in a team environment. Bilingual 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. $17.00 - $17.00 Hourly

Job DescriptionPosition Description: Founded in 1994 by two heart surgeons, Dr. Praegers carries a legacy of encouraging sensible eating through nutritious and delicious frozen foods. Our journey began with a simple mission: to promote wholesome eating that is easy and delightful. Learn more about our story: Dr. Praegers History Company Culture is at Our Core: Our Core Values are more than just words, they are a way of life. We know that companies with a strong culture and a higher purpose perform better in the long run. Do our values speak to you? GRIT \tRise to the Challenge \tBe Determined \tEncourage Risk-Taking IMPACT \tCollaborate for Impact \tContinuously Improve \tSpeed over Perfection CARING \tDemonstrate Ownership \tCelebrate Achievements \tFoster Belonging WHAT YOU WILL BE DOING: Weigh raw materials using company formulas to measure and stage various dry and liquid ingredients in preparation of production. Job Responsibilities \tWeigh ingredients according to formula using proper weighing techniques. \tPlace measured ingredients into V-mag dump buggy, plastic bag or in mixer. \tUse sensory observations to spot potential quality issues and inform supervisor accordingly. \tKeep written batch records of raw materials where necessary. This information must be recorded for all batches mixed. \tUtilize computers to print raw material labels, weigh labels, and formula labels. \tMaintain production flow between spice room and mixers. \tScale up various raw material ingredients to specified quantities. \tKeep allergens separate and follow allergen tools color code. \tMaintain location accuracy for all raw materials in the spice room and staging areas. \tIssue all raw materials to specified mixing locations. \tCheck all expiration dates and use FIFO for all raw materials. \tReturn all raw materials that are not going to be used to return location. \tMaintain a clean and organized spiced room environment. \tUse of half face or full-face respirator \tWill require GMP clothing such as steel toe shoes, lab jacket, glasses, hairnets, beard guard and earplugs. Qualifications/skills \tAble to lift and pour 50 lbs. unassisted. \tReading / writing (record keeping). \tBasic mathematical ability (operate scale, read formulas, count, etc.). \tAbility to communicate using spoken words. Ability to communicate in English with co-workers in a respectful manner. \tExperience with scales and handheld scanners. \tUnderstand the difference between Gram, Ounce, and Pounds. \tAbility to use a calculator for simple addition and multiplication. \tTeam-work oriented; self-starter; dependable; responsible; attention to detail. \tUse of Electric jacks and Manual jacks. \tAbility to work in an alert and safe manner. \tAbility to work overtime as needed. \tHigh school diploma or equivalent. \tExperience preferred in a food manufacturing production environment. PHYSICAL DEMANDS \tMust be able to physically perform the functions of stooping, kneeling, crouching, reaching, standing, and walking for long periods of time, pushing, pulling, lifting, grasping, feeling, talking, hearing, and repetitive motions. \tMust be able to see in color. \tMust be able to lift and carry up to 50 pounds. 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. $17.00 - $17.00 Hourly

We are a specialized engineering company with international exposure and subject matter expertise in the design, fabrication and qualification of sterile, high purity and potent containment process equipment and plants. We are growing our company size and capabilities through recruitment of talented professionals. We offer a true creative engineering design work environment with a wide range of interesting projects in the bio-pharmaceutical, personal care and food industry. POSITION: You will be part of a cross-functional engineering team in the role of Jr. Process Engineer. You will develop and deliver conceptual, preliminary, and detailed design packages through to CQV for GMP-compliant integrated process equipment and unit operations used in the manufacturing of pharmaceutical drug substances and products. SUMMARY: Working under the guidance of a senior engineer you will be responsible for: • Design Basis Development, • Process Alternatives Evaluations, • User Requirement Specifications (URS), • Process Flow Diagrams (PFDs), • Process Piping and Instrumentation Diagrams (P&IDs), • Process Integration of Unit Operations, • Equipment Plot Plans and Layout Drawings, • Equipment Sizing and Specification, • Commissioning & Qualification Protocol Development and Execution SKILLS: • Strong interpersonal skills and the ability to work in a team environment., • Ability to manage and coordinate cross-functional project teams., • Ability to prioritize multiple tasks., • Self-directed, resourceful, and able to work independently with minimal oversight., • Excellent written and verbal communication skills., • Ability to work effectively in a fast-paced multi-tasking environment. EDUCATION: Bachelor’s degree in engineering LOCATION: The primary work location will be in our New Jersey site. However, a significant aspect of the role will involve intermittent international travel, including extended periods spent at equipment vendors for Factory Acceptance Tests (FATs) and at the client's site for Commissioning, Qualification, and Validation (CQV) activities. **APPLICATION INSTRUCTIONS: Please attach a single merged PDF and include both your resume and your unofficial transcript.

Our pharmaceutical client is looking for a chemist II to join their growing organization! If you are someone who wants to be a part of a highly technical team, this may be the role for you! The Chemist II/III will conduct release and stability testing for pharmaceutical products with specific focus on LC and GC chromatographic analyses as well as dissolution testing. This position involves conducting various analytical tests to ensure the quality and performance of solid dosage forms while maintaining a high level of laboratory safety and compliance. Key Responsibilities: • Prepare solid dosage samples for analysis by accurately weighing, blending, and homogenizing materials to ensure representative samples for testing., • Conduct dissolution testing of solid oral drug products using USP Apparatus I and Apparatus II., • Perform HPLC assays for the quantitative analysis of pharmaceutical components, including potency, purity, and samples from dissolution testing., • Ensure analytical instrumentation is properly maintained., • Ensure that all laboratory work complies with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP), following established Standard Operating Procedures (SOPs)., • Maintain accurate and detailed records of experiments, results, and procedures in laboratory notebooks and electronic systems, ensuring data integrity., • Adhere to safety protocols and participate in laboratory safety initiatives, ensuring a safe and compliant work environment. Minimum Qualifications: • Bachelor’s degree in chemistry with at least two (2) years of experience in the pharmaceutical industry., • Hands-on experience with HPLC, GC, Dissolution, and use of Empower software, • Strong analytical and problem-solving skills., • Excellent communication and teamwork skills., • Attention to detail and commitment to maintaining data integrity.

Company: David creates tools to increase muscle and decrease fat. Our first product is a protein bar. More broadly, David is a platform to develop high-protein, low-calorie, blood-sugar-friendly foods that are craveable. This is a compelling opportunity to be a part of an exciting new food brand as we operate within a critical growth stage. David is led by CEO Peter Rahal, the Cofounder and Former CEO of RXBAR ($600M exit to Kellogg in 2017). We have strong aspirations to become the most popular high-protein bar in North America and beyond. Role: We’re looking for a Laboratory Technician to support product development and food science initiatives across our portfolio. You’ll play a critical role in the day-to-day operations of the lab, including preparing and organizing experiments, tracking data, and helping scale new food technologies. This is a hands-on role. Most of your time will be spent in the lab preparing formulations, running tests, documenting results, and maintaining lab readiness. You’ll work closely with our R&D and Supply Chain teams to ensure high-quality execution and speed in innovation. Responsibilities: Benchtop Product Development: • Independently execute experiments, including ingredient weigh-up and product formation., • Provide accurate and detailed records of experimental outcomes. With the support of the R&D manager, interpret data from experiments and determine next steps., • Execute multiple work streams and project-related activities. Data Collection: • Conduct laboratory tests and take measurements on benchtop prototypes to ensure optimal quality and taste., • Support weekly shelf life evaluation via sensory analysis to ensure in-market product meets quality standards. Lab Management: • Ensure a clean and organized lab space to uphold a safe working environment. This includes cleaning, maintenance of workspace, and dishwashing., • Maintain a detailed inventory and updated stock of laboratory ingredients and equipment. What you’ll bring: Preferred but not required: • Familiarity with kitchen equipment including scales and mixers., • Experience with laboratory product development (food preferred)., • Knowledge of food safety regulations and standards (GMP, FDA)., • Required:, • High character and trustworthy., • Able and eager to learn how to operate equipment and contribute to product development., • The ability to operate independently while clearly communicating results to the rest of the team., • A self-starting attitude with a love for executing on ideas and moving quickly., • Humble, self-aware, and curious., • A desire to work for an early-stage CPG company with a mission to help people increase muscle and decrease fat. Practicalities: • This is a full-time, in-office role based in New York City. We work onsite five days a week — when the culture fits, it is fun to be in the office together., • Salary: $50 - $70K per year, • 100% covered Health, Vision, Dental Insurance., • 401(k) with 4% match., • Additional perks, such as covered gym expenses., • Substantial and required PTO. Application Process: • Applications will be evaluated on a rolling basis., • The target start date for this role is August 2025.

Job Description Role and Responsibilities Performs final assembly, finishing and/or testing of GPR product in the Assembly & Test Department at Daniel Road location as assigned. Key duties/responsibilities of Assembly & Test Technician, including, but not limited to: • Prioritizing of incoming work in order to maintain production delivery schedule, • Perform final cleaning operations on finished product, as assigned, per GPR standards/procedures, • Perform final assembly operations, as assigned, per issued traveler requirements and customer engineering documentation., • Perform final testing on finished product, as assigned, per GPR standards/procedures and customer engineering documentation., • Inspects work in progress to verify compliance with customer and company standards. Must identify nonconformances witnessed on product processed and report the same to the Assembly & Test Manager for disposition., • Verify all assembly, finishing and test requirements have been completed prior to product sign-off., • Maintain test records of leak testing and hydrostatic testing, • Maintain effective implementation of quality management system procedures and work instructions applicable to the Assembly & Test Department, as defined by GPR QMS, • Work together with engineering, production and quality management to ensure product meets customer and GPR quality expectations, • Keep accurate time and process records via ERP system., • Demonstrate practical knowledge of Good Machining Practices (GMP), • Be respectful and a team player with co-workers., • Maintain and provide support to all 5-S program initiatives. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Qualifications and Education Requirements Minimum Education: • Minimum 3 to 5 years’ experience in an assembly & test environment., • Must be able to interpret customer engineering specifications and/or drawings to determine product and quality requirements., • Should have strong documentation skills., • Excellent organizer with ability to read, write and speak fluent English Ability to understand and speak English. Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from supervisors, managers, clients, customers, and the general public. Mathematical Skills Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and basic trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Reasoning Ability Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of instructions furnished in written, oral, diagram or schedule form, and deal with several abstract and concrete variables. Physical demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to reach with hands and arms; and talk or hear. The employee is regularly required to stand; walk; sit; and use hands or fingers, handle or feel. The employee is frequently required to stand and work, lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, depth perception, color vision and the ability to adjust focus. Work environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate and sometimes loud. MUST HAVE • Basic mechanical skills, • Be able to use intermediate hand tools., • Computer proficient [ Excel, Word ], • Understanding in reading a blueprint, • Motivated, dependable….and most importantly Accountable

POSITION SUMMARY: Analytical Chemist will be engaged in the different laboratory testing using a range of analytical equipment and techniques within GMP laboratory. MAJOR DUTIES/RESPONSIBILITIES: • Perform assigned testing including but not limited to the physical, chemical tests per in-house written procedures and compendial monograph for the raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemistry, physical and instrumental techniques such as LC, GC, UV-Vis Spectrophotometer, dissolution, IR, Particle Size Analyzer, KF Auto titrator, Bulk Density, and other routine QC instruments., • Document work clearly and perform tests accurately. Record data and results as specified in documentation procedures., • Maintain proper laboratory logbooks, notebooks and other records all the time. Report and participate in the deviations and investigations. · Perform laboratory related other duties as assigned. MINIMUM/PREFERRED REQUIREMENTS: Education: Bachelor’s Degree in Science/Chemistry Experience: Based on the position level, must require minimum 2-10 years prior experience working in the Quality Control Laboratory in a cGMP environment, preferably in pharmaceutical industry. Hands on Empower-3 experience is plus. QC experience in Generic Pharmaceutical industries would be preferable Knowledge in Good Documentation practices. Knowledge in USP/ FDA BENEFITS: Offers a comprehensive benefits package to employees