Pharmaceutical compliance jobs in Passaic, New Jersey - Page 2Create job alerts

Job DescriptionBenefits: Position Type: Full-Time (Immediate Joining Preferred and Available to work weekends) Job Description: Icare Pharmacy Plus is seeking a dedicated and highly skilled Pharmacist to join our team. We are looking for a professional who can dispense medications accurately, provide excellent pharmaceutical care, and ensure compliance with all relevant laws and regulations. If you are motivated and committed to excellence in patient care, we encourage you to apply. Candidates available for immediate joining are preferred. Key Responsibilities: • Medication Dispensing: Accurately dispense prescription medications to patients., • Patient Counseling: Provide detailed counseling on medication usage, potential side effects, and interactions., • Regulatory Compliance: Ensure adherence to federal, state, and local pharmacy regulations., • Controlled Substances Management: Maintain accurate records and manage controlled substances responsibly., • Staff Training: Oversee and train pharmacy staff to ensure adherence to best practices., • Collaborative Care: Work with healthcare providers to manage and improve patient care., • Inventory Management: Maintain optimal inventory levels to prevent shortages and overstock., • Insurance Processing: Handle insurance claims processing and reimbursement efficiently., • Customer Service: Address and resolve patient inquiries and concerns professionally. Job Requirements: • Must Have: A valid state required pharmacist license, • Must Have: Doctor of Pharmacy (Pharm.D.) degree from an accredited institution., • Preferred: Minimum of 3-5 years of experience in a pharmacy setting. Skills: • Strong knowledge of federal and state pharmacy laws and regulations., • Proficiency with pharmacy management software systems., • Excellent communication and interpersonal skills., • Ability to work efficiently in a fast-paced environment., • Strong attention to detail and organizational skills., • Commitment to providing exceptional patient care. Preferred Qualifications: • Certification in Medication Therapy Management (MTM)., • Experience with inventory management and cost-saving measures., • Proven track record of effectively managing a pharmacy team. Benefits: • Performance-based bonus, • Competitive salary, • Paid time off, • Training and development opportunities, • Wellness resources Why Join Us: • Supportive Environment: Be part of a team that values and supports your contributions., • Growth Opportunities: Advance your career with opportunities for professional development., • Balanced Schedule: Maintain a healthy work-life balance with our balanced work schedules., • Competitive Packages: Benefit from competitive salary packages and growth opportunities. We look forward to reviewing your application. Icare Pharmacy Plus is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Job Description Company Overview: BioMatrix is a nationwide, independently-owned infusion pharmacy with decades of experience supporting patients on specialty medication. Our compassionate care team helps patients navigate the often-challenging healthcare environment. We treat our patients like family and get them started on therapy quickly. We work closely with them as well as their family and their healthcare providers throughout the patient journey, staying focused on optimal clinical outcomes. At BioMatrix the heart of our Inclusion, Diversity, Equity, & Access (IDEA) philosophy is the commitment to cultivate a welcoming space where everyone’s contributions are acknowledged and celebrated. Our goal is to draw in, develop, engage, and retain talented, high-performing individuals from diverse backgrounds and viewpoints. We believe that both respecting and embracing diversity enriches the experiences and successes of our patients, employees, and partners. Pharmacist License Needed: New Jersey Schedule & Location: It is anticipated that an incumbent in this role will work on-site in our Totowa, NJ location. It is anticipated that an incumbent in this role will work Monday through Friday from 8:30am Eastern Standard Time To 5pm Eastern Standard Time. Work location and schedule are subject to change based on business needs. The Pharmacist-in-Charge is a licensed professional who is responsible for providing safe and appropriate pharmacy services to BioMatrix patients in accordance with the policies and procedures of the, BioMatrix, pharmacy practice professional standards, and applicable regulatory entities. The Pharmacist coordinates patient services with the Nursing Department, monitors patient progress toward goals and educates patients, caregivers, staff and other professionals regarding appropriate medication use. The Pharmacist-in-Charge performs specified distributive and clinical pharmacy activities and related services as they pertain to the quality care of the parenteral infusion therapy/ specialty pharmacy patient. The pharmacist will perform additional pharmacy operation responsibilities as assigned by the Associate Director of Pharmacy Services or VP of Infusion Pharmacy Services. QUALIFICATION REQUIREMENTS • Doctor of Pharmacy degree is preferred or Bachelor of Science degree from an ACPE accredited School of Pharmacy., • At least 3 years pharmacy experience and knowledge of one or more of the following specialty pharmacy, infusion pharmacy (sterile, non-sterile, hazardous, non-hazardous compounding)., • A pharmacist license in good standing with the Board of Pharmacy in the state pharmacy resides in at a minimum, multiple licenses are preferred., • A current, unrestricted, in good standing Pharmacy license as granted by the Board of Pharmacy., • A minimum of one to two years home infusion therapy, specialty pharmacy experience or minimum of 2 years clinical hospital experience in compounding (non-hazardous, hazardous, sterile, non-sterile), transplant, Hepatitis C, hemophilia, multiple sclerosis, neurology, immunology, rheumatoid arthritis/psoriasis, Crohn’s/ulcerative colitis nutritional support, oncology, and infectious disease., • Experience providing customer service to internal and external customers, including meeting quality standards for services, and evaluation of customer satisfaction., • Basic level skill in Microsoft Office (including Word, Excel, PowerPoint, etc.)., • Completion of a Post Graduate residency program preferred but not required, • At least 3 years of experience in home care, specialty pharmacy or hospital setting., • Maintains policies and other standards established by the pharmacy., • Performs initial patient evaluation and reassessments as it pertains to the following:, • Assumes delegated responsibilities for the management of drug therapies., • Collects, analyzes, interprets and evaluates appropriate data necessary to identify the patient's drug therapy needs, drug interactions, unusual doses, allergies, adverse reactions/side effects, response to therapy, compliance to therapy, etc., • Obtains histories and applies these theories with those taken by others and other patient data to optimize drug therapy management., • Sets therapeutics objectives and monitors patients for desired therapeutic response in order to design and utilize acceptable drug therapy management., • Interprets data for objective assessment of physiological functions in order to monitor the effects of drug therapy., • Evaluates the significance of signs or symptoms related to certain disease processes to make recommendations for the modification of drug therapy to these problems and to contribute to their prevention., • Assists the referring physician and institution in planning and implementing patient care to ensure a smooth transition from the hospital to the home., • Assists home patients in the self-management of home infusion/specialty pharmacy therapy., • Conducts patient calls to perform any patient assessments., • Provides counseling and answers questions from patients, family and health care professionals concerning the drug therapy., • Assists in the evaluation and management of problems, which may arise due to the psychological, social and economic aspects of therapies., • Maintains thorough and appropriate documentation in the patient's medical records of all communications and telephone contacts with the patient and their physician., • Prepares progress reports for the referring physicians, insurance provider and others when needed., • Supervises or directly compounds and dispenses pharmaceuticals and related ancillary supplies in accordance with federal, state and local laws and standards of practices within the profession., • Processes and checks all medications, supplies, and equipment prior to dispensing from the pharmacy., • Assists in purchasing, receiving, inventorying and storing of pharmaceuticals., • Assists in special projects and clinical research as directed., • Maintains proficiency in the skills and theory of home infusion and specialty pharmacy therapies by reviewing the literature and attending in-services, seminars, and conferences., • Participates in "on-call” rotation., • Participates in quality assurance activities and audits as directed., • Performs related duties as requested., • Experience and a strong knowledge base in intravenous admixture., • Must be capable of assuming responsibilities in the monitoring and management of nutritional support and drug therapy relative to the total needs of the home care patient in collaboration with physicians, nurses, and other health care professionals., • Must be flexible with work schedules including on-call coverage., • Must be capable of assuming responsibilities in the monitoring and management of nutritional support and drug therapy relative to the total needs of the home care patient in collaboration with physicians, nurses, and other health care professionals., • Experience and a strong knowledge base in intravenous admixture., • Participation and membership in professional societies and organizations is desirable., • Knowledge of the principles and practices involved in compounding and dispensing of prescriptions., • Knowledge of pharmacy, drug, narcotic, and related laws and regulations of the state board of pharmacy and respective prescription monitoring programs, along with federal laws and accreditation standards., • Knowledge of pharmaceuticals, drugs, narcotics, and poisons., • Knowledge of the calculation of doses and the preparation and use of percentage and stock solutions., • Knowledge of the basic sciences underlying pharmacy, such as chemistry, biology, and physics., • Knowledge of the processes involved in the manufacture of pharmaceutical preparations., • Knowledge of stock control and related record keeping., • Ability to apply safety and efficiency in the prescribing, dispensing, administering, and use of drugs and related articles for the prevention of illness and the maintenance and management of health., • Ability to fill prescriptions and prepare official drugs and standard medications., • Ability to recognize physical, chemical, and therapeutic incompatibilities., • Ability to analyze and understand Physicians' or other recognized, medical personnel's oral or written orders involving standard symbols and terminology., • Ability to apply pharmaceutical laboratory techniques., • Ability to maintain accurate records and prepare reports and correspondence related to the work., • Ability to maintain favorable public relations., • Ability to organize and coordinate the work of others., • Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings., • This position requires constant sitting with occasional walking, standing, kneeling or stooping., • This position requires the use of hands to fingers, handle or feel objects and the ability to reach with hands and arms., • This position requires constant talking and listening., • Specific vision abilities required by this job include close vision and the ability to adjust focus., • Will participate in legal and ethical compliance training each year., • Will consistently behave in compliance with the BioMatrix legal and ethical policies and procedures., • Will abide by the policies of BioMatrix as set forth in the Compliance Manual., • Will not participate in any conduct considered to be unethical or illegal. EXPECTATION FOR ALL EMPLOYEES Supports the organization's mission, vision, and values by exhibiting the following behaviors: excellence and competence, collaboration, innovation, respect personalization, commitment to our community, and accountability and ownership. GENERAL INFORMATION: The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and skills required of personnel so classified. The incumbent must be able to work in a fast-paced environment with demonstrated ability to juggle and prioritize multiple, competing tasks and demands and to seek supervisory assistance as appropriate. Incumbents within this position may be required to assist or find appropriate assistance to make accommodations for disabled individuals in order to ensure access to the organization's services (may include: visitors, patients, employees, or others).

Job DescriptionBenefits: • 401(k), • Competitive salary, • Flexible schedule, • Opportunity for advancement, • Paid time off, • Training & development Position Type: Full-Time (Immediate Joining Preferred and Available to work weekends) Job Description: Icare Pharmacy Plus is seeking a dedicated and highly skilled Pharmacist to join our team. We are looking for a professional who can dispense medications accurately, provide excellent pharmaceutical care, and ensure compliance with all relevant laws and regulations. If you are motivated and committed to excellence in patient care, we encourage you to apply. Candidates available for immediate joining are preferred. Key Responsibilities: • Medication Dispensing: Accurately dispense prescription medications to patients., • Patient Counseling: Provide detailed counseling on medication usage, potential side effects, and interactions., • Regulatory Compliance: Ensure adherence to federal, state, and local pharmacy regulations., • Controlled Substances Management: Maintain accurate records and manage controlled substances responsibly., • Staff Training: Oversee and train pharmacy staff to ensure adherence to best practices., • Collaborative Care: Work with healthcare providers to manage and improve patient care., • Inventory Management: Maintain optimal inventory levels to prevent shortages and overstock., • Insurance Processing: Handle insurance claims processing and reimbursement efficiently., • Customer Service: Address and resolve patient inquiries and concerns professionally. Job Requirements: • Must Have: A valid state required pharmacist license, • Must Have: Doctor of Pharmacy (Pharm.D.) degree from an accredited institution., • Preferred: Minimum of 3-5 years of experience in a pharmacy setting. Skills: • Strong knowledge of federal and state pharmacy laws and regulations., • Proficiency with pharmacy management software systems., • Excellent communication and interpersonal skills., • Ability to work efficiently in a fast-paced environment., • Strong attention to detail and organizational skills., • Commitment to providing exceptional patient care. Preferred Qualifications: • Certification in Medication Therapy Management (MTM)., • Experience with inventory management and cost-saving measures., • Proven track record of effectively managing a pharmacy team. Benefits: • Performance-based bonus, • Competitive salary, • Paid time off, • Training and development opportunities, • Wellness resources Why Join Us: • Supportive Environment: Be part of a team that values and supports your contributions., • Growth Opportunities: Advance your career with opportunities for professional development., • Balanced Schedule: Maintain a healthy work-life balance with our balanced work schedules., • Competitive Packages: Benefit from competitive salary packages and growth opportunities. We look forward to reviewing your application. Icare Pharmacy Plus is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Job DescriptionBenefits: • 401(k), • Competitive salary, • Flexible schedule, • Opportunity for advancement, • Paid time off, • Training & development Pharmacy Name: Presidential Pharmacy Location: 121 W Broadway, Paterson, NJ - 07522 Position Type: Full-Time Immediate Start Preferred Company Overview: Presidential Pharmacy is looking for a dedicated and experienced Pharmacist to join our team. We are committed to delivering exceptional patient care and ensuring that our pharmacy operates in full compliance with all relevant laws and regulations. If you are passionate about pharmaceutical care and ready to make a difference, we invite you to apply. Candidates available for immediate start are preferred. Key Responsibilities: • Medication Dispensing: Accurately dispense prescription medications to patients., • Patient Counseling: Provide thorough guidance on medication usage, potential side effects, and interactions., • Regulatory Compliance: Ensure compliance with federal, state, and local pharmacy regulations., • Controlled Substances Management: Maintain precise records and responsibly manage controlled substances., • Staff Training: Train and mentor pharmacy staff to uphold best practices., • Collaborative Care: Collaborate with healthcare providers to enhance patient care., • Inventory Management: Monitor and manage inventory levels to avoid shortages or excess., • Insurance Processing: Efficiently handle insurance claims and reimbursements., • Customer Service: Professionally address and resolve patient inquiries and concerns.Job Requirements:, • Required: Valid pharmacist license as per state regulations., • Required: Doctor of Pharmacy (Pharm.D.) degree from an accredited institution., • Preferred: 3-5 years of experience in a pharmacy setting.Skills:, • In-depth knowledge of federal and state pharmacy laws and regulations., • Proficiency in pharmacy management software., • Excellent communication and interpersonal abilities., • Strong organizational skills with a keen attention to detail., • Ability to thrive in a fast-paced environment., • Dedication to providing outstanding patient care.Preferred Qualifications:, • Certification in Medication Therapy Management (MTM)., • Experience in inventory management and implementing cost-saving measures., • Proven success in managing a pharmacy team effectively.Benefits:, • 401(k) matching, • Performance-based bonuses, • Competitive salary, • Paid time off, • Opportunities for training and professional development, • Wellness resourcesPerks:, • Competitive Compensation: Attractive salary and benefits packages., • Supportive Environment: Work within a collaborative team that values your contributions., • Career Advancement: Opportunities for growth and development within the organization., • Work-Life Balance: Flexible schedules to support a healthy work-life balance.Why Join Us?, • Supportive Environment: Be part of a team that values your input and fosters your growth., • Growth Opportunities: Advance your career with ample professional development options., • Balanced Schedule: Enjoy a healthy work-life balance with our flexible schedules., • Competitive Packages: Benefit from attractive compensation and growth potential.We look forward to receiving your application! Presidential Pharmacy is an equal opportunity employer. We celebrate diversity and are committed to fostering an inclusive environment for all employees.

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 DescriptionQuality Assurance Manager - ValidationAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. This position will report into the Associate Director of Quality Assurance responsible for the oversight and management of Quality Assurance Validation/Qualification activity. Responsible for managing the quality assurance validation activity such as development, implementation, and continuous improvement initiatives at two Allendale, NJ manufacturing sites. This role works to build, enhance, harmonize and manage quality assurance validation across sites and is responsible for finding solutions and coordinating change initiatives. Core responsibilities include, but not limited to, document management: review and approval of validation protocol, report, investigation report, assignment of CAPA, SOP development and revisions. Provides cross departmental support within Quality Assurance, as well as, collaborates with other Quality departments to support organizational and functional strategy. Develops and/or revises policies and procedures, as well as, supports operational excellence initiatives. Represents Quality Compliance in internal and external audits which may include interaction with regulatory health authorities and clients. • Functions as the sites Quality Assurance validation partner ensuring quality standards are enforced., • Partners closely with quality training staff in development of learning curriculum that drives compliance standards., • Oversees and manages the activities of validation team; provides leadership and direction to ensure that organizational and departmental goals are met., • Coordinates the investigation and closure of deviations with root cause analysis., • Ensures appropriate Corrective and Preventive Actions (CAPA) are initiated, implemented., • Manages end-to-end delivery of quality document assuring compliance of company's quality standards., • Reviews and approves GMP documents such as investigation report, CAPA, validation protocols and reports, SOPs, change controls, etc., • Reviews and proposes changes to quality agreements., • Participates in ongoing quality system improvement programs and initiatives. Establishes Quality Validation KPI Reporting and Continuous Improvement metrics., • Participates in internal audits, regulatory agencies, and client audits., • Provides technical information during tech transfer activities to ensure all quality requirements are met according to current industry standard., • Establishes departmental KPIs in alignment with organizational goals and objectives., • Plans and allocates resources to effectively staff and accomplish the work to meet departmental productivity and quality goals., • Plans, evaluates, and improves the efficiency of business processes and procedures to enhance speed, quality, efficiency, and output., • Makes business decisions that are financially responsible, accountable, justifiable, and defensible in accordance with organization policies and procedures., • Establishes and maintains relevant controls and feedback systems to monitor the operation of the department., • Determines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees., • Provides oversight and direction to the employees in accordance with the organization's policies and procedures., • Coaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities., • Empowers employees to take responsibility for their jobs and goals. Delegates responsibility and holds staff accountable by providing regular feedback., • Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise., • Creates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization., • Leads employees to meet the organization's expectations for productivity, quality, continuous improvement, and goal accomplishment., • Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning., • Provides effective performance feedback through employee recognition, rewards, and disciplinary action, with the assistance of Human Resources, as necessary., • Maintains employee work schedules including assignments, job rotation, training, vacations and paid time off, coverage for absenteeism, and overtime scheduling., • Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, Instant Messaging (IM), and regular interpersonal communication., • Supervise 1-2 Direct Reports, • Other duties as assigned.REQUIRMENTS, • Bachelor of Science in biological sciences or other relevant field of study., • 5-10 years’ relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments. 3+ years of recent supervisory experience required. Experience in both clinical and commercial manufacturing is preferred., • Knowledge of FDA and EMEA regulations and a working knowledge of root cause analysis., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (investigation, validation/qualification reports, SOPs etc.), • Experience in organizing and leading teams., • Experience participating in health authority inspections and/or client audits., • 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., • Training; GXP, SOP & WI training, Safety, • Must be able adaptable, collaborative, accountable, and have a “can-do” pioneering spirit., • Must be able to foster and work in a team-oriented environment., • Must be able to work infrequently on 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.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 DescriptionSupplier Quality AuditorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Supplier Quality Auditor ensures and promotes compliance through external auditing of company's suppliers; vendors/ laboratory services/service providers/manufacturers for the Allendale, NJ and Mountain View, CA sites based on company's procedures and external regulatory requirements, including but not limited to current FDA Quality System Regulations; 21 CFR Parts 210/211 (cGMP), 21 CFR Part 1271 (GTP), 21 CFR Parts 50/54/56/312 (GCP), 21 CFR Pat 58 (GLP), ICH Q7, Q9, Q10, 21 CFR Part 11 and Data Integrity and Eudralex Volume 4 Guidelines.The Supplier Quality Auditor position will be responsible for the development of a risk-based auditing program for company and management of the Approved Supplier List. The Supplier Quality Auditor will conduct external supplier/vendor/manufacturer audits and harmonize the supplier qualification process across all sites. The Supplier Quality Auditor supports qualification initiatives, continuous improvement, and regulatory compliance across all sites. • Develop and maintain a risk-based external auditing program for company harmonized across all sites., • Perform GAP analyses of the Approved Supplier List (ASL) of suppliers used at all company facilities to ensure complete profile., • Management of ASL to add suppliers and maintain approval status of all suppliers as needed., • Based on ASL status, conduct reviews and perform audits to qualify each supplier used., • Prepare external audit schedule and conduct audits per the schedule., • Prepare and complete audit reports and communicate audit information to cross functional teams within company and supplier within a timely manner., • Ensure adequate CAPAs are developed by suppliers and monitor CAPA closures., • Track audit findings for suppliers to completion and ensure timely closure of audit reports., • Act as a quality lead and liaison between suppliers and internal teams to identify new suppliers and identify and communicate issues that may impact quality, system gaps or cause interruptions in business continuity., • Maintain metrics on supplier audit findings used for oversight, qualification status, continuous improvement, and/or opportunities for reduction/alternate suppliers., • Maintain audit files and ensure all files are properly archived., • Author and review External Auditing, Supplier Qualification and Supplier Management Program and/or Quality Systems SOPs, as needed., • Ensure that Quality Agreements are generated and enforced at each supplier., • Ensure and promote compliance with applicable regulations (e.g., cGMPs, GTPs, etc.) and company and client SOPs., • Assist in other Quality System related responsibilities and provide Quality related support to various departments, as needed.REQUIREMENTS, • Minimum 5-8 years quality systems auditing experience in pharmaceutical, biologics, or medical device industry., • Auditor qualifications and certifications such as Certified Quality Auditor (CQA)/ASQ Certification, ISO Certification, etc., • Experience with auditing raw materials/excipients, components, and analytical and micro laboratories., • Proven ability to identify, collaborate, and resolve supplier related compliance issues., • In-depth knowledge and understanding of current Good Manufacturing Practices (cGMPs), Good Laboratory Practices (GLPs), ICH Q10, 21 CFR Part 11, Good Tissue Practices (GTPs) and Data Integrity principles,, • EU and PMDA regulations knowledge and associated guidelines are a plus., • Bachelor’s Degree in the chemistry or biological sciences, engineering, or life sciences., • Certified Auditor or Lead Auditor credentials required., • Understanding of the manufacture and testing of cellular and gene therapies is desirable., • Working knowledge of routine laboratory operations, equipment and systems, production processes, and validation., • Experience in Quality Assurance, including the ability to identify and resolve compliance issues., • Sound knowledge of aseptic processing and supporting technologies., • Must have exceptional written and oral communication skills., • Exhibit professional mannerisms when dealing with Clients/Suppliers and company personnel, • Ability to multi-task is essential., • Proficiency with IT skills, such as MS Office (Word, Excel, Outlook, PowerPoint) and SharePoint., • Ability to think strategically and tactically (strong detail-oriented)., • Strong collaborative and influencing skills and ability to work well in a cross-functional, team matrixed environment as well as independent contributor., • Strong analytical and problem-solving skills., • Flexible and able to adapt to company growth and evolving responsibilities., • Multi-disciplinary knowledge across GxP functional areas., • Excellent organizational skills including efficiency, punctuality and attention to detail and managing multiple priorities., • Good verbal, written communication, and presentation skills., • Demonstrable multitasking, project management, and execution skills., • Good business acumen and strong team-oriented interpersonal skills, including communication, presentation, negotiation, influence., • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors., • Must have the ability to work in a team-oriented environment and with clients, • Must be able to handle the standard/moderate noise of the manufacturing facility, • Travel required (approx. 50%)Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Job DescriptionHuman Resources Business PartnerAllendale, NJLynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. Our Biotechnology client located in Allendale, NJ is seeking a Human Resources Business Partner who will provide human resources consultation and support to the Quality Department. This position is both operational and strategic in nature and provides HR expertise in the areas of talent management, organization design and effectiveness, performance management, employee relations, employee engagement, compensation, retention and process improvement initiatives. This role reports to the Sr. Director, Human Resources and will serve as a business partner to the Quality Leadership team and function. In addition, this role supports, implements, and executes all tactical aspects of the HR function. • Understand business needs in order to assess the HR implications of various business strategies., • Act as liaison to other functions to ensure achievement of business objectives., • Provide staffing and placement support to departments and divisions., • Facilitate the recruitment and on-boarding process for all new hires.HR Leadership: Coaching, developing and providing guidance to HR team members within assigned groups.Business Partner: Serving as a true business partner and advisor, gaining the trust of the organization in order to influence and provide effective HR processes, advice and support.Talent Acquisition: Designing and executing workforce planning and recruitment strategies that attract and retain the best talent in the industry.Organization Effectiveness: Serves as a change agent in the organization, sponsoring change initiatives in support of organizational evolution.Employee Relations: Promoting a philosophy of employee relations throughout the company which emphasizes open communications, equal opportunities and treatment, continuous learning and reflects our core values.HR SME: Acting as a subject matter expert within the organization and providing interpretation, recommended best practices and ensures compliance with key legal requirements and adherence to company policies and procedures.Compensation: Ensures our compensation practices continue to attract and reward top talent. Oversee the salary administration to include annual performance management and compensation processes.Continuous Improvement: Analyzing trends and metrics in partnership with the HR team to draw insights, develop solutions, programs and policies. REQUIREMENTS, • Bachelor’s degree in business, Human Resources or related field., • Minimum of ten years progressive HR/business leadership experience is required., • Demonstrated ability to build credibility and confidence with a wide variety of employees and leaders as a trusted advisor and confidant., • Ability to influence individuals at all levels of the organization., • Strong problem solving and conflict resolution skills., • HR Certification (PHR, SHRM-CP) or ability to obtain certification within one year of employment., • Prior experience in working in a matrix and complex operating environment preferred. Fast paced, challenging industry, • Build strong relationships with peers and cross functionally with partners outside of team to enable higher performance., • Highly ethical, authentic and committed to high integrity., • Learns fast, while being adaptable to the changing environment., • Look to raise the bar of service delivery and always seeks ways to address the status quo looking for ways to improve., • Communication proficiency: for both written and verbal communication, • Work collaboratively with all levels of employees., • Flexibility and adaptable in a high pressured, clinical and/or pharmaceutical environment., • Work with a composed attitude and behaves accordingly., • Action oriented with results, executes on all assigned goals and objectives, • Must have high level of interpersonal skills to ensure accurate flow of all information.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 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 DescriptionHuman Resources ManagerAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Life Sciences, Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Human Resources Business Partner will provide human resources consultation and support to assigned divisions. Understand business needs in order to assess the human resources implications of various business strategies. Acts as liaison to other functions to ensure achievement of business objectives. Provides staffing and placement support to departments and divisions. Facilitates the recruitment and on-boarding process for all new hires. This position is both operational and strategic in nature and provides HR expertise in the areas of talent management, organization design and effectiveness, performance management, employee relations, employee engagement, compensation, retention and process improvement initiatives. This role will report to the Sr. Director, Human Resources and will serve as a business partner to the Quality Leadership team and function. In addition, this role supports, implements, and executes all tactical aspects of the HR function. • HR Leadership: Coaching, developing and providing guidance to HR team members within assigned groups., • Business Partner: Serving as a true business partner and advisor, gaining the trust of the organization in order to influence and provide effective HR processes, advice and support., • Talent Acquisition: Designing and executing workforce planning and recruitment strategies that attract and retain the best talent in the industry., • Organization Effectiveness: Serves as a change agent in the organization, sponsoring change initiatives in support of organizational evolution., • Employee Relations: Promoting a philosophy of employee relations throughout the company which emphasizes open communications, equal opportunities and treatment, continuous learning and reflects our core values., • HR Expert: Acting as a subject matter expert within the organization and providing interpretation, recommended best practices and ensures compliance with key legal requirements and adherence to company policies and procedures., • Compensation: Ensures our compensation practices continue to attract and reward top talent. Overseeing salary administration to include annual performance management and compensation processes., • Continuous Improvement: Analyzing trends and metrics in partnership with the HR team to draw insights, develop solutions, programs and policies.REQUIREMENTS, • Bachelor’s degree in business, Human Resources or related field., • HR Certification (PHR, SHRM-CP) or ability to obtain certification within one year of employment., • 10 + years progressive HR/business leadership experience is required., • 5+ years in clinical and/or pharmaceutical industry., • Demonstrated ability to build credibility and confidence with a wide variety of employees and leaders as a trusted advisor and confidant., • Ability to influence individuals at all levels of the organization., • Strong problem solving and conflict resolution skills., • Prior experience in working in a matrix and complex operating environment preferred. fast paced, challenging industry., • Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance., • Highly ethical, authentic and committed to high integrity., • Learns, fast, while being adaptable to the changing environment., • Looks to raise the bar of service delivery and always seeks ways to address the status quo looking for ways to improve., • Communications proficiency: for both written and verbal communication., • Works collaboratively with all levels of employees., • Works with a composed attitude and behaves accordingly., • Action oriented with results, executes on all assigned goals and objectives.

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

Job DescriptionCompany Description Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years. Job Description Electrical Factory Inspector (Remote/Travel) responsibilities include, but are not limited to, the following: • Support department objectives and company goals, • Be a team player, • Sustain a positive, enthusiastic and professional attitude at all times, • Accommodate requests with a smile and “let me see what I can do” attitude, • Adhere to manager directives, • Maintain a professional appearance and demeanor, • Arrive on time, properly dressed and prepared to work, • Perform all duties in a timely, accurate, honest and professional manner, • Communicate with customers professionally and in accordance with customer service standards, • Surveillance inspections of factories to assure products remain in compliance with conditions of granted certification., • Other duties assigned by management.Qualifications Basic Minimum Education Qualifications: • Knowledge of electronics, • Certification in Electronics, ideal but not required, • Willing to travel - This position requires 90% - 100% travel, • Able to rent a car, • Willing to work overtime and remote, • Cannot be on any no fly list, • Clean driver record, • Ability to maintain confidentially, • Needs to be receptive to and accepting guidance from others, • Ability to deal with difficult people and problems, • Able to work well in a team environment, • Able to work in a diverse group of people, • Attention to detail, • Ability to multi-task and prioritize assignments, • Able to sit or stand for long periods of time, • Able to lift up to 30 pounds Additional Information Position is full-time travel & hybrid, working Monday - Friday 8:00 am to 5:00 pm, with overtime as needed. • Compensation: $50,000 - $70,000, • Excellent full-time benefits including comprehensive medical coverage, dental, and vision options, • Life and disability insurance, • 401(k) with company match

Job DescriptionQuality Assurance Manager The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily tasks in support of corporate Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases as well as assists Quality management with department needs.The ideal candidate in this role, the Manager, Quality Assurance exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments. Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation. • The QA Manager will delegate responsibilities to direct reports (QA Associate I, II, and III) to achieve the requisite business needs, while providing ongoing support to Manufacturing processes., • Ensure the safe release of cellular products in accordance with HCATs and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Establish and maintain policy for documentation of all products and perform internal documentation audits., • Author and review relevant SOPs, validation and other documents., • Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review., • Control Master Batch Records, distribution and label verification., • Perform line clearance activities as required., • Assign and maintain product lot numbers as applicable., • Ensure materials management nonconformance disposition and release activity as applicable., • Ensure accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks., • Provide support to manufacturing for investigations of deviations, validations, and development of specifications, • Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements., • Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted., • Perform employee training on QSR and ISO requirements and company quality systems, • Perform document control activities as assigned., • Mentor/train/develop and manage Quality Assurance team., • Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality AgreementsREQUIREMENTS, • BS Degree in biological sciences or equivalent., • Minimum 5-10 years related experience in the pharmaceutical or biologics industry., • Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)., • Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc., • Sound knowledge of aseptic processing and supporting technologies., • Analytical and technical troubleshooting skills are a plus., • Proficient with Microsoft Office Suite., • Excellent organizational skills and attention to detail., • Good verbal and written communication skills., • Strong team-oriented interpersonal skills are essential., • Travel may be required, • Strong business acumen, • Experience 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, • Meeting management/facilitation skills/teamwork, • Ability to multi-task is essential, • Flexible and able to adapt to company growth and evolving responsibilitiesPlease 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 DescriptionQuality Assurance Associate IIIAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, SOPs, Qualification and Validation Reports; review of QC data; perform material releases and final product releases; review of Deviations as well as assists Quality management with department needs. He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. This role manages internal and external audits which may include interaction with Health Authorities and clients • Interfaces directly with client and cross functional teams, • Provides resolutions pertaining to quality for project related issues, • Independently prioritize, schedule, and manage multiple projects and resources (team), • Ensures the safe release of cellular products in accordance with company and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Able to provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Author and review relevant SOPs, validation and other documents., • Responsible for the timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Responsible for the completion of all client requirements related to cellular product and/or material releases., • Master Batch Record Control, distribution and label verification, • Perform line clearance activities as required., • Assignment and maintenance of product Lot numbers as applicable., • Perform internal documentation audits as assigned., • Materials management nonconformance disposition and release activity as applicable., • Responsible for accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Track and trend relevant quality metrics including environmental monitoring data., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Electronic Document Control activities as assigned., • Provide training to personnel as assigned by supervisor., • Travel may be required.REQUIREMENTS, • BS in biological sciences or other relevant field of study, • 5 years + experience in QA in a life sciences company company with a strong focus in the manufacturing and/or testing of biologics., • Working knowledge and technical understanding of aseptic manufacture of biologics, • Understanding of quality system applications, • Experience in both clinical and commercial manufacturing is preferred., • Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (validation/qualification reports, SOPS. Etc., • Experience in organizing teams for effective and timely completion of projects., • Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc., • Experience participating in or hosting health authority inspections and/or client audits., • Computer skills (Microsoft Office, Outlook), • Detail-oriented and organized, • Analytical and problem-solving skills, • Good written and oral communication skills, • Ability to multi-task and be adaptable, • Flexible and able to adapt to company growth and evolving responsibilities, • Ability to work independently and with a team, • Strong Project Management and organization skills, • Must 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 companyMay be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, etc. 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 DescriptionQuality Control Microbiology Engineer III Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT and Human Resources disciplines in New Jersey. The Quality Control Microbiology Engineer III will support two local sites. Serving as a support role to clinical and/or commercial production. The QC Microbiology Engineer III will coordinate data for batch release, participate in project/client meetings, and author/revise microbiological testing procedures. Additionally, the incumbent will perform microbiological testing including, but not limited to, growth promotion, microbial identification, sterility testing, Gram stain, and endotoxin. Under the direction of the Associate Manager of Microbiology, responsibilities of the • Documentation according to written Standard Operating Procedures in accordance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)., • Coordinates microbiological testing data for batch release, • Participation in project/client meetings and communications, providing scientific and technical expertise, • Authoring/revising Standard Operating Procedures, Work Instructions, Forms, and Protocols, • Review of investigations and documentation of non-confirming events and environmental excursions., • Apply expertise of compliance requirements to maintain an inspection-ready state., • Participate and act as subject matter expert during audits/inspections, • Develop and train QC Microbiology Engineer II on relevant business processes, • Processing of purchase orders for outsourced testing and lab supplies, • Coordinates work orders, • Other duties as assignedREQUIREMENTS, • BA/BS in a science or relevant field required or equivalent experience, • Minimum 5-7 years of experience with environmental monitoring or within the biopharmaceutical industry, • Minimum required training; GxP/GDP Training, Safety Training, • Proficient with computer software such as; Microsoft Office, MODA/LIMS; Microsoft Visio (preferred); Netsuite (preferred); Maximo Asset Management System (preferred), • Proficient knowledge of ISO and EU standards, • Strong knowledge of quality systems and ability to interpret Quality standards for implementation and review., • Strong written and oral communication skills, • Strong technical writing skills, • Technical training experienceMust 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 responsibilitiesSupervisory Responsibility; Direct reportsWhile 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.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, liquid nitrogen and noise levels.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.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.Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.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 work during the weekend, holidays and as required by the companyMust 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 DescriptionDescription: Under the direct supervision of the Chief Medical Officer, the Optometrist provides direct clinical care to patients at the health center. The Optometrist is a member of the Care Team with the purpose of providing evidenced-based and quality medical care to Zufall Health Center patients. Essential Functions, Duties, and Responsibilities • Provides eye care services for patients of Zufall Health, including but not limited to comprehensive eye examinations, diagnosis and management of ocular diseases, prescription of corrective lenses (if applicable), referral to ophthalmologists or other specialists when appropriate, and other duties as assigned. Ensures continuity and quality of patient care., • Leads and collaborates with assigned clinical support staff to deliver exceptional and accessible preventive, acute, and chronic eye care to a diverse patient population. Educates patients and families about eye health and vision care., • Participates in extended service hours including occasional evenings or weekends as scheduled. Adjusts availability as needed to support patient demand and clinic operations., • Assists patients in obtaining additional services such as low vision aids, specialty referrals, or surgical consultations. Works closely with the Chief Medical Officer to build relationships with external providers, optical labs, and vision care networks to enhance patient access and care coordination., • Participates in clinical quality improvement initiatives and peer chart reviews as assigned. Attends and contributes to regular medical staff and team meetings as deemed necessary by leadership., • Supports clinic operations by maintaining compliance with all applicable local, state, and federal regulations. Ensures that licensure, certifications, and continuing education requirements are current. Adheres to and helps refine clinical protocols and practice guidelines., • Participates in community outreach including vision screenings, health fairs, and educational workshops. Supports staff training, mentorship, and may precept optometry students or interns as needed., • Maintains professional affiliations and stays informed of advancements in optometric care, techniques, and public health concerns. To perform successfully, the individual must be able to perform the essential duties satisfactorily. The requirements below are representative of the knowledge, skill and ability required. • Doctor of Optometry (OD) degree from an accredited optometry school., • Strong verbal and written communication skills., • Ability to work effectively with a diverse range of patients and colleagues., • Flexibility and commitment to working variable hours as required to meet clinic needs., • Proficiency with EHR systems and general computer applications including Microsoft Word and Excel., • Bilingual and/or bicultural candidates are highly valued; ability to speak both English and Spanish strongly preferred., • Doctor of Optometry (OD) from a program accredited by the Accreditation Council on Optometric Education (ACOE)., • Active license to practice optometry in the state of New Jersey, in good standing., • Certification to use therapeutic pharmaceutical agents (TPA) as required by New Jersey regulations., • National Provider Identifier (NPI) and eligibility to participate in Medicare, Medicaid, and other health programs., • Current BLS certification; other certifications (e.g., Advanced Procedures, Low Vision) may be preferred depending on clinic scope., • Minimum 1 year of post-graduate clinical experience preferred; new graduates with strong clinical training may be considered.

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

Job Description Job Summary We are seeking a detail-oriented and tech-savvy Warehouse Inventory Specialist to support daily warehouse operations with a strong focus on inventory accuracy, order tracking, and system usage. This role is ideal for someone who is sharp, organized, and comfortable working with computer systems to manage inventory in a fast-paced biotech environment. Key Responsibilities • Maintain accurate inventory levels using warehouse management systems (WMS) and internal tracking software, • Receive, inspect, and record incoming materials and products, • Track inventory movement, lot numbers, and expiration dates to ensure compliance and traceability, • Process and verify outbound orders, ensuring accuracy and on-time fulfillment, • Perform cycle counts and assist with full physical inventory audits, • Investigate and resolve inventory discrepancies using system data and reports, • Generate inventory reports and update records in real time, • Follow SOPs, safety guidelines, and quality standards required in a biotech/regulated environment, • Coordinate with warehouse, operations, and quality teams to support smooth workflows Qualifications • Previous warehouse or inventory experience preferred (biotech, pharmaceutical, or regulated environment a plus), • Strong computer skills with the ability to learn inventory systems and tracking software quickly, • Comfortable working with data, order numbers, SKUs, and documentation, • High attention to detail and accuracy, • Ability to prioritize tasks and work independently, • Basic understanding of warehouse safety and inventory control best practices Preferred Skills • Experience with WMS, ERP systems, or inventory databases, • Familiarity with barcode scanning and electronic tracking, • Strong organizational and problem-solving skills, • Ability to work in a fast-paced, deadline-driven environment Physical Requirements • Ability to stand, walk, lift, and move materials throughout the shift, • Must be able to lift up to 50 lbs as needed

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

Job DescriptionJOB DESCRIPTION:The GCP Quality Assurance Auditor will report to the Director the GCP/PVG Quality Assurance. This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Company’s compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits. This position will provide day-to-day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials. The Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates. The ideal candidate will have extensive GCP experience. This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies. They are based in Northern New Jersey and require the candidate to be on-site. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance RESPONSIBILITIES:Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials. Plan and conduct audits of specific clinical processes based on risk. Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor. Develop audit reports and distribute them to appropriate stakeholders. Own and manage related clinical vendor non-conformances. Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.). Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors. Support the preparation, coordination, and participation of regulatory agency inspections. Participate in and support quality improvement projects. QUALIFICATIONS:5+ years of pharmaceutical experience 2+ years of RadioPharmaceutical and Quality Assurance experience BS degree in scientific, health care or related discipline Intensive GCP and safety background Experience with both internal and external process and systems audits Strong knowledge of development policies, procedures and standards (SOPs, QMS) Ability to work with global clinical teams in developing objectives for audits of clinical studies 10% Traveling required

Job DescriptionJob Title: REMOTE Territory Sales Manager – Specialty Chemicals & APIsCompensation: $100,000–$130,000 base + performance incentives Location: Remote (U.S.) Industry: Specialty Chemicals / APIs / Pharmaceutical Intermediates Overview A global manufacturer of specialty chemicals and pharmaceutical ingredients is expanding its North American commercial team. This is a high-impact sales role focused on growth within key verticals including iodine derivatives, intermediates for anti-cancer and contrast media, and active pharmaceutical ingredients (APIs). The role is modeled on a proven sales structure used for similar markets, emphasizing relationship management, business development, and strategic positioning across nutraceutical, pharma, and fine chemical sectors. Key Responsibilities * Drive sales growth across the North American territory for specialty and pharmaceutical-grade chemical ingredients. * Identify, target, and close new business opportunities across the following categories: * Iodine derivatives * Anti-cancer drug intermediates * X-ray and contrast media intermediates * APIs and stomach-related APIs * Develop and maintain relationships with key accounts, distributors, and manufacturers. * Collaborate closely with global production and regulatory teams to ensure compliance and delivery. * Analyze market trends and identify high-value prospects for long-term partnerships. * Represent the company at key trade shows and industry events (e.g., IBIE, CPhI, SupplySide West). * Prepare detailed reports and forecasts for executive management. Qualifications * Bachelor’s degree in Chemistry, Chemical Engineering, or related field (advanced degree a plus). * Minimum 5 years of experience in B2B sales of specialty chemicals, APIs, or pharmaceutical intermediates. * Proven track record of achieving revenue goals and building strategic partnerships. * Familiarity with regulated markets (FDA, REACH, GMP) preferred. * Exceptional communication, negotiation, and presentation skills. * Self-motivated, entrepreneurial mindset; able to operate with minimal supervision. Compensation & Benefits * Base salary between $100,000 and $130,000, depending on experience. * Performance-based commission and annual bonus structure. * Health coverage, paid time off, and travel reimbursement. * Long-term growth opportunity with a global chemical leader expanding in the U.S. market.

Job DescriptionReports to: GCOQ – Global Chief of Quality (Functional/Global Alignment) Department: Quality Assurance / Quality Control Supervises: Regulatory Associates, Technicians Organizational Relationships: QA/QC, Production, Warehouse, Engineering, R&D, Sales Project Managers, Account Executives, Operational Personnel, Customers, Regulatory Agencies, External Vendors/Suppliers, Global Quality Teams Responsibility Summary: The Manager – Regulatory is responsible for supporting site regulatory operations while ensuring alignment with global regulatory strategy and corporate quality standards. This role oversees regulatory compliance, submissions, raw material management, and cross-functional coordination to ensure full adherence to applicable global regulations. The position serves as the primary regulatory lead for operational execution at the site and ensures effective communication between site operations and global quality leadership. Responsibilities: • Oversee issuance of Raw Material regulatory statements including Origin, REACH, Allergen, Nitrosamine-Free, EU/China compliance, and other global declarations., • Direct vendor communication and ensure timely collection and verification of regulatory documentation., • Review and approve compliance documentation (CoCs, CoAs, CoMs, BSE, CMR, SDS, RM documentation, etc.) for domestic and international requirements., • Support regulatory submissions related to Organic (USDA/Ecocert), Gluten-Free, MoCRA, CARES Act reporting, and other regulatory programs., • Oversee regulatory compliance documentation generated through internal and third-party systems., • Conduct regulatory review of formulas and ingredients to ensure compliance across all intended markets; proactively identify regulatory risks and implement mitigation plans., • Support the development, review, and maintenance of Product Master Files (Dossiers), Drug Master Files (DMF), and global regulatory submissions., • Support preparation, coordination, and response activities for regulatory inspections, cGMP audits, and environmental audits., • Ensure ongoing compliance with FDA (21 CFR 210/211/820), EPA, OSHA, TGA, Health Canada, ISO, EU, China CSAR, Japan, and other applicable global regulations., • Support regulatory-related SOP development, Change Control, and QMS compliance., • Monitor evolving global regulatory requirements and implement necessary updates to maintain compliance., • Provide regulatory leadership guidance to cross-functional teams and support global quality initiatives., • Act as regulatory delegate for the site, as required. Qualifications: • Bachelor’s Degree in Life Sciences, Engineering, or related field., • Minimum 5 years of regulatory experience in pharmaceutical, cosmetic, medical device, food or related regulated industry, • Working knowledge of FDA regulations (21 CFR 210, 211, 820), • Strong leadership, cross-functional influence, and communication skills, • Analytical and regulatory risk assessment capability Compensation & Benefits: • The approximate pay range for this position is $75,000 to $90,000 per year. Final compensation may vary based on factors including but not limited to knowledge, skills and abilities. Powered by JazzHR f3g5lWItFW

Job Description The Fountain Group is currently seeking a QA Specialist for a prominent client of ours. This position is located in Ridgefield, NJ. Details for the position are as follows: Job Description: Pay: $44/hr Shift: 100% Onsite, 1st Shift Duration: 12-months – potential to extend or convert based on performance and budget. REQUIRED Qualifications: • Bachelor's degree in science disciplines., • Minimum two years of pharmaceutical industry experience., • Extensive Supplier Management experience,, • Strong understanding in FDA CFR Parts 11, 210, 211, and 820, ISO 13485, 9001 and/or other applicable regulations., • Strong knowledge of quality and compliance in a regulated GxP/QMS environment., • Handling ASL and QTAs, usage of Athena, QMS System, • Very good communicator, writing and organizational skills., • Ability to multi-task., • Adaptable to change., • Ability to work in a team as well and individually., • Ability to draw on past experiences to influence future outcomes., • Ability to research information for problem resolution to projects. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy #LI-MT2 #Zip

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 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 Why Join the HWP Group? Health & Wellness Partners, LLC (HWP), is a medical and scientific communications agency that collaborates with life science industry stakeholders to develop award-winning solutions that advance patient care and transforms scientific content into compelling live and virtual user experiences through digital platforms, congress engagement, and more. We bring clients, providers, and patients outstanding educational programming paired with innovative digital and interactive dissemination vehicles. We are committed to making a difference in health care and in the lives of our team members. We aim to provide every employee with a job they love in a culture focused on career growth, well-being, and community outreach. We have been recognized as both an MM+M Best Place to Work and an Inc. Best Workplace. For more information, visit thehwpgroup.com. What You Need to Know We’re looking to add an Account Manager, Speaker Bureau to our team. The Account Manager, Speaker Bureau supports the execution, compliance, and operational delivery of Speaker Bureau programs. Working under the supervision of the Account Director, Speaker Bureau, this role ensures that all aspects of speaker engagement, from tiering and contracting to training and program execution, align with client objectives, company standards, and regulatory compliance. What You’ll Do The Account Manager, Speaker Bureau is accountable to the VP/SVP Group Account Lead, Speaker Bureau, and Account Director, Speaker Bureau, and is responsible for the executional and operational integrity of assigned Speaker Bureau programs, serving as an operational bridge between internal teams and external partners. In addition, this role will: • Monitor overall account activity, timelines, and budget adherence in partnership with the Account Director, Speaker Bureau, identifying trends and recommending process improvements, • Serve as liaison between internal stakeholders and external partners, ensuring alignment across all program activities, • Maintain accurate speaker rosters, utilization data, and engagement tracking to support business planning and equitable speaker distribution, • Partner with Compliance, Legal, and Procurement to oversee speaker contract development, renewals, and adherence to Fair Market Value standards, • Support audit preparation and response, ensuring audit-ready documentation for all speaker activities, contracts, and payments, • Contribute to the development and maintenance of Standard Operating Procedures and training materials to promote consistency and compliance, • Manage operational data within internal systems, ensuring accuracy and data integrity., • Coordinate speaker onboarding, credentialing, background verification, and training activities., • Schedule and facilitate status meetings, • Prepare and distribute detailed Contact Reports and Status Reports, • Submit and track project initiation requests and client deliverables via WorkFront, • 3–5 years of experience in the pharmaceutical, biotech, or healthcare industry; experience in Speaker Bureau operations, HCP engagement, or contract management preferred, • Strong understanding of HCP engagement regulations, including the PhRMA Code, OIG requirements, Sunshine Act, and FDA promotional guidelines, • Proficiency in Microsoft® Office Suite (Access, PowerPoint, Excel, Outlook) and CRM/Speaker Bureau platforms such as Veeva, HubSpot, or equivalent systems, • Working knowledge of contract management systems, speaker payment processes, and reporting tools, • Demonstrated responsiveness, accountability, and commitment to service excellence, • Strong analytical skills with the ability to interpret data and translate insights into actionable recommendations, • Excellent written and verbal communication skills, with the ability to clearly and confidently engage diverse stakeholder groups, • Proven ability to build trusted partnerships with both internal and external teams, • Immediate eligibility for all benefits, including medical, dental, vision, group term life, short-term and long-term disability, • Benefits 100% company paid, • 401k plan employer matching contributions, • Eligibility for company sponsored incentive plans, • Generous PTO, including a week off in December for the holidays, • Paid volunteer time off, • Tuition reimbursement, • On-site gym and other employee wellness initiatives, • Employee Assistance Program, • Comp pay or comp time for onsite weekend work, • Availability of cell-phone stipends, based on business need, • Leadership development training program and other career development programs, • Remote and hybrid work schedule options, • Office locations in Upper Saddle River NJ (HQ), Red Bank NJ, and San Diego CA Please note, we will only respond to candidates we deem qualified

Job Description Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant with our direct client, a energy and utility company in Newark, NJ. This is a Hybrid role see details below. This role will be onsite and available to candidates local to the Newark, NJ area. We are interested in every qualified candidate who is eligible to work in the United States. Unfortunately, we are not able to sponsor visas or employ corp-to-corp Business Development Manager - Energy Efficiency Program Support Manager Location: Hybrid – Newark, NJ - 1 day per week Supporting Clients in Central and South New Jersey 12 Month Contract Pay Rate: $60-$65/hr w2 Mileage Reimbursement Job Summary Oversee the performance of vendor(s), both office and field, that have been contracted to deliver program services Ensure vendor and employee compliance with safety protocols and practices Lead and participate in cross-functional teams, including other RES members, Customer Care, Contracting, Procurement, Legal, Marketing, IT etc, as required to deliver program services Enhance program delivery/customer experience and resolve business/customer issues Develop and maintain the processes for implementing energy efficiency projects and programs in accordance with requirements for BPU approved programs Provide oversight for business controls, process improvement and compliance Ensure accurate invoice processing Identify and implement process improvements and automate where possible Monitor program Key Performance Indicators to ensure program delivery meets business plan expectations Prepare and present program and project status reports to senior management Assist with special projects as necessary This leader must foster an inclusive work environment and respect all aspects of diversity. Must demonstrate and value differences in others' strengths, perspectives, approaches, and personal choices During storm restoration efforts, may be required to perform functions outside of routine duties and on a schedule that may be different from normal operation Job Responsibilities Oversee the performance of vendor(s), both office and field, that have been contracted to deliver program services; manage employee performance; ensure safety protocols and practices are followed. Lead and participate in cross-functional teams, including other RES members, Customer Care, Contracting, Procurement, Legal, Marketing, IT etc, as required to deliver program services, enhance program delivery/customer experience and resolve business issues. Develop and maintain program processes. Provide oversight for business controls, process improvement and compliance. Ensure accurate invoice processing. Identify and implement process improvements and automate where possible. Monitor program Key Performance Indicators to ensure program delivery meets business plan expectations and regulatory requirements; Prepare and present program and project status reports to senior management. Required: B.S. Degree in Management, Engineering, Business, Finance or other relevant field or equivalent work experience plus 7 years of experience in the space of energy efficiency programs, construction, or related fields. In lieu of a degree, 11 years of experience in the space of energy efficiency programs, construction, or related field. Experience managing vendor performance, and leading cross-functional teams; Energy Efficiency or Electric Vehicle program experience Management/leadership experience working with cross-functional teams Valid US driver's license Desired: Certified Energy Manager (CEM) certification MBA or Advanced Degree Company DescriptionA WBENC (woman owned) certified company; Source One provides a full range of professionals to the Pharmaceutical & Healthcare, Defense, Technology, Financial Services, Retail & Manufacturing, and Energy & Transportation industries nationwide.A WBENC (woman owned) certified company; Source One provides a full range of professionals to the Pharmaceutical & Healthcare, Defense, Technology, Financial Services, Retail & Manufacturing, and Energy & Transportation industries nationwide.

Job Description Instrumentation Controls Technician Location: Lyndhurst, NJ Schedule: Monday – Friday | 2:00 PM – 10:30 PM (2nd Shift) Pay: $35 – $40 per hour Type: Contract-to-Hire Are you the kind of person who can look at a control panel, hear a weird machine noise, and immediately start diagnosing the problem in your head? If PLCs, instrumentation, and troubleshooting industrial equipment are your thing, this could be a great fit. We are seeking an Instrumentation Controls Technician to support a busy manufacturing facility in Lyndhurst, NJ. In this role, you will work with plant systems, instrumentation, and control equipment to ensure operations run safely and efficiently. You will also help maintain calibration programs, troubleshoot automation issues, and support plant operations when technical challenges arise. If you enjoy solving technical problems and working hands-on with equipment and control systems, this is a strong opportunity with a company that values technical expertise. What You'll Do * Troubleshoot and maintain PLC and control systems supporting plant equipment * Maintain and repair instrumentation, sensors, and electrical systems * Analyze and test computer control systems based on system design specifications * Support machine operating systems and control programs * Perform instrument calibration and calibration documentation * Manage calibration schedules and maintain compliance with ISO 9000 requirements * Diagnose issues with labeling equipment and automated systems * Perform scheduled maintenance on electrical and electronic devices * Provide rotational weekend on-call support for plant operations when required What We're Looking For * Strong troubleshooting and analytical skills * Solid electrical and controls background * Experience with PLCs (Allen-Bradley preferred) * Experience with pneumatic and hydraulic systems * Ability to read technical drawings, P&IDs, and ladder logic diagrams * Experience performing instrument calibration * Strong communication skills and ability to work independently or on a team * Experience in industrial manufacturing environments such as chemical, pharmaceutical, or food processing is preferred * Technical school training or related degree preferred * Experience with CMMS systems and smart instruments is a plus Additional Details * Schedule: Monday–Friday, 2:00 PM – 10:30 PM * Pay: $35–$40/hour * On-Call: Weekend rotation for plant support * Position Type: Contract-to-Hire * Location: Lyndhurst, NJ About Zing Recruiting Zing Recruiting is an Equal Opportunity Employer. We do not discriminate on the basis of race, color, religion, sex (including pregnancy, sexual orientation, and gender identity), national origin, age, disability, genetic information, or any other protected status under federal, state, or local law. We are committed to fostering a diverse and inclusive workplace. #ZINGZIP #ZINGNJ Company DescriptionZing Recruiting is dedicated to delivering candidates and client’s alike a great experience for each unique position. We specialize in finding dedicated professionals with the education, talent, and fresh perspectives – professionals at the top of their game. Professionals who have what it takes to be competitive and innovative in today’s market. We work to match candidates needs and requirements to our clients’ requirements and expectations. We work to find the right “fit” for both candidate and client.Zing Recruiting is dedicated to delivering candidates and client’s alike a great experience for each unique position. We specialize in finding dedicated professionals with the education, talent, and fresh perspectives – professionals at the top of their game. Professionals who have what it takes to be competitive and innovative in today’s market. We work to match candidates needs and requirements to our clients’ requirements and expectations. We work to find the right “fit” for both candidate and client.

Job DescriptionQuality Assurance ManagerAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Manager, Quality Assurance manages the PPU support unit services of the QA department and overall expectations pertaining to setting accurate schedules and resources. The Manager, Quality Assurance is responsible for performing Quality Assurance activities with minimal if any supervision of daily tasks in support of corporate Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, QC data, SOPs, material releases and final product releases as well as assists Quality management with department needs. The ideal candidate in this role, the Manager, Quality Assurance exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Implements ongoing quality improvement processes working with interdepartmental teams. Develop and manage quality assurance metrics for performance improvement of all teams. Anticipates program release problems and takes corrective action, escalating as needed, to resolve and achieve commitments. Works with project managers to develop project schedules and resource allocation models for QA related projects and other activities such as software deployment, customer integration, and professional services validation. The QA Manager will delegate responsibilities to direct reports (QA Associate I, II, and III) to achieve the requisite business needs, while providing ongoing support to Manufacturing processes. • Ensure the safe release of cellular products in accordance with HCATs and/or client procedures and requirements., • Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs, • Provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues., • Establish and maintain policy for documentation of all products and perform internal documentation audits., • Author and review relevant SOPs, validation and other documents., • Ensure timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports., • Ensure the completion of all client requirements related to cellular product and/or material releases, including documentation review., • Control Master Batch Records, distribution and label verification., • Perform line clearance activities as required., • Assign and maintain product lot numbers as applicable., • Ensure materials management nonconformance disposition and release activity as applicable., • Ensure accurate deviation reporting as applicable and tracking/trending follow up actions to closures, • Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions., • Provide Quality Assurance related support to various departments., • Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies., • Monitor and maintain the corrective action process which included driving and coordination of the investigation, root cause analysis, action plan, and effectiveness checks., • Provide support to manufacturing for investigations of deviations, validations, and development of specifications, • Provides metrics for quality management reporting and helps to identify areas for further monitoring for improvements., • Effectively host client audits and provide on time response to audit findings as well as facilitate completion of corrective actions noted., • Perform employee training on QSR and ISO requirements and company quality systems, • Perform document control activities as assigned., • Mentor/train/develop and manage Quality Assurance team., • Lead the implementation of Quality Agreements with Clients and maintain compliance to Quality Agreements, • Travel may be requiredREQUIREMENTS, • BS Degree in biological sciences or equivalent., • Minimum 5-10 years related experience in the pharmaceutical or biologics industry., • Understanding of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs)., • Working knowledge of routine laboratory operations, equipment and systems, production processes, validation, etc., • Sound knowledge of aseptic processing and supporting technologies., • Analytical and technical troubleshooting skills are a plus., • Proficient with Microsoft Office Suite., • Excellent organizational skills and attention to detail., • Good verbal and written communication skills., • Strong team-oriented interpersonal skills are essential., • Strong business acumen, • 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, • Meeting management/facilitation skills/teamwork, • Ability to multi-task is essential, • Flexible and able to adapt to company growth and evolving responsibilitiesPlease 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 DescriptionQC Microbiology Compliance InvestigatorAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. 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, 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., • Manage 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 or equivalent experience., • 3-5 years of experience in quality control or quality assurance within the bio-pharma, biologics, or pharmaceutical industry or equivalent experience., • Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA, • Must have technical experience writing and assessing deviations, investigations, and Out of Specifications, • Must be able to analyze data/information and to assess and resolve complex problems, • Strong knowledge and understanding of U.S. and international cGMPs, ICH, and other regulations applicable to clinical and commercial manufacturing, • Knowledge of operational processes and controls in non-sterile and sterile operations, • 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., • Training; GMP Training, Quality Systems Training (Deviation/CAPA), Safety Training, 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. 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 DescriptionJob Summary: Instrument and Controls Engineer:The Instrument and Controls Technician is involved with the successful daily operation of the oil refining facility, and the modification and alteration of the plants automated control and power systems to accommodate business needs and ensure high plant availability. This requires close collaboration with other employees and management staff to ensure safe work and to set or re-set job priorities. Documentation, as required to document changes in plant physical or logic changes, and documentation to meet our goals of safety first, quality work and compliance with our customers’ requirements and concerns. Qualifications: Instrument and Controls Engineer: • High School Diploma or GED with at least 10 years I&E (I&C) experience in a chemical, food, pharmaceutical manufacturing environment. Familiarity with PLC based controls systems such as GE or Allen Bradley in a manufacturing environment., • Ability to analyze and interpret technical problems related to instrumentation or PLC logic., • Ability to read and understand company policies and procedures, technical datasheets or literature, P&IDs, electrical drawings (One-line drawings, loop drawings, control circuits, etc), • Ability to effectively present information either verbally or via written document (e-mail, MS Word/Excel, CMMS, etc) and respond to questions from groups of managers, co-workers, customers, and the general work force., • Ability to work with and apply mathematical concepts to practical situations., • Preferred: New Jersey Licensed Electrician (or working towards license), • Preferred: ISA Certification (Certified Control System Technician, Certified Industrial Electrician, Certified Instrument Technician)Duties & Responsibilities: Instrument and Controls Engineer:, • Monitor, repair, maintain and troubleshoot all field instrumentation, electrical equipment and controls systems including plant safety systems and plant power systems., • Install, loop check, maintain and troubleshooting process control systems comprised of transmitters, controllers, and valves operating in a PLC system., • Calibrate, monitor, repair, maintain, label and document all field instruments such as transmitters, controllers, valves, PLCs, plant safety systems, plant power systems, utility systems (HVAC), pH and conductivity meters, • Install, maintain, and troubleshoot electrical distribution and protection circuits up to 480VAC., • Fabricate and install rigid and flexible conduit, and run power and control wiring based on electrical code requirements, • Properly select, install and wire 120V-480V motors, single phase to three phase based on needs, • Strong working knowledge of National Electrical Code (NFPA 70), • Evaluate current instrumentation technology for process equipment and make recommendations for improvements., • Ensure all work orders are completed, documented and closed out in the site CMMS system, as per procedure., • Provide on-call support during assigned weeks to ensure 24/7 coverage, • Provide practical solutions to operations/ controls problems., • Scope, estimate and execute small capital / maintenance projects along with maintenance manager/ project director/ operations, etc., • Train other employees considering their needs and company needs., • Oversee the work by contractors as required on site to ensure safe and quality performance.

Job Description POSITION TITLE: Compliance Coordinator POSITION REPORTS TO: Facility Manager Position Summary August Tenth Capital Investments — operating under our new adult-use cannabis brand My Dad’s Stash — is preparing to launch a state-licensed cultivation and processing facility in the coming months. We are building a high-performing team excited to join a ground-floor startup environment and help shape one of New Jersey’s newest and most compliant cannabis operations. We are seeking a Compliance Coordinator who will serve as the primary leader responsible for ensuring operational compliance across cultivation and post-harvest functions. This role oversees regulatory requirements issued by the New Jersey Cannabis Regulatory Commission (CRC), manages SOP development and revisions, supports METRC accuracy, and acts as the facility’s primary point of contact during regulatory inspections. The Compliance Manager will work closely with cultivation, harvest, packaging, and operations teams to ensure all activities are performed in alignment with company policies, safety standards, and state regulations. This position requires a detail-driven, organized, and proactive leader capable of maintaining transparency, accountability, and operational excellence within a fast-growing startup environment. Key Responsibilities • Lead and oversee all compliance efforts across cultivation and post-harvest operations to ensure adherence to New Jersey CRC regulations and all applicable state requirements., • Serve as the facility’s primary point of contact for regulatory inspections, audits, site visits, and corrective action implementation., • Develop, review, and maintain Standard Operating Procedures (SOPs) for cultivation, sanitation, inventory tracking, waste disposal, and operational compliance while managing document control and version updates., • Conduct internal compliance audits of METRC data, plant and package inventories, plant movement records, waste logs, harvest batch records, and facility documentation., • Identify discrepancies within METRC or seed-to-sale tracking systems and collaborate with department leaders to resolve issues promptly and maintain accurate records., • Monitor regulatory updates and policy changes issued by the New Jersey Cannabis Regulatory Commission and communicate relevant updates to leadership and staff., • Develop and deliver compliance training programs for new hires and ongoing employee education to ensure consistent understanding of regulatory requirements and company procedures., • Work collaboratively with cultivation, harvest, post-harvest, and packaging teams to ensure compliance is integrated into daily operations including plant tracking, labeling, waste disposal, and documentation procedures., • Review product labeling and packaging information to ensure all required warnings, batch information, testing verification, and CRC-required disclosures are accurate and compliant., • Prepare and maintain regulatory reports, inspection records, training logs, audit documentation, and other compliance-related records., • Track key compliance indicators and operational risk factors while working with department leaders to implement corrective and preventive action plans when needed., • Ensure compliance issues are documented, investigated, and resolved appropriately and in a timely manner., • Maintain professional working relationships with regulators, inspectors, and third-party partners while ensuring the facility remains inspection-ready., • Participate in cross-department meetings to ensure new processes, facility changes, and equipment installations meet regulatory requirements., • The ideal candidate will have three or more years of compliance experience, preferably within the cannabis industry or other regulated industries such as pharmaceutical manufacturing, agriculture, food production, or regulated manufacturing environments., • Candidates should have a strong understanding of New Jersey cannabis laws and regulations (N.J.A.C. 17:30) and experience working within regulatory compliance frameworks., • Experience with METRC or other seed-to-sale tracking systems and conducting inventory reconciliations or internal compliance audits is strongly preferred., • The candidate must demonstrate exceptional organizational skills, strong attention to detail, and the ability to interpret regulations and translate them into practical operational procedures., • Strong written and verbal communication skills are required, along with the ability to train and support employees on compliance practices and SOP implementation., • Candidates should be comfortable managing multiple projects and deadlines within a fast-paced startup environment and be proficient in Microsoft Office applications including Word, Excel, and PowerPoint., • Applicants must be 21 years of age or older and able to meet all New Jersey Cannabis Regulatory Commission requirements, including background checks, fingerprinting, and agent registration., • A Bachelor’s degree is preferred, though equivalent experience in regulatory compliance or cannabis operations may be considered.Company DescriptionWe are a licensed cannabis cultivation facility in North Plainfield, NJ focused on producing high-quality cannabis through modern cultivation techniques. As a growing company in New Jersey’s emerging cannabis industry, we are building a team of hardworking individuals who value attention to detail, teamwork, and professionalism. Our goal is to create a positive workplace where employees can grow alongside the company.We are a licensed cannabis cultivation facility in North Plainfield, NJ focused on producing high-quality cannabis through modern cultivation techniques. As a growing company in New Jersey’s emerging cannabis industry, we are building a team of hardworking individuals who value attention to detail, teamwork, and professionalism. Our goal is to create a positive workplace where employees can grow alongside the company.

Job DescriptionJob Title: REMOTE Territory Sales Manager – Specialty Chemicals & APIsCompensation: $100,000–$130,000 base + performance incentives Location: Remote (U.S.) Industry: Specialty Chemicals / APIs / Pharmaceutical Intermediates Overview A global manufacturer of specialty chemicals and pharmaceutical ingredients is expanding its North American commercial team. This is a high-impact sales role focused on growth within key verticals including iodine derivatives, intermediates for anti-cancer and contrast media, and active pharmaceutical ingredients (APIs). The role is modeled on a proven sales structure used for similar markets, emphasizing relationship management, business development, and strategic positioning across nutraceutical, pharma, and fine chemical sectors. Key Responsibilities * Drive sales growth across the North American territory for specialty ingredients, vitamins, chemicals and minerals for sports nutrition * Identify, target, and close new business opportunities across the following categories: * Supplement Manufacturers * Contract Manufacturers * * Develop and maintain relationships with key accounts, distributors, and manufacturers. * Collaborate closely with global production and regulatory teams to ensure compliance and delivery. * Analyze market trends and identify high-value prospects for long-term partnerships. * Represent the company at key trade shows and industry events (e.g., IFT, SupplySide West). * Prepare detailed reports and forecasts for executive management. Qualifications * Bachelor’s degree in Chemistry, Chemical Engineering, or related field (advanced degree a plus). * Minimum 5 years of experience in B2B sales of ingredients, vitamins, chemicals and minerals for sports nutrition * Proven track record of achieving revenue goals and building strategic partnerships. * Familiarity with regulated markets (FDA, REACH, GMP) preferred. * Exceptional communication, negotiation, and presentation skills. * Self-motivated, entrepreneurial mindset; able to operate with minimal supervision. Compensation & Benefits * Base salary between $100,000 and $130,000, depending on experience. * Performance-based commission and annual bonus structure. * Health coverage, paid time off, and travel reimbursement. * Long-term growth opportunity with a global chemical leader expanding in the U.S. market.

Job DescriptionSalary: Pharmaceutical Sales Representative Opportunity with Galt Phranchisee, VK Health Innovations, LLC., for the Hackensack, NJ territory. Candidates acknowledge that this is an opportunity to be employed or contracted with Galt Phranchisee, VK Health Innovations, LLC., who is licensed to promote and market Galt Pharmaceuticals products in the Hackensack, NJ territory. Candidates also consent to forwarding their resume and contact information to the phranchisee to be considered for this position. The role of the Pharmaceutical Sales Representative is to develop and manage accounts within the territory through provider offices and retail distribution, while effectively managing expenses. The Pharmaceutical Sales Representative position requires a unique set of business skills (e.g. financial and data analysis) to profitably manage franchise activities as a surrogate for the Phranchise Owner. This position requires sales experience with a Business Owner mentality. Incumbents and candidates who possess an entrepreneurial spirit, and the ability to identify both opportunities and solutions that result in a value-based relationship with accounts as well as profitably make a return on investment for the Phranchise Owner are well suited for this dynamic and challenging position. Responsibilities: Business Development Develops the territory franchise as a business profit center. Develops the business plan to achieve sales goals which includes Account Identification, Marketing Initiatives, Expense Allocations, and Time Management. Develops a minimum of 20 accounts which result in Galt 10 parameters. Develops strategic partnerships with healthcare practices and pharmacies. Participates in Territory Business Reviews with Phranchise Owners. Collaborates with corporate business functions (marketing, supply chain, operations, sales) to share creativity and results which leads to best practices across the organization. Territory Management Represents Galt Pharmaceuticals through a demonstrated understanding of Galts Vision and Principles. Understands the social/political culture of communities within the franchised territory. Performs data analysis to evaluate targeting, trends and prospecting. Uses tools such as CRM, sales and prescription data to measure performance and activities. Approaches territory management through people centricity rather than by targeting competitive products. Represents Galt Pharmaceuticals within the territory as A Better Way to deliver pharmaceutical care, one patient at a time. Prepares for and adapts to changes in the business, territory and market that results in continued growth of accounts. Makes sound financial decisions saving on time and expenses. When required, work with accounting and compliance departments to assist with collecting any payments, and required documentation for pharmacy accounts. Implements efficient routing and execution of market strategy in healthcare offices, pharmacies, physicians, and anchor pharmacies based upon the Galt Sales Process. Account Management Implements Galt Account Management & Sales Processes. Works with accounts to solve problems, bringing value to the business and focused care to customers, and application(s) of product knowledge and benefits. Differentiates the business through white glove, concierge service that brings true value to customers. Actively listens to internal and external stakeholders to identify barriers, gaps and opportunities. Facilitates solutions through excellent problem-solving skills, and knowledge of both the business and customer. Professional Skills: Outstanding interpersonal, improvisational and solutioning skills. Strong metacommunication skills, active listening and oral presentation. Command of complex medical and pharmaceutical terminology. Proficiency in the use of iPads, computers, and mobile devices. Intermediate computer skills required (iOS, Windows, Word, and Excel). Self-motivated and the ability to work independently without supervision. Ability to manage multiple tasks and priorities simultaneously. Demonstrates integrity, high ethical and professional standards in all interactions. 1-2 years of B2B, DME, or healthcare sales experience preferred. Must be pursuing a Bachelors Degree in Life Sciences or Business-related area preferred. Employment Requirements: Must pass Sales and Clinical/Compliance Training. Valid Drivers License and safe driving record.

Job Description We’re seeking a Warehouse Group Leader to oversee inventory handling, personnel coordination, and day-to-day warehouse operations within a food-grade manufacturing environment. This role requires strong leadership, attention to detail, and the ability to manage product flow, documentation accuracy, and compliance with all food safety, GMP, and company standards. You’ll lead a shift of warehouse personnel, ensure accurate receiving and inventory control, coordinate outbound shipments, and support safe, efficient warehouse operations. Compensation • $22 hr, • Shift Leadership & Team Coordination – Assign tasks, supervise warehouse personnel, provide training, and ensure smooth shift operations. Step into full departmental responsibility when the Warehouse Manager is absent., • Receiving & Inventory Management – Receive finished goods, verify materials against invoices, maintain accurate inventory counts for raw, packaging, and finished goods, and ensure all items are properly tagged, labeled, and stored., • Shipping & Material Handling – Oversee loading and unloading of freight, ensure FIFO is followed for incoming and outgoing products, coordinate transportation schedules, and validate outbound accuracy., • Compliance, Documentation & SAP Use – Maintain complete and accurate paperwork for all inbound/outbound transactions; operate SAP warehouse applications and handheld scanners for receiving, posting, and tracking materials., • Quality, GMP & Food Safety Standards – Ensure all warehouse activities follow GMP, food-safety, and safety guidelines. Maintain a clean work area, ensure tools/equipment function properly, and immediately report discrepancies or damages., • Forklift Operation & Safety – Complete forklift and trailer inspections, maintain a zero-damage standard, and uphold a clean safety record in accordance with company policies., • Supplier & Customer Coordination – Communicate with suppliers regarding delivery schedules, prepare product samples as needed, and assist in reviewing open sales orders to ensure adequate inventory allocation Qualifications • Experience – Minimum 2 years of warehouse experience in a manufacturing environment, ideally within food, pharmaceutical, or nutraceutical industries., • Leadership & Teamwork – Demonstrated ability to lead a shift, train staff, delegate tasks, and maintain smooth warehouse operations., • Technical Skills – Experience with handheld scanners; ability to use SAP or similar warehouse management systems; strong understanding of inventory practices and FIFO., • Forklift Certification – Valid forklift license/certification with a strong safety record., • Documentation & Compliance – Ability to complete and manage paperwork accurately while following SOPs, GMPs, and food-safety guidelines., • Communication – Ability to read, write, and speak English effectively; strong coordination and reporting skills., • $22 hr, • Medical, dental, vision

Job DescriptionWe are looking for an experienced Account Director to work with our clients to deliver the P10 experience. As a part of the team, you will play a pivotal role in building and maintaining strong client relationships, driving client success and account growth, and ensuring the successful execution of marketing campaigns and tactical pull through. You will be the conduit between our clients and the delivery team, collaborating closely with project management and your core internal team to ensure project delivery and client satisfaction. You have a deep understanding of pharmaceutical marketing, exceptional organizational skills, and a relentless commitment to client satisfaction. You will report to the Senior Director, Client Services. This role is open to fully remote candidates in PA, NJ, or NY due to client travel requirements.Responsibilities: • Client Relationship Management:, • Build and cultivate strong, long-lasting client relationships., • Serve as the primary point of contact for clients, understanding their needs, objectives, and ever-changing challenges., • Proactively work to identify areas of opportunity to add value to your accounts. Strategic Account Management:, • Understand the client’s business, disease area(s), and brand/product strategy., • Work collaboratively with clients and the P10 internal team to develop and execute unique and powerful strategic marketing plans for your brands., • Collaborate with cross-functional teams to ensure the successful execution of marketing campaigns and projects. Financial Oversight:, • Work with the Director, Operations to manage account budgets, forecasts, and financial performance., • Identify opportunities for revenue growth and cost optimization while maintaining profitability.Requirements:, • Bachelor's degree in Communications, Marketing, Business or other related field., • 8+ years of experience in pharmaceutical advertising managing the development of HCP and/or DTC promotional campaigns. Experience with new product launches and label updates is a plus., • Proven track record of building and managing client relationships, continuously delivering successful marketing solutions and achieving revenue growth., • Strong understanding of medical, legal and regulatory compliance and MLR submission and approval process in the United States and/or Canada., • Excellent communication, negotiation, and presentation abilities.

Job Description About Us: Second Melody is a branding studio with a diverse client portfolio, including a strong presence in health and biotech. Our focus is strategic brand alignment across corporate messaging, internal culture, audience outreach, advocacy and education. Our mission is to help our clients solve problems by building stronger and more inclusive brands that accurately represent their visions, passions, and business goals. Role Overview: At Second Melody, we believe in building meaningful, lasting relationships with our clients and within our team. As a Senior Account Manager, you’ll support those connections by serving as a primary contact between clients and internal teams, ensuring clear communication, alignment, and client satisfaction. Working closely with the Director of Accounts and cross-functional team members, you’ll manage day-to-day communications, ensuring the strategic direction of the brand is aligned to projects and client needs are met. You will build, maintain, and grow relationships with clients, leading to organic growth. This is a client-facing role suited for someone organized, curious, and eager to lead in a purpose-driven creative environment. Job Responsibilities Business Management & Development • Manage the development of scopes of work and annual budgets for assigned account(s) in partnership with internal team, • Oversee estimates, billing, job closeouts, and financial tracking to support account profitability; ensure team compliance with Teamwork for accurate billing, • Identify organic growth opportunities by understanding client goals and making suggestions to supervisor and ultimately client, • Participate in internal brainstorms and planning sessions, contributing ideas and capturing action items aligned to client strategic objectives, • Build knowledge of brands, market, and business objectives; monitor market and competitive trends, • Participate in new business pitches as opportunities arise Client Relationship • Serve as day-to-day client contact for assigned clients, managing daily communication, setting expectations, and building trusted relationships, • Lead client meetings, tactical project discussions with strategic references, and status calls, ensuring clear documentation of decisions and action items; attend workshops and conferences, • Develop Project Briefs that align with client objectives, timelines, and budgets; provide clear direction and strategy to internal team members, • Review and approve creative deliverables before client presentation, ensuring strategic alignment, accuracy, and consistency with the Brief, • Lead tactical project execution, addressing client feedback and challenges with timely solutions; capture feedback, asking strategic questions to guide revisions and maintain project focus, • Operate within internal workflows and client processes throughout project lifecycle, • Set and manage client expectations regarding deliverables, timelines, and budgets Leadership & Collaboration • Foster and inspire a deeply collaborative atmosphere and culture, • Present work to clients for approval with cross-functional team members; solicit feedback on tactical execution, • Collaborate with cross-functional team members to deliver on Project Briefs, client expectations, and in accordance with brand guidelines, • Deliver work on time and in accordance with budgeted hours, • Work within agency systems and processes People Management What You Bring • 3+ years of pharmaceutical/biotech industry (in-house) or pharmaceutical/biotech agency experience managing branding-related projects across various mediums including but not limited to digital, print, environmental and events, • Ability to juggle multiple projects, meet deadlines, and stay solutions-focused, • Excellent written and verbal communication skills, • Experience presenting to clients, • Open, collaborative mindset—comfortable with feedback and iteration, • Detail oriented, organized, and proactive nature that anticipates client and internal team needs, challenges, solutions, • Proficient with Google Docs (including slide development) and agency workflow/project management systems, • Willingness to travel for client meetings or workshops as needed What We Value • A balance of task focus and people skills—able to collaborate with clients and colleagues alike, • Organized, resourceful, and proactive in managing multiple projects, • Exercises good judgment and knows when to ask questions or seek guidance, • Trustworthy and professional with sensitive information, • Driven, energetic, and committed to delivering high-quality work on time, • A genuine alignment with Second Melody’s mission and growth Hybrid Structure: While Second Melody’s offices are located in New Jersey, candidates are not required to reside in the state. However, they should be willing to travel to New Jersey for company events as needed. Benefits Time Off • Vacation - 12 days, • Personal - 12 days, • Sick - 5 days, • Medical insurance, Second Melody covers 75% of the employee's premium (available after 2 months of full-time employment), dependents can enroll at full premium, • Opportunity for promotion and internal career advancement available as necessary skills are developed and the company grows Salary Range: $85,000-$90,000

Job DescriptionAssociate Director, Manufacturing OperationsAllendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey. The Associate Director, Manufacturing Operations is responsible for efficient utilization of Operations resources to meet customer demand. This role will be responsible for maintaining and overseeing the site Operations scheduling and training capacities for a time period looking ahead to the next 3-6 months. The Associate Director, Manufacturing Operations will understand upcoming needs and constraints and help drive strategy accordingly. This includes the management of all Operations scheduling, training and compliance resources. The Associate Director, Manufacturing Operations is also responsible for assessing the needs of the company to contribute to the big picture by ensuring daily operations run smoothly and as efficiently as possible. 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. • Meeting client process demands through planning, scheduling, manufacture and delivery of clinical cell therapy products according to established procedures, regulations and contracts, • Looking out 3-6 months to ensure capacity and availability of resources (room/equipment/staff) to perform clinical manufacture for processing needs, • Manages all training and compliance activities in the Operations organization, • Responsible for creating, enforcing and measuring Operator training schedules in order to ensure that all production schedules can be carried out, • Creates and maintains a process to ensure that personnel schedules are being accurately and fairly assigned to all Associates, • Supporting and driving special long-term projects and identified and assigned by the PPU Head, • Responsible for creating maintaining and communicating all Operations based KPI’s, • Ensuring department staff compliance with corporate and site-specific HR policies, safety, and business policies and practices, • Approving job specific curriculum for the training and professional development of department staff, • Responsible for streamlining the batch record review process, • Responsible to understand the profit and loss for the PPU’s as well as all related documentation, and how these items impact Operations, • Driving continuous improvement, • Liaison with support groups for short- and medium-term needs – Supply Chain, Training, Quality Systems, Quality Assurance, Quality Control, and others, • Set team expectations and goals and assists in delivering the business direction for the PPU, • Aligning departmental goals, processes and resource allocation with the organizational strategy, • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws., • Direct reports: Associate Manager Training, Associate Manager, Compliance, Scheduling Associate, Quality Engineer Associates. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. REQUIREMENTS, • Bachelor's degree (i.e. Biology, Biotechnology, Bioengineering, Chemical Engineering)., • 5-10 years of cGMP environment, aseptic processing, mammalian cell culture, monoclonal antibody, cell processing, cryopreservation or similar experience., • 5-10 years of leadership experience or equivalent combination of experience., • Deep Understanding of cGMP and cGLP, • Working knowledge of financial operations and budget development, • Relevant IT skills (able to work with Microsoft Office and corporate scheduling system), • Competencies/Candidate Profile, • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment, • Flexible and able to adapt to company growth and evolving responsibilities, • Accountability, integrity, and strong dedication to regulatory compliance, • Strong business and personnel management acumen, • Strong emotional intelligence, • Ability to think strategically and tactically (detail-oriented), • Strong analytical and problem-solving skills, • Strong written and verbal communication skills, • Drive to create and maintain order in a fluid, technically complex environment, • Continuous improvement mindset, • Ability to multi-task is essential, • Must have the ability to work in a team-oriented environment and with clients, • Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.Environment requires gowning, hair net, safety glasses, gloves, and foot coverings.Must be capable of moving, sitting, stretching, stooping, using hands and fingers, reaching with hands and arms, talking and exchanging information, and vision sufficient to read materials.Duties, responsibilities, and activities may change at any time with or without notice

Job Description NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We're exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. In Japan. Summary: The Director, Patient Services, Marketing is responsible for designing and building patient support assets/activities and managing patient services support agency relationships and budgets. This role will use insight-driven patient services data to continuously optimize programs and inform brand strategy in order to build scalable, compliant solutions that address the unique needs of rare disease patients and caregivers. This role will align with the US Head of Patient Services in the development of the patient services strategy while working collaboratively with NSP internal cross-functional partners such as Patient Services, Market Access, Commercial Operations and Medical Affairs in tactical execution. Duties & Responsibilities: • Work with Head of Patient services to develop strategy and aligned tactics that support patients and families in navigating diagnosis and treatment burdens., • Develop patient assistance tools that maximize patient access to therapies; design and build patient support programs with internal and external stakeholders., • Develop and implement promotional communication resources in alignment with brand positioning and patient services strategy., • Drive innovation and program enhancements that will optimize customer service and patient access to rare-disease therapies by identifying emerging opportunities., • Establish analytic rigor within patient services and support data-driven decision-making for the commercial business., • Travel as necessary with Patient Services Field Teams to visit accounts and assist in presentations about company’s reimbursement strategy and services; attend commercial and other relevant business-related meetings., • Build and develop productive working relationships with external service providers and internal cross-functional stakeholders., • Ensure effective and compliant implementation of financial assistance programs., • Engage with Patient Engagement Leads and Directors of Patient Access in gaining insights and providing clear direction in use of assets and customer support programs., • Facilitate exceptional cross functional collaboration with customer facing teams, marketing, specialty pharmacy and hub personnel., • Design, incorporate and manage patient services content into brand websites and appropriate sales promotional resources., • Collaborate in the development and rollout of field-based patient services programs via promotional material related to patient support services, coverage, reimbursement and market access topics., • Conduct, analyze and communicate patient services competitive insights & research., • Manage agency performance and NS Pharma promotional budget effectively., • Knowledge of pharmaceutical regulatory requirements impacting marketing materials., • Strategic planning and execution skills including project/budget management and working effectively with external service partners., • Strong background in leading and managing people., • A true team player with the ability to work collaboratively with key internal stakeholders, • Excellent interpersonal and communication skills for cross-functional collaboration and influence., • Strong executive presence, commanding respect through sound business judgment and clear decision-making, • Strong project management skills, ability to multi-task and prioritize with quality., • Self-motivated, with excellent organizational skills, with ability to work collaboratively as a member of the Marketing team and individually., • Likes to work through others to gain success, secure accomplishments and meet objectives & goals., • Demonstrated ability to work in a diverse collaborative environment., • Ability to build organizational capabilities, • Bachelors Degree Required / Masters Degree Preferred., • 10 or more years working in the pharma/biotech required, 5 years working in market access / patient support services preferred., • Understanding of the cell and gene therapy marketplace and the specific access support needs for patients with rare diseases preferred., • In depth knowledge of pharmaceutical manufacturer compliance, patient confidentiality, product reimbursement and product access requirements., • Experience in product launch and portfolio management., • Knowledge of regulations and laws governing the protection of PHI (patient health information), and CMS policies pertaining to access services., • Proven track record developing and delivering patient access and reimbursement solutions in a high impact and cost-effective way., • Deep expertise in pharmaceutical brand implementation, communication planning, and patient activation., • Background working with patient and community advocacy groups., • Ability to work with hub operations or specialty drug patient services/call center inclusive of field functions., • Proactive, results oriented, self-starter with an ability to lead cross-functional teams., • Expertise in complex reimbursement environments., • Ability to analyze and interpret health care regulations, legislation, rulemaking, policy & advisory opinions. NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job. The annualized target salary range for this role is $195,000,000 to $215,000; actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit. Other benefits include: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs, • Discretionary Bonus Programs and Long-term Incentive Plan, • Retirement Savings 401k with company match, • Generous Paid Time Off, Sick Time & Paid Holidays including a paid Year-End Shutdown., • Career Development, Progression and Training, • Flexible Work Arrangement Programs Applications will be accepted until May 31, 2026, or until a candidate is hired. Applicants not hired will remain in our Talent community for future opportunity consideration. Thank you for your interest in NS Pharma. NS Pharma is an EEO employer.