Associate Manager, Quality Control

Amneal Pharmaceuticals LLC; Piscataway Township (NJ); On-site; USD 80,000 - 110,000; Full time

Job summary

Amneal is seeking a Laboratory Supervisor to organize testing schedules based on priorities and provide hands-on training to new hires. The role supervises daily testing activities to ensure adherence to cGMP, SOPs, and laboratory procedures, and participates in cross-functional teams to drive timely delivery of results.

The ideal candidate holds a BA/BS in Chemistry or related field (MS preferred) with 7+ years in pharmaceutical labs and at least 2 years in supervision, with strong analytical

Qualifications

• Bachelor's Degree in Chemistry or related technical field is required.
• Master's degree in Chemistry or related technical field is preferred.
• 7+ years pharmaceutical laboratory experience with 2+ years supervisory experience (Bachelor's); 5+ years with 2+ years supervision (Master's).
• Must understand analytical chemistry techniques (USP/EP/BP/JP) and cGMP requirements.

Responsibilities

• Schedule testing/reviews for materials and processes, ensuring advanced writing of assignments.
• Oversee lab activities to ensure data integrity and compliance with SOPs and cGMP.
• Initiate investigations (OOS/OOAL) and ensure CAPA is implemented.
• Review COA, stability reports, calibrations, and method validations as needed.
• Lead change controls for controlled documents and monitor method changes.

Skills

Analytical chemistry

Leadership

Training

Education

Bachelor's Degree in Chemistry or related field

Master's degree in Chemistry or related field (Preferred)

Job description

Description

This role prepares testing schedules based on priorities, provides hands-on training to new hires, supervises daily testing activities to assure adherence to procedures, cGMP, and SOPs applicable to laboratories, conducts laboratory investigations when needed, participates in cross-functional teams to understand priorities, commits and delivers as committed.

Job Description

This role prepares testing schedules based on priorities, provides hands-on training to new hires, supervises daily testing activities to assure adherence to procedures, cGMP, and SOPs applicable to laboratories, conducts laboratory investigations when needed, participates in cross-functional teams to understand priorities, commits and delivers as committed.

Essential Functions:

• Schedules testing/review of raw materials, in-process, finished product, and stability samples, complaint samples, samples from process and cleaning validation activities; assignments shall be in writing and a day in advance.
• Drives effective and efficient shop floor supervision enforcing compliance to data integrity, SOPs, specifications, methods, USP, and cGMP through real time verifications of records, LNB, log book, chromatograms, sequences, etc. Helps analysts by trouble shooting methods, instrumentation and execution of the tests.
• Initiates OOS/OOAL investigation, participates in investigation activities, and closes in the books when approved, in a timely manner. Prepares reports of investigation, method transfers, method verification/validation where required. Ensures implementation of CAPA, as identified during the investigations.
• Ensures timely testing and releases of raw materials, in-process, finished products, stability samples from the lab. Reviews and approves, COA, stability summary reports, investigations, APR trend data, calibrations, qualifications, and other analytical records as needed.
• Initiates change controls for revisions to any controlled document (SOPs, methods, stability protocol,and specification) applicable to quality laboratory.
• Reviews changes in compendial methods for applicable products and notifies management of such changes in order to determine appropriate course of action.
• Has all laboratory personnel complete weekly worksheet, reviews worksheets with respect to schedules, and submits completed worksheets. Involved in day-to-day laboratory testing and helps analysts as and when needed.
• Reviews method transfer protocols/reports/vendor qualifications reports/USP monograph evaluation reports/training records. Identifies training needs and provides necessary training to the analysts as and when needed.

Additional Responsibilities:

• Participates in analysis as and when required for special projects. When required, summarizes data for in-process testing, testing and release of finished products, and stability data for trending.
• Attends production planning meeting and updates list with delivery dates committed, track delivery dates with respect to committed dates. Submits a list containing weekly samples-in and out.

Qualifications

Education

• Bachelor's Degree (BA/BS) Chemistry or related technical field - Required
• Master's degree (MS/MA) Chemistry or related technical field - Preferred

Experience

• Bachelor's Degree with 7 years or more in Pharmaceutical Laboratory experience and 2 years or more in Supervisory experience.
• Master's Degree with 5 years or more in Pharmaceutical Laboratory experience and 2 years or more in Supervisory experience.

Specialized Knowledge

• Must possess in-depth knowledge of analytical chemistry techniques, such as spectrophotometric, dissolution and drug release, chromatographic techniques (standalone or hypenated) and measuring physical parameters (viscosity, particle size or droplet size by laser diffraction, melting point by DSC).Must be able to follow compendial (USP/EP/BP/JP) procedures for analysis.Must understand and apply cGMP requirements applicable to quality control laboratory.Must have ability to apply advanced technical skills to troubleshoot and resolve complex analytical and instrument-related problems effectively and in a timely manner and report actions to the laboratory management in a timely manner.Must be able to identify trends in analytical data.

The base salary for this position ranges from $80,000 to $110,000 per year. Amneal ranges reflect the Company’s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life’s many other commitments and opportunities.

About Us

Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at [e-mail] . Requests will be handled confidentially and in accordance with applicable laws.