Sr QA Specialist

This role is 100% on-site in South New Jersey. Only local candidates will be considered.

About the role

The Quality Assurance Specialist ensures compliance with all regulatory requirements, current Good Manufacturing Practices (cGMP), and company Policies, Standard Operating Procedures, and Work Instructions.

Responsibilities

• Reviews, approves, and tracks executed production records.
• Reviews and approves production and QC investigations.
• Reviews lab sample results and manufacturing records related to qualification/validation activities.
• Conducts, writes, and reviews quality-related investigations as appropriate.
• Reviews and approves Master Production Records.
• Ensures cGMP compliance of assigned manufacturing operations/areas.
• Completes QMS items as assigned.
• Responsible for the conditional/final release of materials.
• Hosts customer and internal audits, as needed.
• Conducts internal and external audits, as needed.
• Participates in inspections by regulatory authorities.
• Writes and reviews Annual Product Reviews/Product Quality Reviews.
• Writes and reviews Product Validation/Qualification/Assessments documents.
• Writes and reviews Equipment Qualifications/Assessments documents.
• Writes and reviews Computerized Systems Validations/Assessments documents.
• Reviews, evaluates, and approves minor equipment changes.
• Conducts GMP inspections.
• Conducts environmental monitoring.
• Reviews and approves CMC sections of DMFs as appropriate.
• Maintains QA databases for products/equipment as appropriate.
• Adheres to personal moral, ethical, legal, and behavioral conduct in compliance with the Code of Conduct.
• Adheres to all applicable SHE and cGMP regulations (e.g., ICH Q7, FDA, 21 CFR 210 and 211).

Requirements

• BA/BS degree in microbiology, biology, chemistry, or engineering.
• 3-5 years of experience in QA within a pharmaceutical manufacturing environment, or an equivalent combination of education and experience.
• Thorough knowledge of cGMP in active pharmaceutical ingredient (API) manufacturing is preferable.
• Excellent communication skills.
• Conscientious and detail-oriented.
• Proficient in MS Office 365.
• Ability to work in a team environment.
• Strong self-management and prioritization skills.
• Ability to manage projects and meet deadlines.

Benefits

• Medical, dental, vision, life, and disability insurance plans.
• Employee Stock Purchase Program (ESPP).
• 401K program with company match after 12 months of tenure.
• Health Savings Account (HSA) on the HDHP plan.
• SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions.
• Corporate discount savings program and other discounts.
• On-demand training program.
• Access to certification prep, technical and leadership courses/books/seminars after 6+ months of tenure.
• Certification discounts and perks for associations (e.g., CompTIA, IIBA).
• Dedicated customer service team for benefits and resources.
• Access to a certified Career Coach.