Quality Assurance Manager
About The Position
The Quality Assurance Manager is responsible for operational and administrative duties that ensure quality assurance auditing at Tower Laboratories’ Montague facility operates effectively and efficiently and supports the company’s business objectives. The role supervises QA auditors, performs inspections and testing required for product release, supports manufacturing, communicates with internal and external customers, provides timely information, and ensures proper documentation. The position oversees packaging and incoming-component audits, investigations into product or process issues, internal GMP audits, onsite audits, and review of batch production documents and finished-product releases. It also coordinates packaging specifications and reviews and approves Bills of Materials. The role requires collaboration with manufacturing and cross-functional teams to identify and address deficiencies and root causes, while following safety, cGMP, and company procedures.
Requirements
- Five years of experience in Quality Assurance leadership in the pharmaceutical industry.
- Current knowledge of cGMP regulations and industry standards.
- Ability to train others and provide guidance.
- Strong teamwork skills and demonstrated team-oriented behaviors.
- Working knowledge of MS Word and MS Excel.
- Strong writing skills.
- Excellent organizational skills and ability to delegate.
- Strong attention to detail.
- Strong problem-solving and analytical skills.
Nice To Haves
- Bachelor’s degree in Science preferred; equivalent experience in Quality Assurance in the pharmaceutical industry may be substituted.
Responsibilities
- Oversee daily activities of QA auditors, provide direction and guidance, and arrange necessary training.
- Conduct packaging audits to confirm finished products meet packaging specifications and accepted quality limits (AQL).
- Inspect incoming packaging components and perform appropriate tests to verify they meet specifications.
- Lead or conduct investigations and gather information to assess root causes when products or processes do not meet specifications.
- Conduct internal GMP audits to ensure compliance with cGMP and internal procedures and policies.
- Participate in, lead, or co-lead onsite audits.
- Audit completed batch production documents and release finished product.
- Communicate manufacturing deficiencies to relevant personnel, including machine operators, the Quality Manager, and Production Supervisors.
- Work with cross-functional teams to determine and correct root-cause issues.
- Coordinate packaging specifications and review and approve Bills of Materials (BOM).
- Perform work in accordance with safety, cGMP, and company procedures and support the company mission and values.
- Carry out other responsibilities as assigned.
Benefits
- Medical insurance
- HSA option
- Dental insurance
- Vision insurance
- Accident, critical illness, and hospital indemnity insurance
- Voluntary life insurance
- Company-paid life insurance
- Long-term disability coverage
- 401(k) with an employer contribution of up to 3%
- Paid time off
- Sick time
- 9 paid holidays
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What This Job Offers
Job Type
Full-time
Career Level
Manager
