Quality Assurance Manager in Montague, Michigan at TOWER LABORATORIES LTD.

POSITION SUMMARY:

Responsible for the operational and administrative duties needed to ensure that the Quality Assurance auditing in the Montague facility operates effectively and efficiently and is fully integrated with Tower Labs’ business objectives. This includes supervising auditor(s), performing necessary inspection and testing required for product release, supporting the manufacturing operation, providing timely information and communicating with both internal and external customers. This position also has responsibilities with proper documentation.

ESSENTIAL FUNCTIONS:

• Oversee daily activities of QA Auditor(s); providing direction of responsibilities and guidance for completing tasks as well as providing any necessary training.
• Familiar with FDA rules, regulations and understanding of FDA processes.
• Conduct packaging audit, ensuring final product meets packaging specifications and is within the allowed accepted quality limits (AQL); inspect all incoming packaging components, ensuring specifications are met by performing appropriate tests following determined component specifications.
• Lead and conduct investigations, as directed, and collect information to assess root causes when product or processes are not meeting specifications.
• Conduct internal GMP audits to ensure compliance to cGMP and internal procedures and policies.
• Participate in, lead and/or co-lead all audits conducted onsite.
• Audit finished/completed batch production documents and release of finished product.
• Communicate identified manufacturing deficiencies to key personnel (Machine Operator, Quality Manager, Production Supervisor etc.).
• Work with cross functional team to determine and correct root cause issues.
• Coordinate packaging specifications; review and approve Bill of Materials (BOM).
• Perform all work in accordance with established Safety, cGMP and company procedures; support company mission and values.
• Other responsibilities as assigned.

ESSENTIAL SKILLS and EXPERIENCE:

• Five years experience in Quality Assurance leadership in the pharmaceutical industry.
• Demonstrated current knowledge of cGMP regulations and industry standards.
• Ability to train others and provide guidance.
• Strong team player, demonstrated team attitude and behaviors.
• Working knowledge of MS Word and MS Excel.
• Strong writing skills.
• Excellent organizational skills; ability to delegate.
• Strong attention to detail.
• Strong problem-solving and analytical skills.

EDUCATION:

Bachelor’s degree in Science preferred; equivalent experience in Quality Assurance in the pharmaceutical industry may be substituted.

BENEFITS AND SALARY INFORMATION:

Full-time employees are eligible for the following benefits after meeting any applicable waiting periods:

• 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, and 9 paid holidays