QA Supervisor - Finishing

Grand River Aseptic Manufacturing, Inc. • Grand Rapids, MI

4d

About The Position

The QA Supervisor provides direction and leadership to the Grand River Aseptic Manufacturing (GRAM) Quality Systems with oversight Finishing Operations (Inspection, Labeling, Packaging). This position works closely with all levels of the Operations, Technical Services, Validation, QC (Microbiology and Analytical Chemistry), Business and Finance teams.

Requirements

• Bachelor’s degree in Life Sciences or a related field and/or a minimum of 4+ years related work experience.
• At least 3 years prior experience in a QA Specialist role.
• A thorough understanding of cGMP, FDA guidelines and multinational regulatory standards.
• Must have proficient computer skills in Microsoft Word, Excel, and Outlook.

Nice To Haves

• Prior leadership experience.
• Prior experience interacting with regulatory authorities.
• Experience and expertise in aseptic manufacturing of regulated products.

Responsibilities

• Provide supervision to Quality Specialists and Quality Technicians of various levels. Responsibilities include managing, motivating, coaching and mentoring.
• Ensure Quality support and oversight of Finishing operations across all shifts, including occasional weekend support.
• Oversight and management of the batch record review and final release processes.
• Client support / interaction related to these processes.
• Interface with auditors, including client representatives and regulatory agencies.
• Perform Quality Assurance review and approval of cGMP documentation in support of continuous improvements, including Procedures; Test Methods; Master Batch Records; Risk Assessment Reports

Benefits

• Medical, prescription, dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying a portion of the cost!
• Once eligible for the 401(k) program, all your contributions are immediately 100% vested, and you are immediately vested in GRAM contributions as well.
• Generous off-shift premiums!
• 16 hours of paid volunteer time per calendar year!
• Full-time employees accrue up to 13 days of time off per calendar year. You choose how to use this time for your vacation, sick, or mental health needs!
• Employees earn 1 hour of time off for every 30 hours worked to use how you choose.
• 10 paid holidays per calendar year with immediate eligibility!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level