QA Specialist - Finishing Operations (2nd Shift)

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

7d • Onsite

About The Position

The QA Specialist I in Finishing Operations supports the quality systems as they relate to the manufacturing and testing of cGMP drug products. Provides quality oversight for terminal sterilization, visual inspection, labeling and packaging of parenteral drugs. Performs the quality release of incoming materials. Reviews documentation and quality records.

Requirements

• 1-2 years related work experience.
• In lieu of a bachelor’s degree, equivalent GMP/related work experience may be considered.
• Knowledge of QA principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
• Must have proficient computer skills in Microsoft Word, Excel, and Outlook.
• Must have basic computer skills such as Microsoft Word, Excel and Outlook.

Nice To Haves

• Bachelor’s degree in Life Sciences or related field
• Experience working in a pharmaceutical or other regulated environment.

Responsibilities

• Verify compliance with terminal sterilization, visual inspection, labeling and packaging operations documentation during operations.
• Review executed batch records and other associated controlled documents.
• Perform clearances and start-up activities associated with Finishing Operations and Weigh and Dispense Booth operation.
• Perform QA review and approval of stability and finished products testing certificates of analysis.
• Perform QA review and material release for incoming materials.
• Perform routine tasks within the quality systems, such as Work Orders, Calibration Forms, etc.
• Understand and be able to perform job responsibilities in compliance with cGMPs, company standard operating procedures, and industry best practices.
• Participate in deviation investigation teams to support quality investigations (NCRs, LIRs etc.).

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: Entry Level
• Education Level: Associate degree