Quality Assurance Team Lead

3 weeks ago


Grand Rapids, Michigan, United States Grand River Aseptic Manufacturing Full time
Job Title: Quality Assurance Team Lead

Grand River Aseptic Manufacturing is seeking a highly skilled Quality Assurance Team Lead to support our quality systems and lead continuous improvement efforts in our QA Lot Release department.

Key Responsibilities:
  • Perform QA drug product batch release, CoC/CoQ generation, CoA review, and associated data entry.
  • Provide sound quality and technical inputs to continuous improvement projects to ensure all project-related deliverables are aligned with and delivered on time.
  • Review and approve controlled documents to support compliant operation of QA Lot Release department.
  • Collaborate and communicate with clients and other departments in the research, development, implementation, and support/troubleshooting of new and existing Laboratory Application Systems and electronic batch record systems.
  • Lead the MBR redline program (revise and monitor redlines, update documents in MC as needed).
  • Provide any support required to support on-time batch record review and closure.
  • Interact with customers to support client initiatives.
Requirements:
  • High School Diploma and 5+ years of experience in pharmaceutical or GMP manufacturing.
  • Knowledge of QA principles and procedures in a pharma, biopharma, medical device, or biotech manufacturing environment.
  • Proficient computer skills in Microsoft Word, Excel, and Outlook.
  • Preferred requirements: experience and expertise in aseptic manufacturing of regulated products with a thorough understanding of cGMP, FDA guidelines, and multinational regulatory standards.
What Sets GRAM Apart:
  • Medical benefits starting day 1: Blue Cross Blue Shield medical and dental, vision, life insurance, and disability benefits are available to you and your family on your first day of work, with the company paying for 75% 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.
  • Paid volunteerism starting day 1: GRAM encourages giving back to our community by offering 16 hours of paid volunteer time per calendar year.
  • PTO: Full-time employees accrue up to 17 days of time off per calendar year.
  • Wellness time off: We offer all employees one (1) paid day of Wellness Time Off (WTO) per quarter to invest in self-care, take some downtime, or whatever you choose.
  • PAID HOLIDAYS: We offer 10 paid holidays per calendar year with immediate eligibility.


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