Location: all cities,MI, USA
Description Quality, Service, Collaboration, Courage. Do you exhibit these values and wish to be around others that do too? Are you interested in making a difference in your community and the world? Are you looking for a place where you can grow and learn in a diverse, community-minded culture? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day. Overview of this Position: The Team Lead of the QA Lot Release team supports quality systems as they relate to the release of commercial drug lots and finishing batch record review. These duties include, but are not limited to, the release of drug products, CoC/CoQ Generation, and CoA review. Support and lead continuous improvement efforts to support lot release activities. Non-Negotiable 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 is required. Must have 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 is preferred. Prior experience managing projects. Responsibilities Include (but are not limited to): Perform QA Drug Product Batch Release, CoC/CoQ Generation, CoA review and associated data entry. Provide sound quality and technical inputs to the continuous improvement projects to ensure all project-related deliverables are aligned with and delivered according 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. Perform tasks within the quality systems with a demonstrated understanding of the correlation between 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. Full job description available during formal interview process. What Sets GRAM Apart from Other Employers: 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. We also offer generous off-shift premiums 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. You choose how to use this time for your vacation, sick, or mental health needs 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 PAY: Depends on Experience and is discussed during the interview process. If you meet the required criteria listed above, GRAM welcomes you to apply today