Grand River Aseptic Manufacturing · 13 hours ago
QA Specialist III Lot Release (1st Shift)
Grand Rapids,MI,US
Full-time
Onsite
Entry, Mid Level
1+ years expGrand River Aseptic Manufacturing (GRAM) is a company dedicated to improving lives through their quality systems in the pharmaceutical industry. The QA Specialist III Lot Release role involves supporting the release of commercial drug lots and conducting batch record reviews, while leading continuous improvement efforts aligned with GRAM's core values.
Pharmaceuticals
Responsibilities
Review and approve controlled documents to support compliant operation of QA Lot Release department and Finishing operations
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
Revise and monitor the redline system and update documents in MasterControl as needed
Perform transactions in QAD as required to support finished product release functions
Perform QA Drug Product Batch Release, CoC Generation, CoA review/approval 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 accordingly on time
Qualification
Required
Bachelor's degree in Life Sciences or related field, and 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
Preferred
Experience and expertise in aseptic manufacturing of regulated products with a thorough understanding of cGMP, FDA guidelines and multinational regulatory standards is preferred
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.
We also offer generous off-shift premiums!
GRAM encourages giving back to our community by offering 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.
We offer 10 paid holidays per calendar year with immediate eligibility!
Company
Grand River Aseptic Manufacturing
Grand River Aseptic Manufacturing (GRAM) is a leading contract development and manufacturing organization (CDMO) specializing in sterile injectable fill-and-finish services for liquid and lyophilized vials, syringes, and cartridges.
201-500 employees
H1B Sponsorship
Grand River Aseptic Manufacturing has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2023 (2)
Funding
Current Stage
Growth StageLeadership Team
Nick Bykerk, CPA
Chief Financial Officer
Bernie King
Chief Operating Officer
Company data provided by crunchbase