Grand River Aseptic Manufacturing · 19 hours ago
QA Specialist Aseptic Operations (1st, 2nd, 3rd, Weekend Days, Weekend Nights)
Grand Rapids,MI,US
Full-time
Onsite
Entry, Mid Level
2+ years expGrand River Aseptic Manufacturing (GRAM) is dedicated to improving lives through quality assurance in drug manufacturing. The Quality Assurance Specialist supports quality systems related to cGMP drug products, overseeing aseptic processes, batch record reviews, and quality management systems.
Pharmaceuticals
Responsibilities
Provide on the floor Quality oversight within the warehouse and manufacturing areas to support compliance with procedures and manufacturing documentation during operations with minimal guidance
Establish and maintain good technique with regards to working in classified areas (including gowning qualification)
Review and approve executed batch records and other associated controlled documents
Perform QA review in-process, environmental monitoring test results, and material release for incoming materials
Participate in cross functional teams to support quality investigations
Perform tasks within the quality systems with an understanding of the correlation between systems, such as the relationship between a deviation and CAPA
Qualification
Required
Bachelor's degree in Life Sciences or related field, and 2-5 years related work experience. In lieu of a bachelor's degree, equivalent GMP/related work experience may be considered
Ability to complete tasks with accuracy and efficiency
Proficient computer skills in Microsoft Word, Excel, and Outlook
Preferred
Knowledge of quality assurance principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment
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