Grand River Aseptic Manufacturing · 1 week ago
QA Specialist II - Supplier Quality
Grand Rapids,MI,US
Full-time
Onsite
Entry, Mid Level
2+ years expGrand River Aseptic Manufacturing (GRAM) is dedicated to improving lives through high standards and a disciplined approach to quality. They are seeking a QA Specialist II to ensure that materials and services from suppliers meet all regulatory and quality standards, supporting supplier qualification and resolving related issues.
Pharmaceuticals
Responsibilities
Develop and implement supplier quality programs and procedures
Conduct routine supplier audits and risk assessments
Lead investigations for supplier non-conformances
Manage supplier corrective and preventive actions (CAPAs)
Monitor supplier performance metrics and trends
Evaluate and approve supplier changes or requalifications
Collaborate with cross-functional teams on material issues
Review and provide final disposition of materials
Qualification
Required
Bachelor's degree in technical field
A minimum of 2 years' experience in a regulated environment
Working knowledge of cGMP, ISO, ICH, CFR, FDA and EU regulations
Experience with root cause analysis tools (e.g.,5 Whys, Fishbone)
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.
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