QA Specialist Lot Release I (2nd Shift) jobs in United States
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Grand River Aseptic Manufacturing · 1 day ago

QA Specialist Lot Release I (2nd Shift)

Grand River Aseptic Manufacturing (GRAM) is dedicated to improving lives through quality systems in the manufacturing and testing of cGMP drug products. The QA Specialist Lot Release I will support quality operations, ensuring compliance and providing oversight for various quality documents and processes.

Pharmaceuticals
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H1B Sponsor Likelynote

Responsibilities

Verify compliance with terminal sterilization, visual inspection, labeling and packaging operations documentation during operations
Review executed batch records and other associated controlled documents
Perform QA review and approval of stability and finished products testing certificates of analysis
Understand and be able to perform job responsibilities in compliance with cGMPs, company standard operating procedures, and industry best practices
Participate in deviation investigation teams to support quality investigations (NCRs, LIRs etc.)
Creative and open-minded individual who fosters an environment in which sharing of ideas is encouraged
Demonstrates an understanding of the decision-making process and begin to build confidence in decision making ability

Qualification

QA principlesCGMP complianceBatch record reviewMicrosoft WordMicrosoft ExcelMicrosoft OutlookSoft skills

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 working in a pharmaceutical or other regulated 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

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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.

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 Stage

Leadership Team

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Nick Bykerk, CPA
Chief Financial Officer
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Bernie King
Chief Operating Officer
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Company data provided by crunchbase