Note: The job is a remote job and is open to candidates in USA. Grand River Aseptic Manufacturing (GRAM) is a pharmaceutical manufacturing company focused on improving lives through science-based, high-quality operations. The QA Specialist I supports quality systems for cGMP drug products by providing oversight of finishing operations, reviewing documentation and quality records, releasing materials, and supporting quality investigations.
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 clearances and start-up activities associated with Finishing Operations and Weigh and Dispense Booth operation
- Perform QA review and approval of stability and finished products testing certificates of analysis
- Perform QA review and material release for incoming materials
- Perform routine tasks within the quality systems, such as Work Orders, Calibration Forms, etc
- 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.)
Skills
- 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
- Must have basic computer skills such as Microsoft Word, Excel and Outlook
- Bachelor's degree in Life Sciences or related field
- 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.
- Generous off-shift premiums.
- 16 hours of paid volunteer time per calendar year, starting day 1.
- Full-time employees accrue up to 13 days of time off per calendar year, usable for vacation, sick, or mental health needs.
- Employees earn 1 hour of wellness time off for every 30 hours worked, to use how they choose.
- 10 paid holidays per calendar year with immediate eligibility.
Company Overview
Company H1B Sponsorship