Quality Assurance Associate
3 days ago
We are seeking a highly motivated and detail-oriented Quality Assurance Associate to join our team at American Regent, Inc. This role is responsible for ensuring the overall quality of our products and processes, ensuring compliance with regulatory requirements and company policies.
Key Responsibilities- Conduct regular inspections and verifications to ensure compliance with cGMP requirements and company policies.
- Identify and escalate any out-of-specification products or processes.
- Perform packaging and inspection room clearance qualifications.
- Conduct component and raw material releases.
- Support product shipping activities and perform quality-related oversight and verifications.
- Generate logbooks and sheets/labels.
- Review Bills of Materials.
- Participate in Media Fill and maintain qualification.
- High School Diploma or GED equivalent required; Associates or Bachelor's Degree preferred.
- Minimum 1 year work experience in a FDA-regulated environment or similarly regulated area is preferred.
- Must be able to work independently and as part of a team.
- Intermediate skills in Microsoft Word and Excel are required.
- Excellent organizational, interpersonal, and communication skills (written and oral) are required.
- Physically able to wear cleanroom/protective gowning and equipment.
- Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.
- Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
- Employee must be able to occasionally lift and/or move up to 25 pounds.
American Regent, Inc. celebrates diversity and is committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
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