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Job Description
Simtra BioPharma Solutions is seeking a Quality Associate I to join their Quality Assurance Line Operations Team. This role involves maintaining quality oversight of manufacturing areas, working closely with manufacturing personnel, and performing checks during manufacturing processes. The Quality Associate also assesses regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Simtra Standard Operating Procedures. Simtra values teamwork, productivity, and safety to improve patient health.
Responsibilities:
- Ensuring compliance with regulatory requirements and company regulations.
- In-process review of records to ensure accuracy and compliance.
- Reporting errors and providing direction to halt operations if product safety is compromised.
- Performing quality functions in classified areas and conducting facility inspections.
- Initiating nonconformance reports and CAPAs, and revising SOPs as needed.
Requirements:
- BS degree (science discipline preferred) or AS degree with 1+ year of Pharmaceutical experience, or no degree with 2+ years of Pharmaceutical experience.
- Working knowledge of FDA CFR 210, 211 and GDP.
- Proficiency in MS Office Suite and ability to use enterprise software.
Simtra offers:
- Day One Benefits including Medical & Dental Coverage.
- Flexible Spending Accounts, Life and AD&D Insurance.
- 401(k) Retirement Savings Plan with Company Match.
- Time Off Program - Paid Holidays, Paid Time Off, Paid Parental Leave.
- Adoption Reimbursement Program and Education Assistance Program.
