Associate Specialist, Quality Assurance
About The Position
Without compromising our steadfast commitment to Quality, Safety and Sustainability our manufacturing and packaging facility produces in excess of 70MM units per year. This is a demonstration of our can-do attitude, collaborative spirit, focus on innovation and continuous improvement mindset. Always People First! JOB SUMMARY The Quality Assurance Associate Specialist is responsible for preparing and completing the CARES act report for FDA, is responsible for BOM review and approval, Bulk and Finished Good, Responsible for Releasing Finished Goods (OTC, Non-OTC etc.) reviewing Batch records, specifications, procedures, protocols, and records for GMP compliance.
Requirements
- You have a bachelor’s degree (B. A.) from a four-year college or university, preferably in Engineering or Science
- You have two years’ knowledge of pharmaceutical GMP documentation requirements and quality assurance experience in a regulated industry.
- You have a good understanding of 21CFR (Part210-211), ICH guidelines
- You have experience with SAP systems
- You are an expert in Excel and PowerPoint presentation.
- You have good verbal and written communication skills
Responsibilities
- Prepare and complete the CARESS ACT list for FDA.
- Complete BOM review and approval, set up the system specifications for Finished Goods, FG, and Bulk working closely with different departments
- Responsible for Releasing Finished Goods (OTC, Non-OTC, etc.)
- Prepare master production records for all OTC products.
- Review raw material, packaging material, in-process material and finished product specifications for GMP compliance – Reconciliation of OTC Batch Records.
- Perform review of Production batch records and control records for OTC products and initiate investigation for any unexplained discrepancy found during review. Prepare Certificate of Manufacturing and Compliance and release OTC products for shipment.
- Aid in investigations as required.
- File and maintain batch production and control records for OTC product.
- Conduct/review Annual Product Review of OTC products. Record the observations that needs follow up with AIC team.
- Provide GMP Training to other departments as needed
- Research and prepare data as needed for monthly quality metrics reporting
- Assist in any projects/tasks assigned by the Manager.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
