Associate Specialist, Quality Assurance

Job Summary

The Quality Assurance Associate Specialist is responsible for preparing and completing the CARES act report for FDA, completing BOM review and approval, setting up system specifications for Finished Goods, releasing Finished Goods (OTC, Non-OTC etc.), reviewing Batch records, specifications, procedures, protocols, and records for GMP compliance.

What You Will Do

• You will prepare and complete the CARES act list for FDA.
• You will complete BOM review and approval, set up the system specifications for Finished Goods, FG, and Bulk working closely with different departments.
• You will be responsible for Releasing Finished Goods (OTC, Non-OTC, etc.).
• You will prepare master production records for all OTC products.
• You will review raw material, packaging material, in-process material and finished product specifications for GMP compliance – Reconciliation of OTC Batch Records.
• You will 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.
• You will aid in investigations as required.
• You will file and maintain batch production and control records for OTC product.
• You will conduct/review Annual Product Review of OTC products. Record the observations that needs follow up with AIC team.
• You will provide GMP Training to other departments as needed.
• You will research and prepare data as needed for monthly quality metrics reporting.
• You will assist in any projects/tasks assigned by the Manager.

Who You Are

• 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.

Physical Requirements

• Standing: Under 1/3
• Walking: Under 1/3
• Sitting: Over 2/3
• Use hands to finger, handle or feel: Not Applicable
• Climb or balance: Under 1/3
• Reach with hands and arms: Under 1/3
• Stoop, kneel, crawl: Not Applicable
• Up to 10 pounds: Under 1/3
• Up to 25 pounds: Under 1/3
• Up to 50 pounds: Not Applicable
• Up to 100 pounds: Not Applicable

Qualifications

• 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.

Skills

• Expertise in Excel and PowerPoint presentation.

Benefits

• Not specified

Pay

• $65,992 - $90,739/year

Schedule

• Not specified