Pharmaceutical Quality Associate

Primary Responsibilities

• Determines and selects appropriate master documents, test specifications and worksheets for assembly and preparation of complete and accurate production batch records.
• Calculates and assigns expiration dates for each scheduled product.
• Administers the issuance of all necessary documents for each scheduled product; assures and verifies critical information such as lot number and expiration date.
• Develops appropriate batch records to meet the documentation requirements of validation protocols, special studies, and component qualification.
• Performs thorough review of production batch records, cleaning, laboratory testing documentation, etc. and forwards production batches to the QA Supervisor for final release ensuring release timelines are met.
• Works with Operations and Quality personnel to correct identified deficiencies to ensure timely release of batches.
• Generates Certificates of Analysis and Compliance for each production lot.
• Generates Minitab Charts for In-Process and Finished Product using Minitab Statistical Software.
• Reviews and releases incoming raw materials.
• Tracks batch release performance metrics and provide to compliance for inclusion in management review meetings and product reviews.
• Affords assistance in the review and revision of SOPs, protocols, and special studies required for compliance with batch records.
• Ensures all batch record and specification sheet maintenance, issuance, revision, and review SOPs remain compliant with FDA expectations and reflect current First Priority practices.
• Controls and maintains the current files for all master batch records, test methods, and specification sheets required for manufacturing, packaging, and testing.
• Performs API calculations per the batch record requirements.
• Issue OOS No., NIDR No, QA Hold Notification and maintain electronic log and logbook.
• Reviews Brite Stock packets.
• Assists, as needed, performing QA Specialist tasks on manufacturing lines.
• Assists in Label Room as necessary.
• Led special projects as requested by management.

Requirements

• Education and/or Experience: Bachelor’s Degree with 0-2 years’ work experience or High School degree with 4+ years’ experience in pharmaceutical quality with experience in documentation review.
• Training: On the job training: Good Manufacturing Practices (GMP) Quality Assurance Procedures.
• Work Environment: Office environment Occasional work in light manufacturing environment Working independently with minimal supervision Low to medium noise level Temperature controlled environment.
• Tools and Equipment: Microsoft Office Quality Management Systems Program Copy Machine Calculator.