Pharmaceutical Quality Associate

Job Description

Job Description

Description:

GENERAL SUMMARY :

A member of the Quality Assurance (QA) team for a veterinary pharmaceutical manufacturing company. Responsible for coordinating, preparation and issuance of all manufacturing, packaging and testing documents for scheduled production and for maintenance of the Master Batch Records. Responsible for the review of all in process and finished product lot documentation to ensure compliance with cGMP, SOP and FDA regulations for release of product. Responsible for data entry and trending of all in process, finished product and manufacturing data per product for use in investigations, monthly management reviews, annual product reviews. To provide recommendations, resolutions and take appropriate action to ensure compliance. As required, backs up QA line personnel performing quality checks and documentation review.

PRIMARY RESPONSIBILITIES:

• Determines and selects appropriate master documents, test specification and worksheets for assembly and preparation of complete and accurate production batch records.
• Calculates and assigns expiration date 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.
• Assists 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.
• Leads special projects as requested by management.

QUALIFICATIONS:

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.
• Basic knowledge of Microsoft Office (Word, PowerPoint, Excel, Outlook) required.

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

Please note this job posting is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

FLSA: Non-Exempt