QA Technician II - IPQA - Days

Work Schedule

12 hr shift/days

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

• •Collect completed Batch Production Record (BPR) packets from Encapsulation and Post-Production manufacturing areas and log receipt of records.
• •Perform timely, detailed reviews of BPRs throughout the assigned shift to verify completeness, accuracy, and compliance with cGMP requirements, SOPs, and Work Instructions.
• •Collect and review Gelatin and Medicine area production packets on weekends, as required, to support timely record review and product disposition.
• •Identify documentation discrepancies, missing information, or other compliance concerns and work with appropriate personnel to resolve issues.
• •Process the issuance of labels, bags, cartons, ink, and other applicable packaging components in SAP as part of the batch record review process.

• •Perform Quality Assurance sampling and inspection of finished products in accordance with established procedures and Acceptance Quality Level (AQL) requirements.
• •Collect samples at designated stages of production, including the beginning, middle, and end of a production run.
• •Perform and document required inspections according to approved AQL checklists and applicable procedures.
• •Submit completed inspection and sampling documentation for review and record retention.
• •Perform non-routine sampling and testing of products and materials when required, including random sampling based on customer or business requirements.
• •Conduct pre-shipment quality checks at the request of Batch Release or QA Management.

• •Collect required retain samples for each production lot.
• •Ensure retain samples are properly identified, documented, and transferred to the designated warehouse Retain Cage.
• •Retrieve and submit finished-product retain samples when requested.
• •Prepare and palletize retain samples for transfer to off-site warehouse storage, as needed.

• •Perform sample evaluations of bottled products received from contract packaging organizations.
• •Document evaluation results and submit completed evaluations and associated BPR documentation to Batch Release for review.

• •Print product labels in accordance with approved procedures.
• •Verify label information for accuracy and compliance before release.
• •Maintain printed labels in a secure, controlled location.
• •Issue approved labels to Packaging/Production personnel before packaging activities begin.
• •Maintain appropriate accountability and documentation for label issuance.

• •Initiate quality events in TrackWise and complete required supporting forms and documentation.
• •Issue controlled logbook numbers to Manufacturing.
• •Maintain completed logbooks in accordance with document-control requirements.
• •Retrieve archived or completed logbooks when requested.
• •Ensure quality documentation is complete, accurate, legible, traceable, and maintained according to applicable procedures and cGMP requirements.

Manufacturing & Operations Support

Provide day-to-day Quality Assurance support to Manufacturing and Packaging operations, including:

• •Addressing product quality and documentation questions.
• •Supporting QA Hold activities.
• •Observing and verifying manual weighing activities, as required.
• •Providing required QA approvals and sign-offs for packaging rooms and production activities.
• •Assisting with authorized computer or system access issues in accordance with established procedures.
• •Partnering with Operations personnel to resolve quality-related concerns while maintaining compliance and product quality.

Perform other reasonable quality-related duties as assigned to support business and operational needs.

• •Working knowledge of FDA current Good Manufacturing Practices (cGMP) applicable to pharmaceutical and/or nutritional manufacturing environments.
• •Ability to read, understand, interpret, and follow SOPs, Work Instructions, safety requirements, equipment instructions, and other controlled documents.
• •Strong attention to detail with the ability to identify documentation errors, inconsistencies, and potential compliance concerns.
• •Ability to accurately review and maintain controlled quality and manufacturing records.
• •Effective verbal and written communication sk