QA Technician II - IPQA - Days

Knowledge, Skills & Abilities

• 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 skills.
• Ability to communicate quality requirements and present information effectively in one-on-one and small-group settings.
• Ability to respond professionally to questions from associates, leads, supervisors, and other cross-functional partners.
• Ability to follow written, verbal, and diagram-based instructions and apply sound judgment to standardized situations.
• Ability to identify and resolve problems involving multiple concrete variables within established procedures and requirements.
• Ability to perform basic mathematical calculations involving whole numbers, fractions, decimals, ratios, rates, and percentages and to interpret basic graphs.
• Proficiency with Microsoft Office and Windows-based applications.
• Experience using SAP or similar enterprise resource planning (ERP) systems.
• TrackWise experience is preferred.
• Ability to work effectively in a fast-paced manufacturing environment while managing multiple priorities and maintaining accuracy and compliance.

Certificates, Licenses & Registrations

• Must meet all applicable DEA security clearance requirements.
• Must comply with site safety, security, quality, and regulatory requirements.

Physical Requirements

• Communicate effectively with others in person and within a manufacturing environment.
• Stand and walk for extended periods.
• Frequently bend or stoop.
• Regularly reach with hands and arms and perform tasks requiring manual dexterity.
• Regularly lift, carry, push, or pull items weighing up to 10 pounds.
• Occasionally lift, carry, push, or pull items weighing up to 50 pounds.
• Have sufficient close, color, peripheral, and depth vision to perform required inspections and quality-related activities.

Finished Product Sampling & Inspection

1. 6Perform Quality Assurance sampling and inspection of finished products in accordance with established procedures and Acceptance Quality Level (AQL) requirements.
2. 7Collect samples at designated stages of production, including the beginning, middle, and end of a production run.
3. 8Perform and document required inspections according to approved AQL checklists and applicable procedures.
4. 9Submit completed inspection and sampling documentation for review and record retention.
5. 10Perform non-routine sampling and testing of products and materials when required, including random sampling based on customer or business requirements.
6. 11Conduct pre-shipment quality checks at the request of Batch Release or QA Management.

Retain Sample Management

1. 12Collect required retain samples for each production lot.
2. 13Ensure retain samples are properly identified, documented, and transferred to the designated warehouse Retain Cage.
3. 14Retrieve and submit finished-product retain samples when requested.
4. 15Prepare and palletize retain samples for transfer to off-site warehouse storage, as needed.

Contract Packaging Quality Support

1. 16Perform sample evaluations of bottled products received from contract packaging organizations.
2. 17Document evaluation results and submit completed evaluations and associated BPR documentation to Batch Release for review.

Label Control

1. 18Print product labels in accordance with approved procedures.
2. 19Verify label information for accuracy and compliance before release.
3. 20Maintain printed labels in a secure, controlled location.
4. 21Issue approved labels to Packaging/Production personnel before packaging activities begin.
5. 22Maintain appropriate accountability and documentation for label issuance.

Quality Systems & Documentation

1. 23Initiate quality events in TrackWise and complete required supporting forms and documentation.
2. 24Issue controlled logbook numbers to Manufacturing.
3. 25Maintain completed logbooks in accordance with document-control requirements.
4. 26Retrieve archived or completed logbooks when requested.
5. 27Ensure quality documentation is complete, accurate, legible, traceable, and maintained according to applicable procedures and cGMP requirements.

Manufacturing & Operations Support

1. 28Addressing product quality and documentation questions.
2. 29Supporting QA Hold activities.
3. 30Observing and verifying manual weighing activities, as required.
4. 31Providing required QA approvals and sign-offs for packaging rooms and production activities.
5. 32Assisting with authorized computer or system access issues in accordance with established procedures.
6. 33Partnering with Operations personnel to resolve quality-related concerns while maintaining compliance and product quality.

Environmental Conditions

• Wet or humid conditions.
• Moving mechanical equipment.
• Fumes or airborne particles.
• Chemicals or other potentially hazardous materials.
• Moderate to loud noise levels.