Work Schedule
12 hr shift/days
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job Description
Position Summary
The Quality Assurance (QA) professional is responsible for providing real-time quality support to manufacturing operations and reviewing Batch Production Records (BPRs) to ensure compliance with current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs), Work Instructions, and applicable regulatory requirements.
This position works closely with Manufacturing, Packaging, Batch Release, Warehouse, and other Quality functions to ensure accurate documentation, appropriate product sampling and inspection, and timely resolution of quality-related issues.
Key Responsibilities
Batch Production Record Review
- 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.
Finished Product Sampling & Inspection
- 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.
Retain Sample 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.
Contract Packaging Quality Support
- 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.
Label Control
- 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.
Quality Systems & Documentation
- 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.
Qualifications
To perform this position successfully, an individual must be able to carry out the essential responsibilities of the role while demonstrating appropriate standards of confidentiality, integrity, cooperation, professionalism, and respect for people and property.
Reasonable accommodations may be provided to enable qualified individuals with disabilities to perform the essential functions of the position.
Education & Experience
- Required: High school diploma, GED, or equivalent with at least six months of relevant experience;
- Preferred: Bachelor's degree with no prior related experience required; or
- An equivalent combination of education, training, and relevant experience.
1 year of experience in pharmaceutical, nutraceutical, dietary supplement, food, medical device, or other regulated manufacturing environments is required.
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
No specific professional certifications, licenses, or registrations are required.
Special Requirements
- Must meet all applicable DEA security clearance requirements.
- Must comply with site safety, security, quality, and regulatory requirements.
Physical Requirements
The physical requirements described below are representative of those necessary to perform the essential functions of the position. Reasonable accommodations may be provided for qualified individuals with disabilities.
The position may require employees to:
- 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.
Work Environment
This position operates in both Quality Assurance office and manufacturing environments.
Employees may periodically be exposed to:
- Wet or humid conditions.
- Moving mechanical equipment.
- Fumes or airborne particles.
- Chemicals or other potentially hazardous materials.
- Moderate to loud noise levels.
Employees are expected to follow all applicable Environmental Health and Safety (EHS) requirements and site-specific safety procedures.
Personal Protective Equipment (PPE)
Required PPE may include:
- Company-approved uniform or laboratory coat.
- Protective gloves.
- Safety glasses.
- Safety shoes.
- Hair protection.
- Hearing protection.
Additional PPE, including protective hoods or other specialized equipment, may be required for certain manufacturing areas or processes based on chemical and operational hazards.
Benefits
Eligible employees may receive a comprehensive benefits package that includes paid vacation, healthcare and dental coverage, and opportunities to participate in company stock programs, subject to applicable plan terms and eligibility requirements.