QA Auditor / Inspector
The Quality Assurance/Inspector is primarily responsible for auditing manufacturing operations and quality systems for compliance with Good Manufacturing Practices, Good Documentation Practices, Standard Operating Procedures and other quality policies established by Wellington Foods, Inc. He/she performs inspection functions to verify that products conform to specifications. She/he monitors processes and provides support to Manufacturing Operations, and assists management in identifying and reporting non-conformance issues and trends.
The position reports to the Quality Assurance Supervisor and/or Quality Assurance Manager.
DUTIES & RESPONSIBILITIES:
- Enforce adherence to Current Good Manufacturing Practices (cGMPs) and Good Documentation Practices (GDPs) at all stages of the manufacturing processes and in all places within the manufacturing areas.
- Perform and document a wide variety of inspections, checks, tests and sampling procedures during the manufacturing process.
- Monitor all aspects of the manufacturing operations and conduct routine “walk-through” in the manufacturing areas and other specified areas (such as restrooms, and break-rooms) to ensure that good housekeeping practices, good hygiene practices, pest control, etc. which could affect the safety and quality of manufactured products, are followed.
- Verify that all raw materials and packaging components are properly received, stored and segregated (allergen vs. non-allergen; organic vs. non-organic, etc.) in the warehouse for raw materials and packaging components.
- Verify that processing equipment have been properly cleaned and sanitized in staging rooms, compounding/batching rooms, powder blending rooms, filling and packaging rooms, etc.
- Audit the weighing/staging process to ensure that the correct raw materials are used and in correct amounts as specified in the Ingredients Batch Record.
- Audit the compounding/batching process to ensure that all raw materials allocated to the batch are added to the batch and in the sequence specified in the Manufacturing Instructions Batch Record.
- Collect in-process samples from the batch (as specified) and perform all required tests (pH, Brix, sensory evaluation, etc.) before releasing the batch for further processing (such as thermal processing) and packaging.
- Collect samples of finished products (test samples, stability samples, and reserve samples), conduct specified testing and report testing results.
- Perform line/area clearance for removal of all previous products, components and foreign materials. Approve work area for readiness prior to use.
- Maintain all quality and production paperwork including bottle and cap tracking logs, shrink sleeve tracking logs, area line clearances, room and equipment cleaning and sanitation, issuing of product specification sheets, etc.
- Perform reconciliation and closing of batch records, and review documentation to assure accuracy and completeness.
- Verify that all quality control instruments (balances, pH, refractometers, thermometers, etc.) are properly calibrated and performing up to specifications.
- Collect samples of finished products for quality control laboratory, special testing such as stability studies, customer samples and maintain reserve samples.
- Monitor the effectiveness of cleaning & sanitation (visual observation as well as using ATP bioluminescence method).
- Assist in environmental monitoring (equipment and surface swabbing, and air sampling) and pest control inspection.
- Assist in training new inspectors on proper documentation and inspection.
- Assist management in conducting inquiries and investigation.
- Perform other duties as determined by the Quality Systems & Regulatory Compliance Department Management.
REQUIRED EDUCATION / WORK EXPERIENCE / SKILLS:
- Bachelor’s degree in food science and technology, biology, microbiology or other related disciplines or equivalent combination of education and work experience (such a high school diploma with at least 3 years of work experience in related field or industry).
- Work experience in quality control/quality assurance operations in food, dietary supplement or pharmaceutical industry.
- Experience with GMP regulations and Good Documentation Practices.
- Ability to work independently and in a team environment. Ability to follow instructions.
- Good attendance and punctuality.
- Attention to details and ability to work effectively in a fast-paced environment.
- Extended hours in standing and/or walking position
- May be required to regularly lift up to 25 pounds (lbs) of materials
Our company is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression, or any other basis protected by local, state or federal law.
This policy applies with regard to all aspects of one’s employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.