The Quality Assurance Specialist supports the Quality Managerin maintaining Aspen Co-Pak’s compliance with cGMP, FDA (21 CFR 111/117),NSF/455-2, Organic, Kosher, and customer quality requirements. This position isresponsible for documentation control, MMR creation and review, specificationsmanagement, COA verification, environmental monitoring, internal auditing, andsupporting quality programs such as CAPA, complaints, and supplier approval.The QA Specialist ensures accurate records, strong GMP compliance, andeffective execution of key quality system processes.
Job Duties
- Create, review, revise, and maintain:
- Master Manufacturing Records (MMRs)
- Product Specifications (raw material, bulk, finished product)
- SOPs, logs, forms, and controlled documents
- Maintain document control system, ensuring proper version control and distribution.
- Support the development and improvement of quality system procedures.
- Receive, review, and verify Certificates of Analysis (COAs) for raw materials, premixes, bulk products, and finished goods.
- Ensure COA compliance with internal specifications and customer requirements.
- Submit samples to third-party laboratories, track testing results, and maintain testing logs.
- Maintain retain samples as required by procedure.
- Execute the Environmental Monitoring Program (swabs, ATP, air/water sampling).
- Document and trend EMP results; report any deviations.
- Conduct internal audits per schedule; document findings and follow up on corrective actions.
- Assist in external audits (customer, regulatory, certifying bodies).
- Assist with CAPA investigations, root cause analysis, corrective/preventive action implementation, and verification.
- Support customer complaint investigations, documentation, and corrective action follow-up.
- Maintain the Supplier Approval Program by collecting documents, verifying certifications, and updating files.
- Participate in traceability exercises, mock recalls, and emergency management drills.
- Support hazard analysis and risk assessments for processes and materials.
- Support GMP compliance through floor checks, gowning verification, documentation reviews, and hygiene monitoring.
- Work with warehouse software such as Data Ninja to verify inventory, lot tracking, and FIFO compliance.
- Collaborate with production and warehouse teams to ensure adherence to SOPs and quality standards.
- Perform other duties as assigned by the Quality Manager.
Required Skills
- Has strong knowledge and skills associated with Quality Assurance systems and procedures in food and dietary supplement manufacturing
- Strong understanding of cGMP and FDA regulations (21 CFR 111/117).
- Ability to read, interpret, and create technical documents (MMRs, specs, COAs, SOPs).
- Excellent documentation, organization, and recordkeeping skills.
- Proficiency in Microsoft Excel, Word, and PDF editing tools.
- Ability to use or learn warehouse/data systems such as Data Ninja.
- Strong attention to detail, accuracy, and problem-solving skills.
- Effective communication skills (written and verbal).
- Ability to work independently and in a team environment.
- Strong time-management and multitasking abilities.
- Communicates effectively and professionally. Ability to speak and write English with good writing skills, Spanish speaking/writing is a plus
Experience and Education
- Experience as a Quality assurance
- High school diploma or GED.
- 2-5 years of experience in Quality Assurance or Quality Control in food, dietary supplements, or cosmetic manufacturing.
- Experience with documentation review, COA verification, and GMP compliance.
- Experience working with NSF, SQF, Organic, Kosher, Halal certification requirements
Preferred
- Experience with Organic, Kosher, and/or NSF/455-2 certification programs.
- Experience with Environmental Monitoring Programs and internal audits.
- Knowledge of hazard analysis and risk assessment.
- Experience with CAPA, supplier approval, and customer complaint investigations.
- Bilingual English/Spanish is strongly preferred at Aspen Co-Pak.
- Associate’s or Bachelor’s degree in a science-related field (Food Science, Biology, Chemistry, etc.) a plus
Physical Requirements
- Ability to lift up to 30 lbs.
- Ability to stand, walk, and move between production, warehouse, and office areas.
- Ability to work in a manufacturing environment requiring PPE.