QA/QC Specialist
Quality System Continuous Improvement Partner with Quality leadership to identify gaps , prioritize improvements, and execute a practical roadmap across documentation, training, supplier qualification, and CAPA.
- Improve how we work by standardizing templates and workflows (SOPs, forms, logs, batch packets) to reduce mistakes and rework.
- Strengthen specifications, acceptance criteria, and review workflows so release decisions are consistent and fast.
- Help establish simple quality metrics (doc errors, deviations, supplier performance, training completion) and drive corrective/preventive actions.
- Draft, revise, and version-control SOPs, Work Instructions, forms, and logbooks ; route for review/approval; train teams on changes.
- Build and maintain Master Manufacturing Records (MMRs) (21 CFR 111.210) and ensure executed Batch Production Records (BPRs) (111.260) are complete, legible, and compliant.
- Support document change control (redlines, impact assessments, training, effective dates).
- Perform/coordinate receiving inspections , in-process checks, line clearance, label reconciliation, and finished product release/hold per specifications.
- Support sampling plans (ANSI/ASQ Z1.4 / ISO 2859), retain management, and reserve samples (111.83).
- Maintain the Approved Supplier List ; collect/assess questionnaires, audits, and performance data.
- Log and investigate deviations/OOS/OOT and drive CAPA through effectiveness checks.
- Track trends and propose preventive actions to reduce repeats.
Minimum (one of the following)
- 1+ year in a QA or QC role in dietary supplements, food/beverage, pharma, or cosmetics OR
- Relevant education/training (degree in relevant field, GMP certifications, etc.) demonstrating readiness to perform regulated QA/QC work.
- Experience supporting regulatory inspections or GMP certification audits.
- Experience with cloud-based ERP/MRP platforms .
- Experience developing/reviewing product specifications .
- Experience developing/reviewing product packaging and labeling .
- Solid Excel/Google Sheets skills (filters, pivot tables, lookups) and comfort learning digital tools (we use digital systems and expect you to learn quickly).
- Stand/walk on a production floor; lift up to 50 lbs occasionally; wear PPE; work around food-grade solvents and flavors.
- Adhere to hygiene, gowning, allergen, and sanitation rules.
- Must have reliable transportation; role may include traveling between sites.
- Must be willing to work early/later than business hours on occasion.
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