Position Summary
We are seeking a Quality Assurance (QA) Specialist with dedicated experience to oversee the compliance, safety, and physical integrity of our dietary supplement lines. This role focuses heavily on shop-floor quality operations, Master Batch Record verification, and in-process controls specifically tailored to automated tablet compression presses and high-speed capsule filling machines.
Key Responsibilities
- In-Process Controls: Perform routine floor audits and verify in-process checks during manufacturing, including tablet hardness, thickness, friability, weight variation, and capsule fill weights.
- Equipment Verification: Review and approve machine setup, clearance protocols, and cleaning validation logs (swab/rinse testing) for tablet presses and capsule fillers to prevent cross-contamination.
- Batch Record Review: Audit executed batch records, encapsulation logs, and tablet compression run charts for accuracy, yield calculations, and compliance with 21 CFR Part 111.
- Deviation & OOS Investigation: Lead investigations into machine-related deviations, such as tablet capping/lamination, weight fluctuations, or capsule defects, and implement effective CAPA plans.
- SOP Maintenance: Draft and update Standard Operating Procedures (SOPs) for the operation, sanitation, and quality verification of solid-dose production equipment.
Qualifications & Technical Requirements
- Education: Bachelor’s degree in chemistry, Biology, Food Science, Chemical Engineering, or a related technical discipline.
- Industry Experience: Minimum 2–4 years of QA or high-level Quality Control experience inside a cGMP dietary supplement or pharmaceutical facility.
- Machinery Knowledge: Hands-on familiarity with the operational quality parameters of automated tablet compression tooling and semi-automatic or fully automatic capsule filling equipment.
- Regulatory Expertise: Strong working knowledge of FDA dietary supplement regulations (21 CFR Part 111).
Pay: $26.81 - $42.29 per hour
Work Location: In person
