WHAT YOU WILL DO:
- Provide oversight of Quality Assurance and Quality Control activities at the site level, including manufacturing, packaging, labeling, and holding operations.
- Approve or reject procedures, specifications, controls, test methods, validations, and results impacting product quality.
- Conduct internal audits, deviation investigations, root cause analysis, CAPAs, and OOS reviews.
- Serve as the site authority on compliance with FDA 21 CFR Part 111 and 18VAC110-60-10 et seq.
- Supervise document control processes and maintain GMP records as per regulatory standards.
- Review and approve Master Manufacturing Records (MMRs), Batch Production Records (BPRs), and Certificates of Analysis (COAs).
- Monitor calibration and preventive maintenance of laboratory and production equipment.
- Collaborate with cross-functional teams to ensure product quality from raw material receipt to product release.
- Maintain and manage sample retention programs and stability studies.
- Lead risk assessments and change control processes.
- Train and mentor QA team members; act as SME or system owner where applicable.
- Interface with regulatory bodies and lead readiness for inspections.
WHAT WE ARE LOOKING FOR:
- Bachelor’s degree in a technical field (e.g., Chemistry, Biology, Engineering)
- 2–5 years of Quality Assurance or Quality Control experience in a regulated manufacturing environment; experience in cannabis, pharmaceuticals, or dietary supplements preferred
- Demonstrated experience managing GMP compliance, quality systems, and regulatory audits
- Familiarity with FDA 21 CFR 111, ICH Q guidelines, and Virginia Board of Pharmacy regulations
- Experience with CAPA, deviation, and change management systems
- Strong leadership, communication, and problem-solving skills
- Ability to lift 50 lbs. and perform duties in both office and production environments
- Proficiency in Microsoft Office and electronic quality systems (EDMS, QMS software, etc.).