We’re a fast-growing dietary supplement manufacturer operating under 21 CFR 111 , and we’re looking for a hands-on QA/QC professional who enjoys building and improving systems —not just maintaining what already exists. This role blends day-to-day QA/QC execution (receiving/in-process/final review, holds/releases, documentation) with quality system development (SOP/MMR/BPR improvements, supplier qualification, CAPA discipline, and training). You’ll work closely with Quality leadership to tighten processes, reduce errors, and raise the “inspection-ready” standard over time. You won’t be expected to own everything on day one—but you should be comfortable stepping into a growing environment where we’re actively getting better and need someone who can help create structure and make it stick. What you’ll do 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. Documentation & Record Control 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). Quality Control Operations 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). Supplier & Material Qualification Maintain the Approved Supplier List ; collect/assess questionnaires, audits, and performance data. Deviations, Investigations & CAPA Log and investigate deviations/OOS/OOT and drive CAPA through effectiveness checks. Track trends and propose preventive actions to reduce repeats.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed