QA/QC Specialist - Dietary Supplement Manufacturer (21 CFR 111 )

Qualifications

• 1+ year in a QA or QC role in dietary supplements or food/beverage.
• 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 Lean Manufacturing / Six Sigma
• 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.

Skills

• Improve how we work by standardizing templates and workflows (SOPs, forms, logs, batch packets) to reduce human error and rework.
• Strengthen specifications, acceptance criteria, and review workflows so release decisions are consistent and fast.
• Help establish 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/quarantine 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.

Responsibilities

• Partner with Quality leadership to identify compliance 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 human error and rework.
• Strengthen specifications, acceptance criteria, and review workflows so release decisions are consistent and fast.
• Help establish 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/quarantine 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.