QA​/QC Specialist - Dietary Supplement Manufacturer; CFR

Job Description

We are a fast-growing dietary supplement manufacturer operating in compliance with 21 CFR Part 111, seeking a hands-on QA/QC professional who is motivated by building, strengthening, and refining quality systems—not simply maintaining the status quo.

This role combines daily QA/QC execution (including raw materials & product receiving, in-process and final reviews for materials / documentation, material quarnatines and releases, and document control) with active Quality Management System development. Responsibilities include writing and reviewing SOPs, MMRs, and BPRs; supporting supplier qualification; strengthening CAPA effectiveness; and contributing to GMP training programs. You will partner closely with Quality leadership to enhance process consistency, reduce errors, and elevate our long-term “inspection-ready” posture.

The ideal candidate is comfortable operating in a dynamic, growing environment and is eager to help establish structure, drive continuous improvement, and ensure those improvements are sustainable.

• 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.

• 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.