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

Job Description

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.

  What you’ll do

Quality System Continuous Improvement

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.

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/ quarantine 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.

What you’ll bring
Minimum (one of the following)

• 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.

Bonus points if you have

• 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).

Physical & work environment

• 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.

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