QA​/QC Specialist

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.

Requirements 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.

What You'll Bring Minimum (one of the following)

• 1+ year in a QA or QC role in dietary supplements, food/beverage, pharma, or cosmetics OR
• 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 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.

Benefits

• Health & Dental Insurance
• Paid Time Off
• Bonus Structure

#J-18808-Ljbffr