Quality Assurance Manager

Job Type: Full-time, on-site

Compensation: $85,000–$95,000 base salary + up to 10% annual performance bonus

Schedule:

Day shift, beginning early enough to overlap with manufacturing operations. Exact hours will be discussed during the interview.

Reports To:

Executive Management

Salud Natural Entrepreneur, Inc. is seeking a hands‑on Quality Assurance Manager to lead daily Quality Assurance and Quality Control operations at our dietary supplement manufacturing facility in Waukegan, Illinois.

This highly visible, on‑site leadership role is directly responsible for batch review, material disposition, laboratory and testing oversight, deviations and CAPA, and finished‑product release under 21 CFR Part 111.

You will work closely with Production, Warehouse, third‑party laboratories, and Executive Management while maintaining independent authority over Quality decisions. We seek a practical Quality professional comfortable working on the manufacturing floor and reviewing documentation, investigations, specifications, and laboratory results.

• Lead daily QA/QC activities across manufacturing, packaging, labeling, and storage.
• Maintain regular presence on the manufacturing and packaging floor to identify and address Quality issues in real time.
• Review completed Batch Production Records and verify compliance with approved Master Manufacturing Records before final disposition.
• Review raw-material, in-process, and finished-product specifications, laboratory reports, Certificates of Analysis, and applicable testing results.
• Approve or reject incoming components and raw materials; maintain controls for quarantined, held, released, and rejected materials.
• Release or reject finished‑product batches as authorized by established procedures.
• Review deviations and Exception Events; conduct or coordinate investigations, root‑cause analysis, CAPAs, and effectiveness reviews.
• Evaluate out‑of‑specification (OOS), out‑of‑trend (OOT), and other questionable laboratory results.
• Participate in supplier qualification and requalification and coordinate with contract laboratories.
• Review and approve or reject reprocessing and repackaging activities.
• Ensure manufacturing documentation is complete, accurate, controlled, and recorded when activities occur.
• Support SOP review, document control, employee GMP training, audit readiness, and FDA inspection readiness.
• Collaborate with Production while maintaining independent authority over Quality decisions, including HOLD, rejection, and batch disposition.
• Escalate significant Quality or compliance concerns directly to Executive Management.

Within approved procedures, this position has authority to:

• Place components, raw materials, work‑in‑process, and finished products on HOLD.
• Reject materials that do not meet applicable specifications and prevent use of unreleased materials.
• Require investigation of discrepancies, deviations, OOS/OOT results, and deficient batch documentation.
• Approve or reject reprocessing, repackaging, and finished‑product batches as authorized.
• Stop affected operations when continuation could compromise product quality, documentation integrity, or compliance.
• Escalate significant Quality concerns directly to Executive Management.

Production schedules, customer urgency, and commercial considerations do not supersede applicable Quality requirements.

• 3+ years of Quality experience in an FDA‑regulated manufacturing environment; direct dietary supplement or nutraceutical experience strongly preferred.
• Direct working knowledge of 21 CFR Part 111.
• Hands‑on experience reviewing Batch Production Records.
• Experience with raw‑material approval or rejection and…