Assistant QA Manager

Position Summary 

The Assistant Quality Assurance Manager supports the Quality Assurance Manager in leading all Quality Assurance functions within the CMDO dietary supplement manufacturing facility. This position is responsible for supervising QA personnel, overseeing Quality Control activities, maintaining compliance with FDA 21 CFR Part 111, cGMP, customer requirements, and the Company's Quality Management System (QMS). The Supervisor serves as the primary backup to the QA Manager and provides leadership to ensure product quality, regulatory compliance, and continuous improvement. 

Essential Duties and Responsibilities 

1. Quality Management System (QMS) 

• Maintain and continuously improve the Quality Management System (QMS). 

• Ensure compliance with FDA 21 CFR Part 111, cGMP, customer and company requirements. 

• Monitor quality KPIs and support Management Review. 

2. Document Control 

• Manage controlled documents including SOPs, Work Instructions, Specifications, Forms, MMRs, BPRs and Quality Records. 

• Control document revisions, approvals, distribution, retention and periodic review. 

3. Batch Record Review & Product Release 

• Review Batch Production Records (BPRs), COAs, deviations and release documentation. 

• Support final batch disposition and product release. 

4. Quality Assurance Operations 

• Supervise incoming, in-process and finished product inspections. 

• Verify packaging, labeling, line clearance and sample retention activities. 

5. Quality Control Oversight 

• Provide oversight of QC laboratory activities to ensure compliance with GMP and approved methods. 

• Review laboratory results, COAs, OOS/OOT investigations and laboratory deviations. 

• Coordinate raw material, in-process, finished product, microbiological, environmental monitoring and stability testing. 

• Ensure laboratory documentation follows Good Documentation Practices (GDP). 

• Support laboratory equipment qualification, calibration and preventive maintenance. 

• Participate in laboratory audits and continuous improvement. 

6. CAPA / Deviations / Nonconformance 

• Lead investigations, Root Cause Analysis, CAPA implementation and effectiveness verification. 

7. Customer Complaints 

• Investigate complaints, perform trend analysis and implement corrective actions. 

8. Audits & Regulatory Inspections 

• Lead internal audits and support FDA, customer and third-party audits. 

9. Supplier Quality 

• Support supplier qualification, SCAR management and supplier performance review. 

10. Change Control 

• Coordinate change control for materials, formulas, packaging, equipment, specifications and procedures. 

11. Training 

• Coordinate GMP, GDP, SOP and Quality System training and maintain training records. 

12. Validation & Calibration 

• Support process validation, cleaning validation, equipment qualification and calibration programs. 

13. Leadership & People Management 

• Supervise QA/QC personnel, assign work, coach employees, conduct performance evaluations, support hiring and act for the QA Manager when required. 

14. Continuous Improvement 

• Lead Lean and continuous improvement initiatives and perform other assigned duties. 

Qualifications 

• Bachelor's Degree in Food Science, Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Nutrition, Engineering or related scientific discipline. Master's Degree preferred. 

• Minimum 5 years of QA experience in dietary supplements, pharmaceuticals, food or other GMP-regulated manufacturing. 

• Minimum 2 years of supervisory experience preferred. 

• Strong knowledge of FDA 21 CFR Part 111, cGMP, HACCP, QMS, CAPA, Change Control, GDP and Root Cause Analysis. 

• Experience with ERP/MRP systems and Microsoft Office. 

• Excellent leadership, communication, analytical and problem-solving skills. 

Physical Requirements 

• Ability to sit, stand, walk and work in office and manufacturing environments. 

• Ability to occasionally lift up to 25 pounds. 

• Ability to wear required PPE in production areas. 

Key Performance Indicators (KPIs) 

• Batch Record Review Accuracy 

• Product Release Cycle Time 

• Document Control Accuracy 

• CAPA On-Time Closure 

• Deviation Closure Effectiveness 

• OOS/OOT Investigation Timeliness 

• Laboratory Compliance 

• Internal & External Audit Performance 

• FDA Inspection Readiness 

• Customer Complaint Resolution 

• Supplier Quality Performance 

• Training Completion Rate 

• Team Productivity 

• Continuous Improvement Achievement 

Salary - $75,000 - $95,000 DOE Generous PTO, Matching 401k, Medical, Dental, Vision, Pet, Life, and Disability Insurance