Quality Control Manager

Job Description

Job Description

Benefits/Perks

• Competitive Compensation
• Great Work Environment

Job Summary

Agile Nutra, a co-manufacturer of sports nutrition located in Horsham, is seeking a detail-oriented, dependable, and hands-on Quality Control Specialist to support daily quality activities within its manufacturing operations. This in-house full time position is responsible for performing tasks related to microbiology testing, and ensuring compliance with product specifications, Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (cGMPs), and company quality standards.  Demonstrated experience reviewing, interpreting, and making quality decisions based on microbiological testing data in a GMP-regulated manufacturing environment

Responsibilities 

• Microbiology & Laboratory Testing
• GMP & Regulatory Compliance
• Audit current processes to improve efficiency
• Producing and managing COA documentation that accompanies each manufacturing job.

Qualifications

• Minimum 5–10 years of Quality Assurance experience in dietary supplements, nutraceuticals, food, or pharmaceutical manufacturing.
• Minimum 3 years of management or supervisory experience.
• Hands-on experience reviewing and interpreting microbiological testing results.
• Experience managing microbiology programs for raw materials, finished products, environmental monitoring, and water systems.
• Experience investigating microbiological deviations, contamination events, and OOS results.
• Experience working with third-party analytical and microbiological laboratories.
• Demonstrated experience leading a team desired
• Demonstrated experience in Quality Control or Quality Assurance desired
• Strong attention to detail
• Excellent communication and interpersonal skills

Technical Knowledge

• Strong understanding of:
  • FDA cGMP regulations
  • FDA 21 CFR Part 111 (Dietary Supplements)
  • FDA 21 CFR Part 117 (Food Manufacturing)
  • NSF/ANSI 455
  • HACCP
  • SQF/BRC
  • CAPA systems
  • Supplier qualification programs
  • Root cause analysis methodologies
  • Microbiology Technical Knowledge:
    • Strong understanding of microbiological testing methodologies including:
      • Total Aerobic Microbial Count (TAMC)
      • Total Yeast & Mold Count (TYMC)
      • Coliforms
      • E. coli
      • Salmonella
      • Staphylococcus aureus
      • Pseudomonas aeruginosa
      • Enterobacteriaceae
    • Knowledge of:
      • USP <61> , <62> , and <2021>
      • FDA cGMP requirements
      • Environmental monitoring programs
      • Water quality and microbiological control systems

Performance Metrics

• Audit outcomes and closure rates
• Customer complaint trends
• CAPA completion effectiveness
• Right-first-time batch release percentage
• Supplier qualification compliance
• Regulatory inspection results
• On-time product release performance
• GMP training completion rates