GMP QC Shift Lead: Lab Leadership & Analysis

PolyPeptide US

San Diego (CA)

On-site

USD 45,000 - 55,000

Full time

3 days ago
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Job summary

PolyPeptide in San Diego, CA is seeking a Science-driven QC Technical Shift Lead to guide daily QC laboratory operations and mentor analysts. The role emphasizes compliance with GMP, robust data integrity, and strong collaboration with QA, Manufacturing, and cross‑functional teams to ensure timely product release.

The candidate should bring hands-on testing experience with HPLC/GC, plus 4+ years in GMP QC and at least 1 year in a leadership capacity.

Qualifications

  • Bachelor’s degree in chemistry, biochemistry, or a related life sciences field.
  • 4+ years of experience in a GMP-regulated Quality Control laboratory.
  • At least 1 year of experience in a leadership, senior analyst, or team lead capacity.
  • Experience with peptide products is highly desirable.

Responsibilities

  • Coordinate daily QC testing activities, scheduling, planning, and project priorities.
  • Assign workload to analysts based on staffing levels, testing needs, and business priorities.
  • Monitor sample turnaround times and testing schedules to support timely material and product release.
  • Provide input on capacity constraints that may impact schedule adherence.
  • Serve as a technical resource for QC analysts and provide guidance on testing, troubleshooting, and laboratory practices.
  • Execute complex analytical testing and operate laboratory instruments to support raw material, intermediate, in-process, and finished product testing.
  • Support compliance with USP, EP, ICH, cGMP, SOPs, regulatory submissions, and data integrity standards.
  • Prepare samples and solutions in accordance with established methods and protocols.
  • Calibrate testing and measurement equipment to ensure accuracy and reliability.
  • Review analytical test data and identify issues related to materials, products, methods, documentation, or equipment.
  • Recommend solutions, corrections, or escalation paths for quality issues.
  • Support laboratory investigations, deviations, troubleshooting, and corrective actions.

Skills

Analytical testing
Leadership
Data review
Quality systems

Education

Bachelor’s degree in chemistry/biochemistry or related life sciences

Tools

HPLC
GC

Job description

PolyPeptide in San Diego, CA is seeking a Science-driven QC Technical Shift Lead to guide daily QC laboratory operations and mentor analysts. The role emphasizes compliance with GMP, robust data integrity, and strong collaboration with QA, Manufacturing, and cross‑functional teams to ensure timely product release.

The candidate should bring hands-on testing experience with HPLC/GC, plus 4+ years in GMP QC and at least 1 year in a leadership capacity.

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