GMP QC Shift Lead — Lab Operations

PolyPeptide Group; San Diego (CA); On-site; USD 45,000 - 55,000; Full time

Job summary

PolyPeptide in San Diego, CA is seeking a Quality Control Technical Shift Lead to oversee daily QC testing, prioritize work, and support product release timelines. The role combines hands-on assay work with team leadership.

You will mentor QC analysts, investigate issues, ensure data integrity, and maintain GMP compliance with USP/ICH guidelines while collaborating with QA, Manufacturing and other groups to maintain quality and efficiency.

Qualifications

• Bachelor’s degree in chemistry, biochemistry, or a related life sciences field is required.
• 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.
• Support compliance with USP, EP, ICH, cGMP, SOPs, regulatory submissions, and data integrity standards.
• Serve as a technical resource for QC analysts and provide guidance on testing, troubleshooting, and laboratory practices.
• Execute complex testing and operate analytical instruments to support raw material, intermediate, in-process, and finished product testing.
• Prepare samples and solutions in accordance with established methods and protocols.
• Calibrate testing and measurement equipment to ensure accuracy and reliability.
• Review test result data and identify issues related to materials, products, methods, or equipment.
• Recommend solutions or corrective actions for quality issues.
• Support general “Go / No Go” processing decisions as appropriate.
• Maintain high laboratory organization and cleanliness standards, including 5S and Kanban practices.
• Approve time reporting documents and support daily team coordination.
• Perform additional duties as required.

Skills

Analytical testing

Quality mindset

Collaboration

Attention to detail

Problem‑solving

Education

Bachelor’s degree in chemistry or related life sciences

Tools

HPLC

GC

Job description

PolyPeptide in San Diego, CA is seeking a Quality Control Technical Shift Lead to oversee daily QC testing, prioritize work, and support product release timelines. The role combines hands-on assay work with team leadership.

You will mentor QC analysts, investigate issues, ensure data integrity, and maintain GMP compliance with USP/ICH guidelines while collaborating with QA, Manufacturing and other groups to maintain quality and efficiency.