Quality Control Technical Shift Lead - San Diego

Quality Control Technical Shift Lead

Location: San Diego, CA |

Employment Type:

Full-Time

Bring Scientific Expertise and Leadership to Daily QC Operations

At Poly Peptide, we partner with pharmaceutical and biotech companies to support the development and manufacturing of peptide-based therapies. We are looking for a Quality Control Technical Shift Lead to help lead daily QC laboratory operations, guide analysts, and ensure analytical testing is completed accurately, efficiently, and in compliance with GMP requirements.

This role is ideal for someone who brings strong scientific and technical knowledge, hands-on analytical testing experience, and the leadership skills needed to support a high-performing QC team. Whether you are a senior analyst ready to take the next step or an experienced technical lead looking for a broader leadership role, this position offers the opportunity to make a direct impact on product release, laboratory performance, and quality outcomes.

The Quality Control Technical Shift Lead is responsible for coordinating daily QC testing activities, prioritizing laboratory workload, monitoring sample turnaround times, and ensuring critical testing is completed to support manufacturing and product release timelines.

In this role, you will serve as a key technical resource for QC analysts. You will provide guidance on analytical testing, troubleshooting, investigations, data review, and laboratory best practices. You will also work closely with Quality Assurance, Manufacturing, and other cross-functional teams to support timely decision-making, compliance, and operational excellence.

This position requires someone who can balance scientific expertise with people leadership. The right candidate will be confident reviewing data, resolving technical issues, supporting analysts, and helping maintain a strong culture of quality, accountability, and data integrity.

• 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.
• 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.

• Bachelor's degree in chemistry, biochemistry, or a related life sciences field required.
• 4+ years of experience in a GMP-regulated Quality Control laboratory.
• At least 1 year of experience in a leadership, senior analyst, technical lead, or team lead capacity.
• Experience supporting laboratory workload planning, technical troubleshooting, investigations, data review, or analyst guidance preferred.
• Experience with peptide products is highly desirable.

• Hands-on experience with HPLC, GC, and other analytical instrumentation.
• Strong scientific understanding of analytical testing, laboratory methods, and quality control principles.
• Strong understanding of cGMP, ICH, USP, EP, SOPs, regulatory expectations, and data integrity requirements.
• Experience reviewing analytical data and supporting documentation accuracy.
• Ability to troubleshoot testing methods, instruments, investigations, and quality-related issues.
• Ability to interpret technical results and communicate findings clearly to internal teams.

• Ability to lead daily priorities and support…