Quality Control Technical Shift Lead - San Diego

Quality Control Technical Shift Lead

Location: San Diego, CA |

Employment Type:

Full-Time

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 oversee daily laboratory testing operations, support QC analysts, and ensure testing is completed accurately, efficiently, and in compliance with GMP requirements.

This role is a strong fit for someone with hands‑on QC laboratory experience who is ready to take the next step in leadership, or someone who has already served as a senior analyst, lead, or technical resource within a GMP-regulated laboratory.

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

In this role, you will serve as a primary technical resource for QC analysts, support troubleshooting and laboratory investigations, review testing data, and collaborate closely with Quality Assurance, Manufacturing, and other cross‑functional teams. You will play an important role in maintaining laboratory compliance, supporting continuous improvement, and promoting 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.
• 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.

• 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, troubleshooting, investigations, or analyst guidance preferred.
• Experience with peptide products is highly desirable.

• Hands‑on experience with HPLC, GC, and other analytical instrumentation.
• Strong understanding of cGMP, ICH, USP, EP, and applicable regulatory guidelines.
• Experience reviewing analytical data and supporting documentation accuracy.
• Ability to troubleshoot testing methods, instruments, and quality issues.
• Strong understanding of quality control principles, data integrity, and laboratory compliance expectations.

• Technical proficiency in analytical testing.
• Strong cGMP compliance and documentation accuracy.
• Problem‑solving and quality issue resolution.
• Attention to detail and commitment to data integrity.
• Strong collaboration, communication, and interpersonal skills.
• Ability to lead daily priorities, support analysts, and foster accountability within the team.
• Solution‑oriented mindset with a focus on quality, efficiency, and operational excellence.