Quality Control Technical Shift Lead - San Diego Quality Control · San Diego

PolyPeptide US; San Diego (CA); Presencial; USD 45 000 - 55 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Analytical testing

Leadership

Data review

Quality systems

Formação académica

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

Ferramentas

HPLC

GC

Descrição da oferta de emprego

Quality Control Technical Shift Lead

Location: San Diego, CA | Employment Type: Full-Time

Bring Scientific Expertise and Leadership to Daily QC Operations

At PolyPeptide, 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.

About the Role

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.

What You Will Do

• 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.

What We Are Looking For

Education and Experience

• 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.

Technical Skills

• 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.

Leadership and Competencies

• Ability to lead daily priorities and support analysts in a fast‑paced GMP laboratory environment.




• Strong technical judgment and confidence serving as a laboratory subject matter resource.




• Strong communication, collaboration, and interpersonal skills.




• Ability to coach, guide, and support team members while promoting accountability and quality.




• Strong problem‑solving skills and ability to resolve technical and operational challenges.




• High attention to detail and commitment to documentation accuracy and data integrity.




• Solution‑oriented mindset with a focus on quality, efficiency, and continuous improvement.

Why Join PolyPeptide?

This is an opportunity to step into a visible technical leadership role within a GMP Quality Control laboratory. You will help guide daily testing operations, support analyst development, troubleshoot technical challenges, and contribute directly to manufacturing and product release timelines.

As a QC Technical Shift Lead, your work will help ensure that materials and products are tested accurately, released on time, and held to high quality standards. This role is a strong fit for someone who enjoys combining scientific expertise, hands‑on laboratory work, team coordination, and cross‑functional problem solving.

Join PolyPeptide and help support high‑quality testing, timely product release, and operational excellence within our Quality Control team.

Salary: $33/hr - $40/hr

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.