Quality Control Specialist

Meet Life Sciences; California; On-site; USD 110,000 - 170,000; Full time

Job summary

Meet Life Sciences Ltd. seeks a senior QC Specialist to lead analytical testing efforts in a regulated biopharmaceutical environment. You will guide method oversight, investigations, and CAPA activities, ensuring data integrity and regulatory compliance across QC operations.

The role emphasizes technical mentorship, collaboration with QA, and continuous improvement to support product release, stability, and in-process testing using HPLC, electrophoresis, and immunoassays.

Qualifications

• Bachelor's degree in Biology, Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, Biotechnology, or related life science discipline.
• Master's degree preferred.
• 5–8+ years in a cGMP-regulated biotech/pharma lab.
• Hands-on experience with analytical testing methods for biologics.
• Knowledge of ALCOA+ data integrity and GMP requirements.

Responsibilities

• Provide technical support for routine analytical testing in the QC laboratory.
• Lead and support investigations of OOS/OOT results and deviations.
• Review data and provide scientific interpretation for quality decisions.
• Mentor QC team members and ensure GMP compliance.
• Support CAPA development and effectiveness assessments.
• Maintain accurate electronic lab records per GDP/ALCOA+.

Skills

Technical leadership

Analytical testing

CAPA & investigations

GMP/data integrity

Communication & organization

Education

Bachelor's degree in Biology/related

Master's degree preferred

Tools

HPLC

Analytical instrumentation

Job description

Duration: 6 months, with potential for extension or conversion to a permanent position

Engagement: W-2 only; no C2C or third-party vendors.

The QC Specialist serves as a senior technical contributor within the Quality Control organization, supporting analytical testing activities in a regulated biopharmaceutical environment. This individual will provide technical guidance, support laboratory operations, and help ensure testing activities are conducted in accordance with applicable cGMP requirements and quality standards.

The position will contribute to analytical method oversight, laboratory investigations, quality system activities, and continuous improvement initiatives while providing technical support and guidance to QC team members.

Technical Leadership & Analytical Responsibilities

• Provide technical support and subject matter expertise for routine analytical testing activities within the QC laboratory.
• Support and troubleshoot analytical methods used for product release, stability, and in-process testing.
• Perform and review analytical testing using techniques such as HPLC, electrophoresis, immunoassays, and other applicable analytical methods.
• Lead and support laboratory investigations involving out-of-specification (OOS) and out-of-trend (OOT) results, deviations, and analytical discrepancies.
• Conduct root cause investigations and support the development, implementation, and effectiveness assessments of CAPAs.
• Review analytical data and provide scientific interpretation to support quality and compliance decisions.
• Support laboratory systems, instrumentation, and digital initiatives designed to improve operational efficiency and data integrity.
• Assist with method performance monitoring, troubleshooting, and continuous improvement activities.
• Provide technical guidance and mentorship to QC team members.
• Maintain accurate laboratory documentation and electronic records in accordance with GDP and ALCOA+ principles.
• Ensure laboratory activities are performed in compliance with applicable GMP requirements and regulatory guidelines.
• Support audit and inspection readiness activities as needed.

Qualifications

Education

• Bachelor's degree in Biology, Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, Biotechnology, or a related life science discipline required.
• Master's degree preferred.

Experience

• 5–8+ years of relevant experience within a cGMP-regulated biotechnology, pharmaceutical, or contract testing laboratory.
• Strong hands-on experience with analytical testing methodologies supporting biologics.
• Experience with routine release and stability testing.
• Demonstrated experience supporting or leading laboratory investigations, deviations, CAPAs, and quality system activities.
• Working knowledge of GMP regulations, data integrity requirements, and ALCOA+ principles.
• Experience with laboratory systems, analytical instrumentation, and continuous improvement initiatives.
• Strong technical problem-solving, communication, and organizational skills.