QC Analyst, Quality Control Laboratory

About the role

This position operates as a full-time role based in Camarillo, California, where you will manage complex testing activities and decisions related to biologics stability and release. You will drive compliant investigations and lead continuous method improvements within a highly regulated environment, ensuring strict adherence to current Good Manufacturing Practice standards. The reported compensation range is clearly defined as $90,000 to $110,000 annually, subject to individual qualifications and experience. In this capacity, you will serve as a critical steward of product quality, owning the execution of release testing for biological drug substances and products. Your work will directly support the company's commitment to delivering safe and effective therapies to patients by maintaining the highest standards of data integrity. You will mentor team members and coordinate closely with QA, Quality Control, and Regulatory teams during inspections and audits to ensure seamless compliance.

Key facts

What you'll do

• Execute in-process, release, and stability testing for biologics in strict compliance with GMP and GDP standards.
• Perform and review a wide array of analytical tests, including but not limited to ELISA, ligand binding assays, HPLC, and capillary electrophoresis, to ensure product quality and regulatory readiness.
• Champion method troubleshooting and lifecycle management for a diverse portfolio of analytical techniques, ensuring robustness and reliability.
• Draft protocols and oversee activities related to method validation, verification, and transfer, aligning all work with ICH Q2 guidelines and US FDA expectations.
• Lead laboratory investigations concerning Out-of-Specification (OOS), Out-of-Trend (OOT), and atypical results to identify root causes and implement effective Corrective and Preventive Actions (CAPA).
• Review complex data sets, perform rigorous statistical checks, and author comprehensive validation reports to ensure accuracy, completeness, and regulatory compliance.
• Oversee the maintenance of critical laboratory instruments and associated data systems, such as Chromeleon, to guarantee optimal performance and data integrity.
• Ensure the timely completion of QC quality system records and documentation, maintaining meticulous organization and traceability for audit purposes.
• Mentor and guide team members, fostering a collaborative environment while coordinating closely with QA, Quality Control, and Regulatory teams during inspections and audits.
• Provide critical support for Certificate of Analysis release testing and stability program activities for both biologics drug substances and products, ensuring strict adherence to cGMP requirements.
• Drive method verification and transfer activities, documenting all results meticulously to meet stringent regulatory and project needs.
• Act as a subject matter expert in stability studies, applying advanced knowledge to support product lifecycle management and regulatory filings.

Requirements

Candidates must hold a Bachelor's or Master's degree in Biology, Chemistry, Biochemistry, or a related scientific field. A minimum of three years of hands-on QC experience in a GMP laboratory supporting biologics is essential for this role. You must demonstrate technical proficiency with ELISA, ligand binding assays, HPLC, capillary electrophoresis, and compendial testing to ensure accurate and reliable results. A background in laboratory investigations, OOS management, and CAPA implementation is required to effectively address complex quality issues. Hands-on experience with method validation according to ICH Q2 and US FDA regulations is mandatory to maintain compliance and ensure scientific rigor. Strong technical writing, analytical troubleshooting, and documentation skills are required to produce clear and precise records. The ability to work independently while effectively collaborating across QC, QA, and Regulatory functions is critical for seamless operations. Experience in a commercial-stage or late-phase biologics environment is preferred to ensure a deep understanding of the development landscape. Familiarity with Laboratory Information Management Systems (LIMS) and chromatography data systems is highly desirable, along with a strong understanding of GxP requirements and excellent interpersonal skills to facilitate cross-functional teamwork.

Nice to have

Experience with stability studies and method transfer in late-stage biologics programs is a distinct advantage that can enhance your contributions to the team.

Practical notes

This role is based in Camarillo, California, and operates as a full-time position. Please confirm specific details on the official application page regarding remote work policies, exact compensation breakdowns, and precise start dates. The job listing names Camarillo, CA. Applicants are encouraged to review the official application page for the most current information regarding responsibilities, compensation structure, and logistical details. The stability of the position and long-term growth opportunities may be discussed during the interview process. Ensure you meet the eligibility criteria before proceeding with your application to streamline the recruitment process.