QC Analyst, Quality Control Laboratory

Coherusbiosciences; Camarillo (CA); On-site; USD 90,000 - 110,000; Full time

Job summary

Coherus Biosciences, located in Camarillo, CA, is seeking a QC Analyst in the Quality Control Laboratory. This pivotal role demands expertise in HPLC and ELISA, and offers the opportunity to lead complex testing and laboratory investigations.

The ideal candidate possesses a Bachelor's or Master's degree in a related scientific field and at least 3 years of QC experience. The salary range for this position is $90,000 to $110,000 annually, reflecting professional background and experience.

Coherus values diversity and provides equal opportunity to all applicants.

Qualifications

• Minimum of 3 years of hands‑on QC experience in a GMP Quality Control laboratory.
• Experience with method validation aligned to ICH Q2 and US FDA regulations.
• Ability to work independently while collaborating effectively across QC, QA, and Regulatory.

Responsibilities

• Perform and review routine in-process, release, and stability testing.
• Conduct root cause analysis and implement CAPAs.
• Mentor team members and oversee analytical workflows.

Skills

Technical proficiency with HPLC

ELISA experience

Capillary electrophoresis

Analytical troubleshooting

Excellent communication skills

Education

Bachelor's or Master's in Biology, Chemistry, or Biochemistry

Tools

LIMS

Chromatography data systems (e.g., Chromeleon)

Job description

Title: QC Analyst, Quality Control Laboratory

Reports to: Director, Quality Laboratory

Location: Camarillo, CA

Classification: Exempt

Overview

This laboratory position will be in the Quality Control Department and support activities associated with routine in-process testing, Certificate of Analysis (COA) release testing, and stability program support for biologics. This position will demonstrate strong technical proficiency with analytical methods, operate as a technical leader within the QC team, supporting complex testing, driving investigation quality, and ensuring compliant execution of analytical programs.

In addition, this position will support laboratory investigations, identify and help implement CAPAs, and participate in analytical method lifecycle activities including protocol drafting and execution of method validation, verification, and transfer in accordance with regulatory expectations.

Responsibilities

• Perform and review routine in-process, release, and stability testing for biologic drug substances and drug products while adhering to GMP/GDP QC requirements
• Experience performing plate-based ELISA, ligand binding assays required
• Execute and troubleshoot a range of analytical methods including HPLC/UPLC (SEC, RP, CEX, Peptide Mapping), capillary electrophoresis testing (cIEF, CE-SDS)
• Perform compendial methods relevant to large molecule therapeutics (USP/EP/JP)
• Support laboratory investigations, including OOS, OOT, and atypical result investigations
• Conduct root cause analysis and identify, implement, and verify effectiveness of CAPAs
• Draft and oversee protocols for method validation, verification, and transfer
• Interpret results, perform statistical analyses, and prepare validation reports aligned to ICH Q2 and US FDA expectations
• Author and review SOPs, test methods, protocols, and technical reports
• Ensure all work is performed in compliance with cGMP, data integrity principles, and internal QA/QC policies
• Support regulatory inspections and audits as a subject matter expert
• Maintain departmental instruments and ensure timely execution of QC quality system records
• Mentor team members and oversee analytical workflows to meet project goals

Qualifications

• Bachelor’s or Master’s in Biology, Chemistry, Biochemistry, or a related scientific field.
• Minimum of 3 years of direct, hands‑on QC experience in a GMP Quality Control laboratory supporting biologics.
• Technical proficiency with HPLC, ELISA, capillary electrophoresis, and compendial testing.
• Background in laboratory investigations, OOS management, and CAPA implementation.
• Hands‑on QC experience with method validation aligned to ICH Q2 and US FDA regulations.
• Excellent technical writing, documentation, and analytical troubleshooting skills.
• Ability to work independently while collaborating effectively across QC, QA, and Regulatory.
• Experience in a commercial‑stage or late‑phase biologics environment is preferred.
• Familiarity with LIMS and chromatography data systems (e.g., Chromeleon) is highly desirable.
• Strong familiarity with GxP requirements.
• Excellent communication, interpersonal and organizational skills are required.

The Base Salary Range for this position is $90,000 to $110,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.

Coherus provides equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We also prohibit discrimination based on the perception that anyone has any of these characteristics or is associated with a person who has or is perceived as having any of these characteristics.