QC Senior Specialist, Quality Laboratory

QC Senior Specialist, Quality LaboratoryCamarillo, CATitle: QC Senior Specialist, Quality LaboratoryReports to: Director, Quality LaboratoryLocation: Camarillo, CAClassification: ExemptOverview: 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 oversee laboratory investigations, identify and implement CAPAs, and manage analytical method lifecycle activities including protocol drafting and execution of method validation, verification, and transfer in accordance with regulatory expectations.ResponsibilitiesPerform and review routine in-process, release, and stability testing for biologic drug substances and drug productsExecute and troubleshoot a range of analytical methods including HPLC/UPLC (SEC, RP, CEX, Peptide Mapping)Perform capillary electrophoresis testing (cIEF, CE-SDS)Perform plate-based ELISA, ligand binding assaysPerform compendial methods relevant to large molecule therapeutics (USP/EP/JP)Lead laboratory investigations, including OOS, OOT, and atypical result investigationsConduct root cause analysis and identify, implement, and verify effectiveness of CAPAsDraft and oversee protocols for method validation, verification, and transferInterpret results, perform statistical analyses, and prepare validation reports aligned to ICH Q2 and US FDA expectationsAuthor and review SOPs, test methods, protocols, and technical reportsEnsure all work is performed in compliance with cGMP, data integrity principles, and internal QA/QC policiesSupport regulatory inspections and audits as a subject matter expertMaintain departmental instruments and ensure timely execution of QC quality system recordsMentor team members and oversee analytical workflows to meet project goalsQualificationsBachelor's, Master's, or Ph.D. in Biology, Chemistry, Biochemistry, or a related scientific fieldMinimum of 10 years of direct, hands-on experience in a GMP Quality Control laboratory supporting biologicsDeep technical proficiency with HPLC, ELISA, capillary electrophoresis, and compendial testing preferredStrong background in laboratory investigations, OOS management, and CAPA implementationHands-on experience with method validation aligned to ICH Q2 and US FDA regulationsExcellent technical writing, documentation, and analytical troubleshooting skillsAbility to work independently while collaborating effectively across QC, QA, and ManufacturingExperience in a commercial-stage or late-phase biologics environment is preferredFamiliarity with LIMS and chromatography data systems (e.g., Chromeleon) is highly desirableStrong familiarity with GxPExcellent communication, interpersonal and organizational skills are requiredThe Base Salary Range for this position is $115,000 to $145,000. 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.J-18808-Ljbffr