Quality Control Analyst I/III

Position Details

Location: On-site in Santa Rosa, CA
Employment Type: 6-month contract with potential for extension or conversion
Hours: M-F 8-5

Compensation

Level Pay Range QC Analyst I $27.40 - $41.35/hr QC Analyst II $39.90 - $60.10/hr

Core Responsibilities (All Levels)

• Support QC laboratory testing using standard analytical techniques including pH, Osmolality, and FT-IR instrumentation for in-process, finished product, and stability sample analysis.
• Perform accurate documentation and data recording in accordance with cGMP principles, ALCOA+ standards, and data integrity requirements.
• Absorb and assist with laboratory investigations including out-of-specification (OOS) results, deviations, invalid assays, and other quality system activities.
• Absorb and assist with sample management activities including sample login, labeling, tracking, storage, and shipment coordination.
• Support stability program execution including sample pulls, submissions, inventory management, and tracking activities.
• Follow approved SOPs, test methods, and GMP laboratory procedures with appropriate supervision.
• Perform self-review of data and documentation for accuracy and completeness prior to submission for secondary review.

Level-Specific Responsibilities

QC Analyst I

• Execute routine laboratory testing using established methods and SOPs with minimal supervision.
• Perform data entry into relevant data management systems with accuracy and attention to detail.
• Absorb and assist with day-to-day laboratory support activities as directed by senior laboratory personnel.

QC Analyst III

• Perform complex analytical testing including HPLC, ELISA, and other advanced techniques with independent data evaluation.
• Troubleshoot equipment issues promptly and communicate resolutions to management.
• Evaluate data for trends and compile data summaries for management review and reporting.
• Support and/or lead investigations of OOS events through thorough root cause analysis, assessment of potential product impact, and implementation of appropriate corrective and preventive actions (CAPAs).
• Interact with cross-functional departments including attendance at meetings and provision of testing updates.
• Care for testing performed at outside testing laboratories including raw materials and external analytical services.
• Execute, author, and review SOPs, protocols, reports, investigations, change controls, and data summaries.
• Write and revise test methods and standard operating procedures in alignment with regulatory expectations.
• Provide training to junior laboratory personnel; attend internal and external training on relevant techniques and procedures, including intra- and inter-departmental cross-training.
• Enter, track, and trend data within relevant data management systems; present data summaries to management.
• Lead the stability program including management of test points, reporting of data, and investigation of out-of-specification or aberrant stability results.

Qualifications

QC Analyst I

• Bachelor's degree in Chemistry, Biology, Biochemistry, or a related life science discipline
• 0 to 2 years of relevant laboratory experience; prior cGMP exposure is a plus
• Familiarity with basic analytical instrumentation (e.g., pH meter, Osmometer, FT-IR)
• Working knowledge of GMP documentation practices and data integrity principles
• Strong attention to detail and ability to maintain accurate records
• Ability to follow written procedures and verbal instructions in a structured laboratory environment

QC Analyst II

• Bachelor's degree in Chemistry, Biology, Biochemistry, or a related life science discipline; advanced degree a plus
• Minimum 2 to 4 years of relevant QC laboratory experience in a cGMP-regulated pharmaceutical or biopharmaceutical environment
• Hands-on experience with complex analytical techniques including HPLC and/or ELISA
• Demonstrated ability to independently plan, execute, and evaluate laboratory investigations and OOS events
• Experience authoring or reviewing GMP documents including SOPs, protocols, reports, and change controls
• Experience with data management systems and trending/tracking activities preferred