Quality Control Analyst I​/III

Quality Control Analyst I / III

Pharmaceutical / Biopharmaceutical Manufacturing | 6-month Contract

A leading contract development and manufacturing organization (CDMO) is seeking Quality Control Analysts at two levels to support cGMP laboratory operations. These roles are integral to ensuring product quality, data integrity, and regulatory compliance across in-process, finished product, and stability testing programs. Both levels operate within a structured QC laboratory environment and contribute to cross‑functional initiatives involving Quality Assurance, Manufacturing, Microbiology, and external testing partners.

Candidate level placement will be determined based on relevant experience and technical skillset.

Location:

On‑site in Santa Rosa, CA

Employment Type:

6‑month contract with potential for extension or conversion

Hours:

M‑F 8‑5

• QC Analyst I: $27.40 - $41.35/hr
• QC Analyst II: $39.90 - $60.10/hr

• 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.
• Assist with laboratory investigations including out‑of‑specification (OOS) results, deviations, invalid assays, and other quality system activities.
• 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.

The QC Analyst I functions in a support capacity within the laboratory, performing routine and standardized testing activities under closer direction. This role is well‑suited for candidates early in their analytical career who are building foundational GMP laboratory skills.

• 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.
• Assist with day‑to‑day laboratory support activities as directed by senior laboratory personnel.

The QC Analyst III operates at a higher level of independence and technical complexity, taking on expanded responsibilities in method execution, investigation leadership, and cross‑functional collaboration. This role is suited for candidates with prior cGMP analytical experience seeking to broaden their scope.

• 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.
• Coordinate 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…