QC Instrument Qualification Lead — Analytical Scientist II

Apolis; Thousand Oaks (CA); On-site; USD 85,000 - 110,000; Full time

Job summary

Apolis in Thousand Oaks, CA is seeking a Quality Control Analytical Scientist II to join the Analytical Quality Control (AQC) team on a long-term on-site contract. The role centers on instrument qualification and ensuring instruments remain validated.

You will execute and transfer analytical methods in a cGMP environment, lead IOQ activities, support instrument installation, and contribute to method development and validation.

Qualifications

• Bachelor’s degree in Chemistry, Biotechnology, Microbiology, Pharmacy, or a related field.
• 3+ years of analytical development or validation experience in a GMP pharmaceutical, biopharmaceutical, or related manufacturing environment.
• Strong analytical instrument qualification experience is highly important.
• Experience with cGMP, USP, 21 CFR, ICH, QSR, and related regulatory requirements.
• Experience supporting OOS/OOT investigations, deviations, CAPAs, and laboratory investigations.
• Strong technical writing, analytical problem-solving, statistical/data analysis, organization, and project management skills.

Responsibilities

• Execute and transfer analytical methods in a cGMP environment.
• Lead/support installation, qualification (IOQ), maintenance, and troubleshooting of analytical instruments.
• Support new instrument implementation, installation, and qualification.
• Lead/support analytical method development and validation.
• Support investigations related to OOS, OOT, atypical results, deviations, and CAPAs.
• Review and approve laboratory investigations, protocols, reports, and technical documentation.
• Ensure laboratory equipment remains in a validated and compliant state.
• Support raw material qualification and new product testing.
• Analyze QC data using statistical tools to identify trends.
• Participate in cross-functional project teams and ensure timelines and milestones are met.
• Work with internal teams, global/local functions, and vendors.
• Lead small teams and special AQC projects as needed.

Skills

Analytical instrument qualification

Technical writing

Statistical/data analysis

Project management

Laboratory investigations

Education

Bachelor’s degree in Chemistry, Biotechnology, Microbiology, Pharmacy, or related field

Job description

Apolis in Thousand Oaks, CA is seeking a Quality Control Analytical Scientist II to join the Analytical Quality Control (AQC) team on a long-term on-site contract. The role centers on instrument qualification and ensuring instruments remain validated.

You will execute and transfer analytical methods in a cGMP environment, lead IOQ activities, support instrument installation, and contribute to method development and validation.