Quality Control Analytical Scientist II

Job Title: Quality Control Analytical Scientist II
Location - Thousand Oaks, CA
100% Onsite
Long term contract
 
We are currently hiring for a Quality Control Analytical Scientist II to join the Analytical Quality Control (AQC) team in Thousand Oaks, CA.
Important Note from the Hiring Manager
The primary focus for this position is strong experience with analytical instrument qualification.
The hiring manager is specifically looking for candidates with a strong background in analytical instrument qualification, including installation, operational qualification (IOQ), troubleshooting, maintenance, and ensuring instruments remain in a validated state.
 
Key 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.

Required 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.

• Knowledge of analytical method validation and critical reagent qualification.

• 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.