Quality Control 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

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.