Scientist - QC Validation

Job Title:- Quality Control Validation Scientist
Location: Thousand Oaks CA
Duration: 6+ months
 
Job Description:
We are seeking a Quality Control Validation Scientist to support Quality Control activities within the Analytical Quality Control (AQC) department. This role will focus on analytical method transfer, validation, troubleshooting, documentation, and execution within a cGMP pharmaceutical/biopharmaceutical environment.
The ideal candidate will have hands-on experience with analytical method validation/transfer, laboratory investigations, technical documentation, and regulatory requirements.
 
Key Responsibilities
Drive analytical method validation and method transfer of laboratory methodologies, including raw material testing.
Execute and support test plans, protocols, discrepancies, investigations, and issue resolution.
Troubleshoot analytical methods and provide scientifically sound recommendations.
Ensure laboratory equipment remains in a validated state and that analytical methods comply with company and regulatory requirements.
Prepare and review validation protocols, reports, technical documents, and other laboratory documentation.
Support raw material qualification activities for new products.
Apply scientific principles and statistical techniques to analyze data, troubleshoot issues, and support decision-making.
Support installation, operational qualification (IOQ), maintenance, and troubleshooting of laboratory instrumentation.
Ensure project deliverables, timelines, and milestones are met.
Collaborate with Quality, QC, Manufacturing, Validation, and other cross-functional teams.
Perform other duties as assigned.
 
Required Qualifications
Bachelor's degree in Biotechnology, Microbiology, Pharmacy, Chemistry, or a related scientific field.
Minimum 1+ year of analytical development or validation experience within a pharmaceutical, biopharmaceutical, or related manufacturing environment. An advanced degree may be considered in lieu of experience.
Strong knowledge of analytical methods and method validation.
Understanding of cGMP laboratory practices and unexpected-result investigations.
Working knowledge of regulatory standards and requirements, including cGMP, QSR, USP, 21 CFR, and ICH.
Strong technical writing skills with the ability to prepare protocols, reports, and regulatory-compliant technical documentation.
Intermediate knowledge of statistics and data analysis.
Strong analytical, troubleshooting, and problem-solving skills.
Ability to work independently with minimal direction while managing multiple priorities.
Strong attention to detail, organization, and time-management skills.
Proficiency with Microsoft Office.
Ability to work effectively in a dynamic, cross-functional environment.
 
Nice-to-Have Skills
Experience with Kneat or other paperless validation platforms.
Experience reviewing and approving validation lifecycle documentation.
Experience with paperless validation software used within life sciences.
Knowledge of Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports.
Experience with equipment, facilities, and utilities qualification within a biopharmaceutical manufacturing facility.
Experience with Computer System Validation (CSV) protocols and reports, including SCADA and MES systems.
Experience with QC/Microbiology laboratory instrument qualification and analytical method validation.
 
Work Environment
Combination of office and laboratory environment.
May require work in controlled or cleanroom environments with specialized gowning.
May involve exposure to laboratory chemicals, including alcohols, acids, and buffers, with appropriate PPE/respiratory protection as required.
Must be able to work extended hours, including more than 8 hours per day or 40 hours per week, as business needs require.