Sr. QC Associate

About the role

Fujifilm Biotechnologies California is hiring a Senior Associate Quality Control (Sr. Associate Quality Control) to support our One Cell Therapy Business located in Thousand Oaks, California.

Responsibilities

• Performs routine testing for in-process, intermediates, final product, and stability of clinical and/or commercial lots including cell-based methods (e.g., viable cell count, Immunophenotyping, cytotoxicity, proliferation) as well as compendial testing (pH, Osmolality, Endotoxin, appearance, on the floor visual inspection).
• May act as subject matter expert for analytical methods, troubleshooting, investigations and/or technical reports as assigned by management.
• May participate in the analytical method transfer and/or validation, as well as critical reagents qualifications.
• Draft, revise and review laboratory Standard Operating Procedures (SOPs), test methods and technical documents under guidance of management.
• Train/support and work closely with QC Associates to ensure transfer of knowledge, collaborative role modeling of professional constructive problem solving.
• Role models compliance and Good Documentation Practices (ALCOA++) ensuring a culture of quality and procedural adherence.
• Supports management during internal and external inspections and audits.
• May lead projects aiding in preparation for inspection.
• Supports nonconformance investigations, root cause analysis and implement solutions as assigned by management.
• Supports laboratory equipment validations, as needed and assigned by management.
• Participate and or lead projects under management leadership and ensure timely completion.
• Ensure laboratory and documentation compliance with applicable company requirements and global regulations.

Qualifications

• Bachelor's degree in a relevant field such as Biochemistry, Molecular Biology, Microbiology, or related discipline.
• Minimum of 5 years of experience in a quality control laboratory environment, preferably in a GMP regulated setting.
• Experience with cell-based assays and compendial testing methods.
• Strong understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
• Proficiency in Microsoft Office Suite, particularly Excel and Word.
• Ability to work independently and as part of a team.
• Excellent communication and interpersonal skills.

Skills

• Strong analytical and problem-solving skills.
• Knowledge of regulatory guidelines and standards (e.g., FDA, EMA).
• Experience with laboratory equipment and instrumentation (e.g., spectrophotometers, flow cytometers).
• Ability to work effectively in a fast-paced, dynamic environment.

Benefits

At Fujifilm Biotechnologies California, we offer a competitive salary, comprehensive benefits package, and a supportive work environment. We also provide opportunities for professional growth and development within our organization.

Pay

The salary range for this position is $80,000 - $120,000 annually, depending on experience and qualifications.

Schedule

The position is full-time and works a standard Monday through Friday schedule.

Benefits

• Health insurance (medical, dental, vision)
• 401(k) retirement plan with company match
• Flexible spending accounts for medical and dependent care expenses
• Employee assistance program
• Generous paid time off policy
• Professional development opportunities

Application Instructions

To apply for this position, please visit our careers page at https://www.fujifilm.com/us/en/about/region/careers.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBCHR@fujifilm.com).