Quality Control Laboratory Specialist

Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team.

Job Title: Quality Control Laboratory Specialist

Location(s): Tarzana, California

Client is seeking an energetic and experienced individual with method automation background to join our Quality Control (QC) team. The Automation Engineer / Analyst, QC Analytical will lead the effort of validating automated workflows for dPCR and Flow cytometry methods. This role will work within QC Analytical team and collaborate with IT, Analytical Sciences, and facility teams to validate the CAR percentage and Vector Copy Number methods for our late phase cell therapy product. The successful candidate will lead the team to transition from our manual assays into compliant, high-throughput automated processes within a regulated cGMP environment.

• Perform automated dPCR, flow cytometry, and other supporting procedures to validate the methods and enable the release testing and stability monitoring of cell therapy products and in-process samples.
• Support technical transfer from Analytical Development, receive analytical method training, pre-qualification tests, and validation executions.
• Act as a subject matter expert in technical discussion, document review, and investigations.
• Prepare departmental SOPs, technical documents, undertake investigations, and draft troubleshooting plans.
• Support quality events (change control, deviations, and CAPA), QC Operations, including LIMS implementation, equipment qualification, maintenance and calibration, and Sample Management.
• Perform other duties as requested by supervisor to support the implementation of automated methods.
• Author and/or review analytical test results, technical and regulatory documents including but not limited to analytical study data summaries and reports, analytical method validation protocols and reports, standard operating procedures (SOP).

• Hands-on experience with laboratory automation platforms and automated workflow integration of analytical methods in QC or AD environment.
• Experience supporting automated liquid handlers such as Hamilton, Duet, Tecan, or similar systems.
• Understanding of QC workflows and sample processing operations.
• Experience leading or supporting automation integration and cross-functional technical projects.
• Familiarity with quality systems such as Veeva and working knowledge of cGMP environments, quality events (change control, deviations and CAPA) and data integrity expectations.
• Strong communication, collaboration, and problem-solving skills.

Preferred Qualifications:

• Experience in Hamilton and/or other cGMP automatic liquid handling instruments for QC assays.
• Experience in various cell therapy analytical techniques including Flow cytometry, and dPCR.

Education and Experience

• B.S. in Immunology, Cell Biology, Bioengineering, Analytical Sciences, or a related scientific discipline with 2 years of relevant hands-on experience or
• M.S. in Immunology, Cell Biology, Bioengineering, Analytical Sciences, or a related scientific discipline with 1 year of prior industry experience required.

Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans or individuals with disabilities.