Quality Control Analyst II/III, Analytical

Role Summary

Quality Control Analyst II/III- Analytical. This onsite role is based in the Germantown, MD facility and provides Quality Control testing of clinical products, in-process and final product testing, and qualification of QC instrumentation.

Responsibilities

• Perform GMP release and stability testing in Quality Control including but not limited to: Cell-based potency assays, PCR/RT-qPCR, ELISA, Spectrophotometry, and Dynamic Light Scatter for biological samples.
• Perform HPLC for biological samples and troubleshoot Agilent HPLC equipment and Empower software.
• Train junior Analysts on test methods.
• Participate in technology transfer and validation activities including protocol and report writing.
• Complete documentation, including testing records and equipment logs, following Good Documentation Practices.
• Write, revise and review QC SOPs.
• Conduct peer review of test data and equipment logs.
• Maintain and operate QC laboratory equipment in a cGMP-compliant manner.
• Order, receive and manage inventory for QC materials.
• Apply critical thought to solving problems of complex scope.
• Prepare investigation reports, including those related to OOS, invalid assays and deviations.

Qualifications

• Bachelor‚Äôs Degree in biological science or related field.
• Minimum of five (5) years‚Äô experience working in a regulated QC laboratory for biological test samples, with demonstrated responsibility progression.
• Experience with analytical methods specific to gene therapy products including (but not limited to) PCR/RT-qPCR, ELISA, Spectrophotometry, Dynamic Light Scatter and HPLC.
• Demonstrated experience in the development of SOPs.
• Knowledge in principles and practices of current Good Manufacturing Practices (cGMPs).
• Experience with methods and systems used in a biological QC laboratory.

Skills

• Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.
• Self-organizer, meticulous hands-on habits, keen attention to detail.
• Ability to manage multiple and varied tasks, and prioritize workload.
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
• Proficient in MS-Word and MS-Excel.
• Strong quantitative and analytical skills.
• Ability to understand and execute on the company‚Äôs mission and values.
• Maintain a high degree of ethical standard and trustworthiness.
• Deals with conflict in a direct, positive manner.
• Ability to think and adapt to a rapidly changing environment and demands.
• Proficiency in aseptic technique, cell culture and the use of automated cell counting.
• Experience with cell culture required.

Education

• Bachelor‚Äôs Degree in biological science or related field.