QC Analyst 3

QC Analyst IV

The QC Analyst IV position will act as a team member of the Quality Control department to support the production of in-process and final product drug lots for customers. Also participate in quality testing for ongoing customer stability studies while providing on-time, high quality results to meet manufacturing demands.

A QC Analyst IV: Applies job skills and company's policies and procedures to complete a variety of tasks of increased scope. May be assigned to work on special projects. Also may provide support to others in the absence of the supervisor/manager. Works on problems of moderate scope in which analysis of situation or data requires review of identifiable factors.

Responsibilities:

• Provides feedback to junior analysts. Offers guidance to co-workers with respect to compliance.
• Delegates tasks to support daily operations.
• Responsible for the state of equipment in the laboratory, working with maintenance, calibration, and vendors to ensure their activities are accomplished and the equipment is ready for next use.
• Equipment may include but is not limited to, pH/conductivity meters, Agilent and Waters HPLC systems, UPLC systems, pipettes, SoloVPE and Cary 60 spectrophotometers, PA-800 capillary electrophoresis instruments, Protein Simple iCE3/icIEF instruments, 7500 Real Time PCR systems, KingFisher Flex instruments, Sysmex CS-2500 instruments and include quality review of quality and vendor binders.
• Troubleshoot equipment and software as necessary.
• Will train for assay execution and review within the HPLC Analytical Lab and Electrophoresis lab and have ability to cross train into Immunology as applicable.
• Has the ability to get trained to run and review advanced assays as necessary.
• Identifies areas of improvement and works to implement them (i.e. 6S, document revisions, workorders, change controls).
• Communicates to other departments as appropriate (MFG, QA, MSAT, etc.) during operations and escalate issues as needed.
• Initiates and assists with investigations as required within the job functions.
• Drives audit readiness on the team with advanced regulatory knowledge. Conduct Pre-Audit walks through the laboratory space. Available to confidently and competently speak to auditors as QC SME.
• Apply Data Integrity principles in all aspects of work, in compliance with Client's DI policies, guidelines and procedures.
• Completes assigned tasks on-time and accurately, can identify needed tasks and complete without direction.
• Perform other duties as assigned

Education:

• Bachelors Degree with combination of education and years of experience will be considered
• Industry Experience, preferably in a cGMP environment (5-10 Years)