QC Analyst

Job Description:

• 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.

• 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 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.

Skills

• Comprehend and follow instructions.  
• Exercises judgement within defined procedures and practices to determine appropriate action.  
• Strong ability to interpret data both alone and with guidance.  
• Works entire assigned shift, including arriving on time.  
• Timeliness in completing assigned tasks.  
• Strong communication skills, both written and verbal format.  
• Self-motivated team player, relate to others in a team environment.  
• Maintain a positive and professional attitude within the team environment.  
• Completes assignments on-time and accurately, with minimal re-work.  
• Displays commitment to quality and performs job functions to the best of their ability. 
• Perform assigned, complex and/or varied tasks.  
• Prioritization and problem solving.  
• Direct, control and plan tasks/projects.  
• Brainstorming.