Careers

The Manager Quality Control Microbiology manages the Quality Control Microbiology/Environmental Monitoring Laboratory.

Responsibilities:

• Provide technical expertise with microbiological and chemical test procedures, methods, and equipment within the QC Laboratory of a Biopharmaceutical, CGMP Manufacturing Facility.
• Ensure CGMP compliance across the quality control microbiology functions.
  
• Oversees and directs product testing program including product stability testing, raw material testing, product inprocess and release testing, water and environmental testing to assure conformance to specification, action or alert limits; confirm safety of material, equipment and process environment for continued production.
• Directs data trending and summarization.
• Implements and maintains quality control systems related to Microbiology/EM and raw materials testing.
• Development of staff to improve individual and departmental performance.
• Responsible for training of employees in the QC Micro, Environmental Monitoring and QC raw materials sampling and release functions.
  
• Balancing of priorities and resolution of conflict inter- and intra- departmental.
• Oversees the review of data generated in the laboratory prior to release of information.
• Documents and reviews test results in order to meet regulatory requirements.
• Attends meetings to support projects, validations, production efforts and testing scheduling.
• Organize testing associated with product, cleaning validations and equipment qualifications.
• Oversees the outsourced testing for the QC Micro Lab.
• Oversees validation of test methods to support the release of materials for production or products for commercial or clinical use.
• Oversees validation of test methods to support the release of materials for production or products for commercial or clinical use.

Qualifications:

• Four year scientific degree with five + years of relevant experience working within a Quality Control Lab of a FDA regulated business, preferably pharmaceutical production.
• Certified Quality Auditor (CQA) ASQC
• Experienced with laboratory instruments, procedures and test methods: TOC, ELISA, LAL, electrophoresis, particulate content, material identification, host-cell DNA or protein, bioburden, sterility, mycoplasma, viral contamination, environmental monitoring, etc.
• Knowledgeable in OOS investigations, GLPs and GMPs.
• Ability to read and interpret technical procedures, FDA Guidelines and professional journals.
• Strong written and oral communication skills, detail-oriented and ability to work within multifunctional teams, and ability to prioritize work.
  

To apply for this position, please submit your resume including the position you are applying for to careers@cytovance.com or send it via postal service to Human Resources, 840 Research Parkway, Suite 400, Oklahoma City, OK 73104.