Responsible for independently maintaining quality oversight of operational areas in the prevention, identification and resolution events both individually and through subordinate roles while following Good Manufacturing Practices (GMP). Provide leadership to a group of experienced or degreed Associates or Specialists. Also assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Cytovance Standard Operating Procedures.

Responsible for maintaining quality oversight of operational areas by working closely with Operation’s personnel and performing various checks during manufacturing processes to ensure that current Good Manufacturing Practices (cGMP’s) are followed. Support the CAPA System and Quality System requirements, to include initiating, authoring, reviewing, and approving (upon completed training requirements): Deviation Reports (DEV) Planned Deviations, Nonconforming Material Reports (NONC), and Corrective Actions (CA) for assessment and resolution of events. Interface with functional groups, such as Manufacturing, Quality Control, and Records Review, to determine events (errors, deficiencies, discrepancies, deviations and other observations).

Analytical chemistry and microbiology testing of environmental samples.