Quality Assurance

·The scope of work for this role is to provide QA Validation support to validation activities associated with Quality Control (QC) Laboratory instruments. The main responsibility is review and approval of validation documentation including specifications, executed protocols, summary reports, deviations, periodic reviews, procedures, and change controls. In addition, this role may provide support to the site’s data integrity initiative

·Successful candidate requires a strong working knowledge of global GMPs with an emphasis on validation lifecycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures.

·Candidate requires strong interpersonal, oral and written communication skills as there is a high degree of collaboration required between members of QA Validation, Instrument Validation and QC personnel.

·Candidate must be detail oriented as the main job responsibility is review and approval of validation documentation.

·Candidate must have at a minimum a BS in biology, engineering or related sciences with at least 3 years of pharmaceutical or biopharmaceutical experience in a quality assurance and/or validation role.

·Past experience working with QC instrumentation, Labware, Trackwise, and/or Documentum in the pharma/biopharmaceutical field is preferred but not required.