Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
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. The 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. The candidate must have 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. The candidate must be detail oriented as the main job responsibility is review and approval of validation documentation. A minimum of 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 is required. Past experience working with QC instrumentation, Labware, Trackwise, and/or Documentum in the pharma/biopharmaceutical field is preferred but not required.
Responsibilities:
- Review and approval of validation documentation including specifications, executed protocols, summary reports, deviations, periodic reviews, procedures, and change controls
- Provide support to the site’s data integrity initiative
- Collaborate with members of QA Validation, Instrument Validation and QC personnel
