Specialist 3 - Validation

Titusville, PAContract Duration: 11-24 monthsRate: NegotiableSalary: NA $1.00Responsibilities:Excellent employment opportunity for a Specialist 3 - Validation in the Titusville, PA area.With Quality oversight, support the review and approval of equipment and process qualification/validation protocols and reportsWith Quality oversight, support the review and approval of process flow diagrams/product descriptions and subsequent master batch records - focus on large molecule cell expansion/bioreactor/purification manufacturingWith quality oversight, support the investigation related to manufacturing deviationsReview batch documentation provided by contract manufacturers (CMO) and responsible for product release in accordance to Company Supply Chain proceduresEnsure all required testing and documentation are provided and met release requirements.Review CMO Certificates of Conformance for batch release.Verify CMO certificates contain required information to confirm compliance of product to GMP, Company Specification and Quality Agreement requirements.Ensure all documents are in compliance with good documentation practice, data integrity, and accuracy of batch information, including but not limited to lot number, expiry date, within target ranges, etc.Ensure required Certificate of Analysis and Certificate of Conformance from bulk manufacturers and external laboratories are included and met specification.Ensure documentation review meets the requirements as specified for each productGenerate Company certificate of releaseMaintain high level oversight of individual batch releases; able to give accurate, succinct updates on particular batch release status.Alert Supervision of any nonconforming results, out of trend, or out of specification results.Support supply chain logistics for on time shipment from CMO to WarehouseComplete and pass all applicable training required for access to the systemsComplete and pass all applicable training for Good Manufacturing Practice and quality requirement training Experience:Bachelor's Degree in a scientific function, or equivalent degree level, with minimum of 6+ years of healthcare industry experienceExperience in quality function in Biologics or Vaccine industry preferredPrevious experience in work environment under cGMP regulation highly desirableMust have strong ability to maintain high efficiencies and accuracy in data entry.Strong proofreading skills to validate complex information and detect errorsStrong quantitative and analytic abilities to analyze and validate dataAbility to maintain and organized record file is essentialStrong computer skills in Excel, Word, SharepointAbility to follow standard operating procedures and work instructions.Good interpersonal, communication and organization skills.