Senior Specialist, QA Compliance Materials ManagementApply locations Cruiserath - IE time type Full time posted on Posted 4 Days Ago job requisition id R1588108
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Position Summary BMS Cruiserath Biologics is looking to hire a Senior Specialist in QA Compliance for Materials Management on a 12-month temporary fixed-term contract.
Reporting to the Senior Manager, QA Compliance Materials Management, the Specialist will support the material qualification and release activities for the Cruiserath manufacturing facility for its biologics commercial portfolio and clinical pipeline.
Key Responsibilities Preparation, review and approval of Material Qualification Documentation.QA disposition of raw materials, level 1 & level 2 consumables.Authoring, review and approval of QA-related procedures.QA review, assessment and approval activities for Biologics Manufacture, as applicable, for:Change controlsDeviations/InvestigationsSupplier InvestigationsCAPAsSupplier Change Notifications (SCN)TSE (Transmissible Spongiform Encephalopathy) CertificatesOther associated documentationBe a core team member of the QA Compliance Materials Management team engaging in other support activities as required.Support establishment of Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.Qualifications & Experience The successful candidate must possess:
BSc in Science or related discipline with a minimum of 3 years' QA or related experience in a Biologics or Pharmaceutical environmentA clear understanding of cGMP requirements for manufacturing and/or systems and complianceKnowledge of material qualification & SAP would be a distinct advantage.Required to work on his/her own initiative in addition to working as part of a team.
Must be able to work across a team matrix to meet accelerated timelines.Excellent communication and presentation skills are essential.Excellent time management and organizational skills along with a proven ability to multi-task.Employees are expected to display the BMS Biopharma Behaviors, which enable them to be successful and perform at their highest level.Why you should apply You will help patients in their fight against serious diseasesYou will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employeesYou'll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical assurance, 27 day annual leave, life assurance and on-site gym#LI- Hybrid
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