Pfizer Sr. Specialist QO in Kalamazoo, Michigan
ROLE SUMMARYThis posting is for a Sr Specialist QO in the Analytical Services group. The Analytical Services group is responsible for the Kalamazoo site Stability, Retain, and Reference Standard programs. This position will support a combination of these programs and is responsible for ensuring they remain in compliance with both internal and external regulatory requirements through maintenance of area standard operating procedures and training documents, understanding of requirements for handling and storage of controlled substances, and equipment monitoring and periodic reviews. The successful candidate will provide guidance and support to technicians in the area, represent the unit on cross functional project teams, and function as a subject matter expert during audits.ROLE RESPONSIBILITIESWork with operations schedulers to order stability lots required by SLS stability protocols, provide lot information obtained from SAP, LIMS, and various other sources to SLS stability group to ensure appropriate study creation in LIMS, and ensure samples are transferred to the appropriate storage conditions according to a defined schedule. Ensure samples are pulled and delivered to labs for testing at appropriate intervals.Maintain an appropriate inventory of characterized Reference Standards needed by the Kalamazoo QO Laboratories. Obtain bulk standard material, submit samples to appropriate labs for required testing, author and/or review characterization reports, create certificates of analysis, manage inventory in LIMS stock management module, and fulfill laboratory orders as needed.Ensure appropriate processing of Retain samples and compliance with annual inspection schedule.Assist team members and customers in investigation and resolution of items outside of the routine workload.Assist customers with special requests or needs.Lead or contribute to special projects.Process revisions to documents and test plans using local change control systems.Participate in system development and design.Interact with individuals at a variety of levels in the following areas: Operations, Quality Operations Laboratories, Quality Assurance, Complaints, SLS Stability.Meet performance metrics for supported programs.QUALIFICATIONSBachelors Degree (science or related field is preferred)Minimum of five years related experienceExcellent organizational skills and demonstrated ability to meet changing deadlines and deliver results on timeExcellent communication skills to support all levels of customers and maintain effective customer relationshipsDemonstrated agilityerformance in a changing environment and have a willingness to be active in continuous improvement initiativesDemonstrated ability to work both independently and in a team environmentDemonstrated commitment to values based leadership and achieving objectives in a manner that is supportive of Pfizer Values and Core CompetenciesKnowledge and use of quality systems (e.g. LIMS, SAP, QTS) is requiredAbility to comprehend and apply information from guidance documents (e.g. PQS, CFR) to functional processesFamiliarity with Stability, Reference Standards, and Retains programs preferredAnalytical laboratory experience preferredPHYSICAL/MENTAL REQUIREMENTSAbility to lift up to 35 poundsNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTSOff-hours/on-call support is required on a rotational basis.