Description
Job Description QUALITY SPECIALIST II WITH PHARMACEUTICAL VACCINE WEST POINT, PA Onsite. Project Description: Support Global Complaint Management as a point of contact responsible for monitoring the MDCP Quality Complaints mailbox. Manage and serve as a global point of contact for the daily monitoring and processing of MDCP complaints and adverse events in the QCC4 IT system. Review reportable external customer complaints, upon intake, for appropriateness for health authority submission. Document review/approval in complaint IT system. Support the processes with regional Complaint Handling Units, Complaint Investigation Units at internal and external sites, Technical and Safety groups to ensure robust CAPAs are put in place, and the design of the device and device components are adequately considered when manufacturing or packaging root causes are not identified. Support the processes to review the Device Risk Management Files to ensure the customer complaint being investigated is appropriately represented and collaborate with Technical and Safety groups to update Risk Files as required. Support the processes to review and approve reportable external customer complaint investigation reports prior to their submission to health authorities. Assist with other reporting and trending/analytic requirements, including but not limited to PMPR, PAER, AMR, high risk quarterly and monthly product trending. Other activities as directed by Director, Complaints & Device Quality Required Skills: Bachelor's degree. Technical emphasis in an appropriate scientific or engineering field preferred; candidates with majors in other fields will be considered if accompanied by significant relevant experience. At least one year of relevant post-degree work experience in a laboratory, manufacturing, or quality position. Evidence of good oral and written communication skills, i.e., effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills. Attention to detail, flexibility and an awareness of production and attendant quality control problems. Basic understanding of GMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area. Familiarity with vaccine and/or pharmaceutical processing. Familiarity with medical device and combination products a strong plus. Familiarity with computer systems (Trackwise, SAP, LIMS, electronic batch records) is a plus. This 6 month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: ALPHA'S REQUIREMENT #22-00860 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
