Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience
Bachelor’s degree in sciences, preferably Biology, Chemistry, Engineering with a minimum of 5 years’ experience in support to manufacturing operations, deviations, change controls, work orders and environmental logbooks.
1. Teamwork and collaboration
2. Bilingual (English and Spanish)
3. Science Based
4. Willing to work on weekends and holidays
This position is recruit to support Quality Systems increase workload due to a run rate increase, to support deviations, change controls and reports revision. However, a PQA on the floor experience is needed to support manufacturing shifts as the area to be assigned.
Client requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment at site. In accordance with applicable law, the client will provide reasonable accommodations to staff augmentation external workers who qualify based on a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to the client, its operations, or its staff. Perform one or more of the following duties and responsibilities in support of client’s Quality Assurance program under minimal supervision. Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Lead site audits. Own site quality program procedures. Designee for QA manager on local CCRB. Review Risk Assessments. Support Automation activities. Support facilities and environmental programs. Review and approve Work Orders. Review and approve EMS/BMS alarms. Approve NC investigations and CAPA records. Approve change controls. Provide lot disposition and authorize lots for shipment. Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associates degree and 10 years of directly related experience.
Project management skills, Strong organizational skills, including ability to follow assignments through to completion, Initiate and lead cross functional teams, Enhanced skills in leading, influencing and negotiating, Strong knowledge in area of expertise, Collaborate and coordinate with higher level outside resources, Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development, Demonstrate ability to interact with regulatory agencies, Strong word processing, presentation, database and spreadsheet application skills, Strong communication (both written and oral), facilitation and presentation skills, Strong skill in working independently and to effectively interact with various levels, Advanced data trending and evaluation ability to evaluate compliance issues, Demonstrate the Amgen Values/Leadership Practices.