BioPharma Consulting JAD Group is currently hiring for the position of Specialist QA.
As a Specialist QA, you will play a critical role in ensuring the quality and compliance of our products and processes.
FUNCTIONS Review and approve product Master Production Records (MPs).
Approve process validation protocols and reports for manufacturing processes.
Serve as a Quality representative on the incident triage team.
Approve Environmental Characterization reports.
Manage the release of sanitary utility systems.
Approve planned incidents.
Represent QA on New Product Introduction (NPI) teams.
Lead investigations and site audits.
Own and manage site quality program procedures.
Act as a designee for the QA manager on the local Change Control Review Board (CCRB).
Review Risk Assessments.
Support Automation activities and facilities/environmental programs.
Review and approve Work Orders.
Monitor and approve EMS/BMS alarms.
Approve Non-Conformance (NC) investigations and Corrective and Preventive Action (CAPA) records.
Approve change controls.
Provide lot disposition and authorize lots for shipment.
COMPETENCIES/SKILLS Strong project management and organizational skills, with the ability to follow assignments through to completion.
Ability to initiate and lead cross-functional teams, with enhanced skills in leadership, influence, and negotiation.
Strong knowledge in areas related to manufacturing, distribution, QA, QAL, validation, and process development.
Proven ability to interact effectively with regulatory agencies.
Proficiency in word processing, presentation, database, and spreadsheet applications.
Excellent communication (written and oral), facilitation, and presentation skills.
Ability to work independently and interact effectively with various organizational levels.
Advanced data trending and evaluation skills.
Ability to evaluate compliance issues and recommend corrective actions.
Demonstrate Amgen Values/Leadership Practices.
PREFERRED QUALIFICATIONS Quality Professional with experience in Manufacturing Process Audit and Batch Record Review.
Familiarity with DAI processes, PASx/MES applications, MAXIMO, SAP, and LIMS.
Availability for non-standard shifts, including nights and weekends.
Requirements EDUCATION/LICENSES 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 Associate's degree and 10 years of directly related experience, or High school diploma / GED and 12 years of directly related experience.
Shift: 4 days 12 hours a day.
