We are seeking a highly skilled Quality Assurance Specialist to perform a variety of responsibilities in support of its Quality Assurance (QA) program.
This role requires minimal supervision and involves collaborating with cross-functional teams to ensure compliance with manufacturing, validation, and process development standards.
Responsibilities: Review and approve product manufacturing procedures (MPs).
Approve process validation protocols and reports for manufacturing processes.
Participate as a QA representative on incident triage teams.
Approve environmental characterization reports.
Release sanitary utility systems.
Approve planned incidents and represent QA on New Product Introduction (NPI) teams.
Lead investigations and site audits.
Own and manage site quality program procedures.
Serve as QA Manager designee on local Change Control Review Boards (CCRB).
Review and approve risk assessments, work orders, and EMS/BMS alarms.
Support automation activities, facilities, and environmental programs.
Approve non-conformance investigations, CAPA records, and change controls.
Provide lot disposition and authorize lots for shipment.
Skills & Competencies: Project Management: Ability to manage complex projects and follow through to completion.
Leadership: Strong skills in leading, influencing, and negotiating within cross-functional teams.
Technical Expertise: Advanced knowledge of manufacturing and distribution processes.
Familiarity with QA, QAL, validation, and process development.
Experience interacting with regulatory agencies.
Technical Tools: Proficiency in word processing, presentations, databases, and spreadsheets.
Communication: Strong written, oral, facilitation, and presentation skills.
Compliance: Ability to evaluate compliance issues and advanced data trending and evaluation.
Problem Solving: Exceptional organizational and analytical skills to work independently and resolve issues.
Values: Demonstrate Amgen's Values and Leadership Practices.
Requirements Education & Experience Requirements: Doctorate degree OR Master's degree with 3 years of directly related experience OR Bachelor's degree with 5 years of directly related experience OR Associate's degree with 10 years of directly related experience OR High school diploma/GED with 12 years of directly related experience.
Preferred Background: Degree in Science or Engineering.
Experience in manufacturing process audits and batch record review.
Familiarity with DAI process, PASx/MES application, MAXIMO, SAP, and LIMS.
Availability for non-standard shifts, including nights and weekends.