Job Description
Job Description
Title: Specialist QA (Regulated Industry) – Req. 3517986
Location: 100% Onsite, Administrative Shift – Open for Puerto Rico Residents
Positions Available: 1
Contract Duration: Approximately 5 months
Contract through: ProQuality Network
Summary
As a Specialist QA, you will perform one or more duties in support of Amgen’s Quality Assurance program with minimal supervision. This role ensures compliance with regulatory standards and supports quality operations in a regulated manufacturing environment.
Preferred Qualifications
- Experience with NPI (New Product Introduction)
- Change Control management
- FAT (Factory Acceptance Testing)
- Validation and PPQ (Process Performance Qualification)
Key Responsibilities / Functions
- Review and approve product Master Production Records (MPs)
- Approve process validation protocols and reports for manufacturing processes
- Participate in incident triage as requested by Quality
- Approve Environmental Characterization reports
- Release sanitary utility systems
- Approve planned incidents and deviations
- Represent QA on NPI teams
- Lead investigations and root cause analyses
- Conduct and lead site audits
- Maintain ownership of site quality program procedures
- Serve as designee for QA Manager on local CCRB
- Review risk assessments and provide guidance
- Support automation initiatives
- Support facilities and environmental programs
- Review and approve Work Orders
- Review and approve EMS/BMS alarms
- Approve nonconformance (NC) investigations and CAPA records
- Approve change controls
- Provide lot disposition and authorize shipment
Education Requirements
- Doctorate OR
- Master’s degree + 2 years of directly related experience OR
- Bachelor’s degree + 4 years of directly related experience OR
- Associate’s degree + 8 years of directly related experience OR
- High School/GED + 10 years of directly related experience
Competencies / Skills
- Project management and organizational skills, with the ability to follow assignments through completion
- Ability to initiate and lead cross-functional teams
- Strong leadership, influencing, and negotiation skills
- Expert knowledge in QA, QAL, validation, and process development
- Experience interacting with regulatory agencies
- Proficiency in word processing, presentation, database, and spreadsheet applications
- Strong written and oral communication, facilitation, and presentation skills
- Ability to work independently and effectively collaborate at all organizational levels
- Advanced data trending and evaluation capabilities
- Ability to assess compliance issues accurately
- Demonstrated alignment with Amgen Values and Leadership Practices
This is a contract position through ProQuality Network.
We encourage interested candidates to apply directly through the job description link with an updated resume for consideration.