Specialist QA

Under minimal supervision, the Specialist QA supports the site Quality Assurance program by ensuring compliance with cGMP requirements, regulatory standards, and internal quality systems. The role provides oversight across manufacturing, environmental monitoring, critical utilities, validation, and quality systems, while driving continuous improvement and maintaining a strong contamination control posture.

FUNCTIONS

• 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.

COMPETENCIES & SKILLS

• 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.

EDUCATION REQUIREMENTS

• Doctorate OR
• Master’s + 2 years directly related experience OR
• Bachelor’s + 4 years directly related experience OR
• Associate’s + 8 years directly related experience OR
• High School/GED + 10 years directly related experience

Preferred:

• Bachelor’s or higher in Microbiology, Biology, Life Sciences, Engineering, Chemistry, Physics, or Computer Science.
• 10+ years in biopharmaceutical industry with 5+ years in Quality.

PREFERRED QUALIFICATIONS

• Extensive experience in Quality & Compliance, regulatory audits, validation, characterization, and automation validation.
• Strong background in reviewing/approving deviations, EM/CU trend reports, and contamination control documentation.
• Ability to identify quality, compliance, supply, and safety risks and escalate appropriately.

• Administrative Shift
• 1 Year contract