Specialist QA- 35619

SUMMARY
Perform one or more of the following duties and responsibilities in support of Amgen's Quality Assurance program under minimal supervision.

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.

EDUCATION:

• Doctorate or -Masters + 2 years of directly related experience.
• Bachelors + 4 years of directly related experience.
• Associates + 8 years of directly related experience.
• High school/GED + 10 years of directly related experience.

PREFERRED QUALIFICATIONS:

• The candidate should poses a BS in Science, Engineering, Physics, Biology, Chemistry or related fields. It should have experienced working in biopharmaceutical industry, quality organization supporting deviations, validation reports, qualifications, investigations, at least 5 years of experienced in a highly regulated environment .

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.

WORK METHODOLOGY:

• Full- time job
• Full on-site job
• Location: Juncos, PR
• Expected hiring month: September 2026
• Initial contract term: 12 months for the first contract with a high possibility of extension based on performance and budget.
• Number of openings: 1
• Administrative Shift (weekends and overtime may also be required).
• Professional services contract