Specialist QA (31747) – Juncos, PR

Requirements Education & Experience
Master’s degree and 3 years of Quality or Manufacturing support experience in pharmaceutical, GMP regulated environment Or Bachelor’s degree & 5 years of Quality or Manufacturing support experience in pharmaceutical, GMP regulated environment

Preferred Qualification
• Educational background in Life Science and/or Engineering.
• Experience in computer systems validation or computer systems quality assurance (consulting background technical proficiency).
• Robust knowledge of and experience with processes involved in manufacturing and distribution, QA, QC, and Process Development.
• Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements.
• Validated experience as Quality Contact for complex projects involving drug substance/products with experience in commissioning and qualifications.
• Strong organizational skills, including ability to follow assignments through to completion.
• Enhanced skills in leading, influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.
• Microsoft Office spreadsheet and application skills and presentation knowledge.
• Strong communication (both written and oral), facilitation and presentation skills. Fully Bilingual in English and Spanish.
• Validated skill in working independently and to optimally interact with all levels throughout the organization.

Non-standard shift 5pm – 5:30am

Description:
Client requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment. In accordance with applicable law, client will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to client, its operations, or its staff.

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/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.

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.