Specialist QA- 35768

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:

- Bachelors degree in Science or Engineering + 4 years of directly related experience.

PREFERRED QUALIFICATIONS:

- Perform On-the-floor Plant Quality Assurance (PQA) review, approval, and tracking of cGMP processes, procedures, testing methods in manufacturing, documents and records, batch record review, MES, EBR, SAP, EDMQ, DQMS, Trackwise; including but not limited to deviations, CAPAs, and validations.

- Actively engage in continuous improvement initiatives, programs, and projects.

- Vigilantly ensure that changes potentially impacting product quality are assessed according to procedures.

- Certify that deviations from established procedures are investigated and documented per procedures and ensure on-the-floor triage is completed, documented, and current procedural controls are achieved, including ensuring the initiation of deviation records.

- Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.

- Require strong collaboration and cross-functional partnership to ensure the Quality Management System, Manufacturing, Process Development, Validation, Quality Control, Warehouse, Engineering, Contractors, Environmental, Facilities, and other processes are executed according to established procedures.

- Serve as a strategic advisor to senior management regarding quality, compliance, supply, and safety risks.

- Support internal/external audits and inspections as part of the audit/inspection management team, including acting as Quality unit representative as needed.

- Accountable for adherence to assigned training, permitting execution of required tasks.

- Champion continuous improvement initiatives and projects.

- Provide support and oversight for New Product Introduction (NPI).

- Demonstrate validated expertise in Quality Systems such as deviations, CAPA, and change control.

- Exhibit experience in computer systems validation or computer systems quality assurance, particularly with medical devices and/or consulting background technical proficiency.

- Possess robust knowledge and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development.

- Experience with validation of GxP applications, including development of Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) protocols, test scripts, and completion/summary report approvals per compliance requirements.

- Validated experience serving as Quality Contact for complex projects involving new products.

- Validated experience in commissioning and qualification.

- Strong organizational skills, including the ability to follow assignments through to completion.

- Enhanced skills in leading, influencing, and negotiating.

- Demonstrate the ability to interact effectively with regulatory agencies.

- Solid word processing, presentation, database, and spreadsheet application skills.

- Strong communication skills in English and Spanish (both written and oral), facilitation, and presentation skills.

- Proven skill in working independently and effectively interacting with all levels throughout the organization.

- Advanced data trending and evaluation abilities.

- Ability to evaluate compliance issues.

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.

WORK METHODOLOGY:

- Full on site job in Juncos, PR

- Full time job

- Expected project duration: 5 months for the first contract with a high possibility of extension based on performance and budget.

- Non-Standard Shift (weekends and overtime may also be required).

- Expected hiring date: October 2026