Title: QA Specialist - 35615

Location: Juncos, Puerto Rico

Important Notice: This opportunity is available only for direct individual candidates. Third-party contractor submissions, staffing vendors, and Corp-to-Corp (C2C) arrangements will not be considered for this position.

Work Schedule: Onsite | Administrative Shift (Must be available to work overtime, alternate shifts, weekends, and holidays based on business needs.)

Contract Duration: 1 year

Open Position: 1

SUMMARY

Position Summary

Our client is seeking a highly motivated QA Specialist to support its Quality Assurance program. The selected candidate will perform a variety of quality assurance activities with minimal supervision while ensuring compliance with quality standards, regulatory requirements, and internal procedures.

Key Responsibilities

• Review and approve product manufacturing protocols (MPs).
• Review and approve process validation protocols and reports for manufacturing processes.
• Serve as the Quality representative on incident triage teams.
• Review and approve Environmental Characterization reports.
• Authorize the release of sanitary utility systems.
• Review and approve planned incidents.
• Represent Quality Assurance on New Product Introduction (NPI) teams.
• Lead quality investigations and ensure timely resolution.
• Lead internal and site quality audits.
• Own and maintain site Quality Program procedures.
• Serve as the QA Manager's designee on the local Change Control Review Board (CCRB).
• Review and approve Risk Assessments.
• Support automation-related quality activities.
• Provide quality support for facilities and environmental programs.
• Review and approve maintenance Work Orders.
• Review and approve EMS/BMS alarms.
• Review and approve Non-Conformance (NC) investigations and CAPA records.
• Review and approve Change Control documentation.
• Perform lot disposition activities and authorize product lots for shipment.

Minimum Qualifications

Candidates must meet one of the following education and experience combinations:

• Doctorate degree.
• Master's degree with 2 years of directly related experience.
• Bachelor's degree with 4 years of directly related experience.
• Associate's degree with 8 years of directly related experience.
• High School Diploma or GED with 10 years of directly related experience.

Preferred Qualifications

The ideal candidate will have experience in Quality Assurance within a regulated manufacturing environment, including:

• Validation, Commissioning, and Qualification (CQV) of manufacturing and laboratory equipment.
• Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Functional Testing.
• Technical writing and documentation.
• Quality Systems, including Deviations, Change Control, and CAPA.
• Maintenance processes, including Preventive Maintenance (PM), Work Orders, and Job Plan review and approval.
• Review and approval of technical documentation, including:
• Validation reports
• Technical reports
• Procedures
• Forms
• Process validation documentation
• Cleaning validation documentation



Required Skills & Competencies

• Strong project management and organizational skills.
• Ability to manage multiple priorities and drive assignments through completion.
• Experience leading cross-functional teams and collaborative initiatives.
• Excellent leadership, influence, and negotiation skills.
• Strong technical knowledge within Quality Assurance and regulated manufacturing environments.
• Experience collaborating with internal stakeholders and external partners.
• Solid understanding of manufacturing, distribution, validation, quality assurance, and process development.
• Ability to interact effectively with regulatory agencies during inspections and audits.
• Advanced proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and database systems.
• Excellent written and verbal communication skills, including facilitation and presentation abilities.
• Ability to work independently while building effective relationships across all organizational levels.
• Experience with data trending, analysis, and performance evaluation.
• Strong analytical skills with the ability to assess compliance risks and recommend appropriate actions.
• Demonstrated commitment to quality, continuous improvement, and operational excellence.

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 OR

-Bachelors + 4 years of directly related experience OR

-Associates + 8 years of directly related experience OR

-High school/GED + 10 years of directly related experience.

Prefere Qualifications

Quality Professional with Validations and Commissioning & Qualifications of manufacturing equipment and laboratory bench equipment experience (IOQ, PQ, Functional Test). In addition to Technical Writing, Quality Systems (Deviations, Change Control) and Maintenance (PM, Work Orders, Job Plans review and approval) knowledge. Technical Documents review and approval (Reports, Technical reports, Procedures, Forms) of process and cleaning validation.

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.