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Specialist QA-34383

Juncos, Puerto Rico
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:
  • Masters + 2 years of directly related experience.
  • Bachelors + 4 years of directly related experience.
  • Science or Engineering bachelor.
  • Pharmaceutical environment experience.
  • Spoken languages: Spanish and English.
Preferred Qualifications:
  • Experienced quality assurance specialist.
  • Commissioning and Qualification of Equipment/Systems/Facilities.
  • Auditing Equipment/Facilities/Utilities of Qualification Protocols and execution.
  • Revision and approvals of technical documents like URS, Design, Report of technical data.
  • Deep knowledge of quality assurance terminology, methods, and tools.
  • Knowledge on Veeva, CDOCS applications.
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: 
  • 100 % On-Site
  • 12 months (1st Contract)
  • Administrative Shift (weekends and overtime may also be required).
  • Professional  Services Contract 

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