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 Client Values/Leadership Practices.
• *Weil Group is proud to be an Equal Employment Opportunity Employer
Juncos Puerto Rico

Salary Criteria