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:

• Doctorate degree or Master's degree and 3 years of directly related experience.
• Bachelor's degree and 5 years of directly related experience.
• Associate's degree and 10 years of directly related experience.
• High school diploma / GED and 12 years of directly related experience.
• Background in Life Science and/or Engineering.

Preferred Qualifications:

• Perform Trackwise system queries, deviations.
• Participate in triage process.
• Perform oversight of the process and procedures/ GMP tasks.
• Manage Change Controls and deviations for review and approval as QA contact.
• Work with operations to resolve basic compliance discrepancies.
• Knowledge in Validations and Laboratory area and equipment.
• 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.

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
• Full time opportunity
• 11 months (1st Contract)
• Administrative shift (weekends and overtime may also be required).
• Professional Service Contract