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Responsible for hiring, training, supervising, and performance management of staff
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Represent QA on local Change Control Review Board
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Disposition product lots
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Represent Quality on incident triage teams
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Review and approve Investigations
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Represent area of responsibility during regulatory inspections
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Develop and improve Quality Systems, programs and procedures to promote, facilitate, and ensure compliance with Amgen’s Quality Manual, domestic and international GMPs, regulatory and industry standards
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Bachelor's Degree in Life Sciences or related field.
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8+ years of related and increasingly complex quality assurance and/or manufacturing experience in the pharmaceutical industry.
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Experience in investigations, change control, validation and/or audits and 5+ years of experience in supervising larger multi-leveled work groups at a manager level.
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Expertise is required in solid dosage form pharmaceutical environment; including compounding, tablet compressing, coating and packaging processes. Knowledge is required in Analytical Chemistry with previous experience from a Pharmaceutical QC/QA environment and industrial application of various techniques including HPLC, GC, Content Uniformity and Dissolution tests in accordance to applicable pharmacopeias and regulatory environment.
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Experienced managing customer complaints and Field Alert reports.
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Previous management experience is essential, as is proven expertise of handling multiple tasks at once and performing to tight deadlines. Must be able to demonstrate leadership skills and the ability to communicate with people at all levels.
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Demonstrated ability to manage supervisors.
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Ability to delegate wisely and effectively.
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Works effectively with diverse departmental groups.
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Excellent team development and leadership skills.
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Skill and knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and process development.
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Commands respect from team, peers, and management.
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Thorough knowledge of CFRs, GMPs and pharmaceutical processing and demonstrated ability to apply.
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Able to make sound, quality decisions independently.
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Excellent communication (both written and verbal), facilitation, and presentation skills.
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Skilled in risk management
- Demonstrate the Amgen Values/Leadership Practices