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For your reference, we have included the original job posting below.
Sr Mgr QA
Job Number:
43432614
Company Name:
Amgen
Job Location:
Juncos, PR US
Job Categories:
Engineering & Architecture Manufacturing & Production
Sr Mgr QA
SUMMARY
In support of Amgen's Quality Assurance program manages and oversees the QA operations of a manufacturing plant or support area (component preparation, formulation and filling of an aseptic operation)
FUNCTIONS
1. Responsible for hiring, training, supervising, and performance management of staff. 2. Represent QA on local Change Control Review Board, Non-conformance Review Board and CAPA Review Board 3. Disposition product lots. 4. Represent Quality on incident triage teams 5. Review and approve Investigations. 6. Represent area of responsibility during regulatory inspections. 7. 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.
** Other functions that may be assigned.
**Candidates must be available to work first, second and third shift.
Basic Qualifications Basic Education & Experience • Bachelor's degree & 8 years of directly related experience OR • Master's degree & 6 years of directly related experience OR • Doctorate degree & 2 years of directly related experience
AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
COMPETENCIES/SKILLS
• Demonstrated ability to manage staff and/or supervisors. • Ability to delegate wisely and effectively. • Works effectively with diverse departmental groups. • Excellent team development and leadership skills. • Skill and knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and process development. • Commands respect from team, peers, and management. • Thorough knowledge of CFRs, GMPs and pharmaceutical processing and demonstrated ability to apply. • Able to make sound, quality decisions independently. • Excellent communication (both written and verbal), facilitation, and presentation skills. • Skilled in risk management • Demonstrate the Amgen Values/Leadership Practices
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