Amgen Sr. Specialist QA in Juncos, Puerto Rico00777

SUMMARY

Amgen Manufacturing Limited is seeking a Sr. Specialist Quality Assurance (QA) to play a key role as part of the Nonconformance Class 3 investigation team. The Sr. Specialist QA role s expected to demonstrate a high level of professionalism, negotiation, and the ability to manage successfully multiple priorities. This is a unique opportunity to positively impact operations through process improvement, product quality and compliance.

SPECIFIC RESPOSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

Approve process validation protocols and reports for manufacturing processes.

Represent Quality on incident triage team.

Approve Environmental Characterization reports.

Release of sanitary utility systems.

Approve planned incidents.

Represent Quality Assurance (QA) on New Product Introduction team.

Lead investigations.

Own site quality program procedures.

Designee for Quality Assurance manager on as needed basis.

EDUCATION/LICENSES

Doctorate degree in Science or Engineering and 2 years of experience in pharmaceutical or biotechnology manufacturing environment

or

Master's degree in Science or Engineering and 6 years of experience in pharmaceutical or biotechnology manufacturing environment

or

Bachelor's degree in Science or Engineering and 8 years of experience in pharmaceutical or biotechnology manufacturing environment

PREFERRED QUALIFICATIONS

Expertise in root cause analysis and ability to transfer that knowledge to other staff

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, QC, validation, and processes development

Demonstrated 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

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.