Job Description SUMMARY In support of Amgen's Quality Assurance program acts as the technical specialist in the Reserve Samples Program. SPECIFIC RESPOSIBILITIES INCLUDE BUT ARE NOT LIMITED TO: Review and approve product MP's Approve process validation protocols and reports for mfg. Processes Represent Quality on incident triage team Approve Environmental Characterization reports Release of sanitary utility systems Approve planned incidents Represent QA on NPI team Lead investigations Own site quality program procedures Designee for QA manager EDUCATION/LICENSES Doctorate degree in Pharm.D, Life Sciences or Engineering and 2 years of experienece in pharmaceutical, medical devices or biotechnology manufacturing environment or Master's degree in Life Sciences or Engineering and 6 years of experienece in pharmaceutical, medical device or biotechnology manufacturing environment or Bachelor's degree in Life Sciences or Engineering and 8 years of experience in pharmaceutical, medical device or biotechnology manufacturing environment PREFERRED QUALIFICATIONS Proven Managerial Skills Strong knowledge in Good Distribution Practices Experience in Warehouse Operations such as Receiving, Shipping and Transportation Project management and organizational 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 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.
Ciudad: juncos
