Amgen Sr Specialist Quality Compliance in Juncos, Puerto Rico
Under minimal, if any, supervision the Sr Specialist Quality Compliance role will contribute to the execution of Operations Regulatory Compliance department projects necessary to achieve corporate and departmental goals.
SPECIFIC RESPOSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
Evaluates and audits Quality Management Systems.
Participates, coordinates and may lead site inspectional readiness activities for domestic and foreign regulatory agency inspections.
Coordinates and develops domestic and international regulatory and compliance responses.
Participates as team member (in some cases may lead) in audits of manufacturing, testing, distribution, and contract facilities to ensure compliance with commitments made to Regulatory Authorities and cGMPs.
Identifies, interprets, and disseminates new regulatory trends, expectations and compliance documents. Assesses the state of compliance with appropriate regulations and participates in the development of action plans to correct deficiencies.
Serves as Quality Compliance representative in group meetings and works closely with other departments in order to achieve goals.
Independently reviews Manufacturing Procedures, SOPs, and other documentation to ensure compliance with commitments, regulations and filings.
Performs tasks, as assigned, to assist in the timely completion of activities associated with the attainment of group, departmental, and corporate goals.
Doctorate degree Life Sciences or Engineering and 2 years of experience in pharmaceutical, medical device and/or biotechnology manufacturing environment.
Master's degree Life Sciences or Engineering and 6 years of experience in pharmaceutical, medical device and/or biotechnology manufacturing environment.
Bachelor's degree in Life Sciences or Engineering and 8 years of experience in pharmaceutical, medical device and/or biotechnology manufacturing environment.
Internal and External audits program readiness.
Experience working directly with regulatory agencies.
Experience in the medical devices industry.
Written and verbal communication skills including technical writing skills in English & Spanish languages.
Knowledge of U.S. and P.R. regulations and practices pertaining to the manufacture and testing of pharmaceutical/biological products and/or medical devices.
Ability to work in a team or matrix environment.
Ability to collaborate and coordinate with internal and external depts./groups/resources.
Analytical problem solving skills.
Ability in handling multiple and complex responsibilities, tasks and projects simultaneously.
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.