SUMMARY
Are you a Quality expert with a vast knowledge in manufacturing process? Amgen is looking for a Specialist Quality Assurance to support a non-standard shift organization within our Drug Substance Manufacturing operation at Puerto Rico site, Amgen Manufacturing Limited. As Specialist QA, you will bring forth out of the box thinking, an agile mindset and proven subject matter expertise and innate understanding of Quality processes and controls in support to a large-scale 24/7 manufacturing plant -AML7.
Will support the execution of manufacturing/quality systems such as batch record review, non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.
Through a superior Quality oversight on-the-floor operations, this role will be responsible to ensure that pharmaceutical products are manufactured, tested, stored, and distributed according to cGMP practices and other applicable regulations, in addition to facilities, equipment, materials, organization, processes, procedures and products
THE DEPARTMENT
The AML-7 Facility is the home of elite, multi-product Drug Substance Manufacturing Operations. The facility highlights the combination of groundbreaking manufacturing sciences and process technology, advanced equipment engineering and automation, and a culture of opportunities integrating cross-functional teams from across the site with the goal of achieving being the best drug substance manufacturing facility in the world.
SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
Perform review, approval and tracking of cGMP processes, procedures, testing (methods) in manufacturing, documents and records, including but not limited to Batch Records, Deviation’s, CAPAs, and validations
Perform thorough Quality oversight in GMP Operational Areas to ensure adherence to established processes, procedures, and compliance requirements
Actively engage in Continuous Improvement initiatives, programs and projects
Vigilantly ensure that changes that could potentially impact product quality are assessed according to procedures
Certify that deviations from established procedures are investigated and documented per procedures
Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements
To be successful, you will be required to:
Strongly collaborate and partner cross functionally to ensure the Quality Management System processes are executed in accordance with established procedures
Strategically advise to senior management of quality, compliance, supply and safety risks
Support internal/external audits and inspections as part of the audit/inspection management team including acting as Quality unit representative as needed
Demonstrate accountability for assigned training adherence to permit execution of required tasks
Provides support and oversight of New Product Introduction (NPI)
BASIC QUALIFICATIONS - EDUCATION/LICENSES
Bachelor’s degree & 5 years of Quality and/or Manufacturing experience in a GMP regulated industry
OR
Master’s degree & 3 years of Quality and/or Manufacturing experience in a GMP regulated industry
OR
Doctorate degree
PREFERRED QUALIFICATIONS
Education field in Life or Computer Sciences and/or Engineering
Validated expertise in Batch Record Review, Quality Oversight, and Quality Systems such as Non-Conformance, CAPA and Change Control
Knowledge and experience in Manufacturing Execution Systems (MES)
Robust knowledge in Data Integrity
Robust knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development
Strong organizational skills, including ability to follow assignments through to completion
Good communications skills (oral and written) and comprehend in English and Spanish
Enhanced skills in leading, influencing and negotiating
Experience interacting with regulatory agencies
Solid word processing, presentation, database and spreadsheet application skills
Experience in developing and managing data repositories (Smartsheet, BOX, etc.)
Strong communication (both written and oral), facilitation and presentation skills
Ability for multi-tasking and project management
Proven skill in working independently and to effectively interact with all levels throughout the organization
Advanced data trending and evaluation
Ability to evaluate compliance issues
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.
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do.
We equip all our staff members to live well-rounded, healthy lives. Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.
Amgen focuses on areas of high unmet medical need and uses 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.
Join Us
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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.
