The Quality Assurance Specialist will be responsible for PQA Off the Floor support and activities (Administrative shift). The PQA off the floor team is a centralized team supporting AR5, AR30 and the entire ARI. The team provides coaching, guidance and direction to Manufacturing, Quality Control, Process Development, Supply Chain, Facilities & Engineering and IS staff regarding quality systems and compliance.
Responsibilities include the following:
- Provide Quality oversight to Major Deviations, Change Controls, CAPAs/EVs, New Product Introductions (NPIs), Product Re-Introductions (PRIs) and Master Batch Records (MBRs) to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
- Ensure that changes that could potentially impact product quality are assessed according to procedures.
- Ensure that Facilities, Equipment, Materials, Manufacturing processes, Procedures and Products comply with cGMP practices and other applicable regulations.
- Provide Quality oversight to Document Management Systems records (CDOCs and GDMS)
- Establish and enable LEAN practices.
- Drive operational improvement initiatives and projects.
- Support Audits and Inspections
Master's degree and 3 years of Quality, Manufacturing, Process Development or Process Engineering experience
Bachelor's degree and 5 years of Quality, Manufacturing, Process Development or Process Engineering experience
Associate's degree and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience
High school diploma / GED and 12 years of Quality, Manufacturing, Process Development or Process Engineering experiencePreferred Qualifications
Scientific degree in Life Sciences or Physical Sciences or Applied Engineering or Manufacturing Technologies
Experience in QA oversight of manufacturing, analytical and engineering activities
Experience in investigations, change controls, and CAPAs processes system knowledge
Ability to evaluate compliance issues and interact with regulatory inspectors
Experience and training in Trackwise, CDOCS, Maximo, LIMS
Experience in managing multiple, competing priorities in a fast-paced environment
Direct bulk drug substance and drug product experience
Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff.
Ability to problem solve and make scientific risk-based decisions
Demonstrated proficiency using Excel, Word, Power Point, Smartsheet and Teams
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.
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.
Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.