Specialist QA - Deviation Lifecycle DP
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
The Specialist QA role will be a member of the Deviation Lifecycle Team, supporting investigations to major deviation investigations and associated Corrective Action Preventive Action (CAPA) and CAPA EV records along with all the associated GMP documentation (procedures, testing results, risk assessments, etc). This position will focus in supporting AML Drug Product Operations consists of 3 plants, AML-14 - Formulation and Filling, AML-1 - Inspection and Packaging, , and AML-23 - Solid dosage, as well as the Process Development and Supply Chain Operations. The incumbent will be responsible to provide quality direction and establish requirements for the site major deviations.
What you will do
Lets do this. Lets change the world. In this vital role you will bring forth out of the box thinking, an agile attitude and proven subject matter expertise and innate understanding of Quality processes in drug product operations, including formulation, filling, inspection, assembly, packaging, and solid dosage operations. You will be responsible for the quality and compliance of major deviations.
- Responsible for Major Deviations, CAPAs, CAPA EVs as Quality contact and all associated documents which include GMP document revision, and Quality System records with role of Quality contact.
- Ensures true Root Cause are identified and appropriate corrective actions are implemented.
- Ensures that facilities, equipment, materials, organization, processes, procedures and products align with cGMP practices and other applicable regulations
- Supports Continual Improvement initiatives, programs and projects
- Ensures that deviations from established procedures are investigated and detailed per procedures
- Ensures that Quality Assurance personnel are qualified and trained to perform assigned functions in accordance with cGMP with requirements
- Ensures the Quality Management System is implemented, maintained and reviewed in accordance with cGMP regulations
- Alerts senior management of significant quality, compliance, supply and safety risks
- Develops area goals, efficiency projects, and supervises progress
- Accountable for assigned training adherence to permit execution of required tasks
- To be successful, you will require teamwork and partnership cross functionally to ensure the Quality Management System processes are executed in accordance with established procedures
- Strategic advisor to senior management of quality, compliance, supply and safety risks
- Supports internal/external audits and inspections as part of the audit/inspection management team including acting as Quality unit representative as needed
What we expect of you
We are all different, yet we all use our outstanding contributions to serve patients. The Specialist Quality Assurance professional we seek is an individual contributor leader with these qualifications.
Masters degree and 3 years of Quality or Manufacturing experience in GMP regulated environment
Bachelors degree and 5 years of Quality or Manufacturing experience in GMP regulated environment
Beyond that, additional preferred qualifications are:
- Educational background in Life Science or Engineering
- Validated expertise in Quality Systems such as Non Conformance, CAPA, and Change Control
- Experience in electronic systems such as: Maximo, ARMS, Trackwise, LIMS and SAP
- Experience in computer systems validation or computer systems quality assurance (medical device and/or consulting background Technical proficiency)
- Robust knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development
- Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements
- Validated experience as Quality Contact for complex projects involving packaging, inspection, and new products
- Validated experience in Commissioning and Qualification
- Strong organizational skills, including ability to follow assignments through to completion
- Fully Bilingual in English and Spanish
- Enhanced skills in leading, influencing and negotiating
- Demonstrate ability to interact with regulatory agencies
- Proven word processing, presentation, database and spreadsheet application skills
- Strong communication (both written and oral), facilitation and presentation skills
- Validated skill in working independently and to optimally interact with all levels throughout the organization
- Ability to evaluate compliance issues
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Join UsIf 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.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.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.