Specialist, Incoming QA
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.Live
What you will do
Lets do this! Lets change the world!
In our mission to serve patients, speed is absolutely critical. Were rapidly expanding our hiring initiatives and are excited to unite with the most passionate and forward-thinking scientific minds who want to join our team working toward our mission of advancing high potential programs for cancer patients around the world.
The Incoming Quality Assurance Disposition Manager is responsible for providing Quality oversight to ensure that raw material and component batches are received and evaluated for release according to current Good Manufacturing Practices (cGMP) and other applicable regulations. Responsibilities include:
Quality disposition (release or rejection) of raw materials and components, and Amgen transferred shipments of cell bank, drug substance, drug product, and finished drug product.
Ensures that facilities, equipment, materials, organization, processes, procedures and products align with cGMP and other applicable regulations.
Performs review, approval and tracking of cGMP processes, procedures, assays, documents and records, including but not limited to Nonconformances, CAPAs, and validations.
Supports Continuous Improvement initiatives, programs and projects.
Ensures that changes that could potentially impact product or material quality are assessed according to procedures.
Ensures that deviations from established procedures are investigated and documented per procedures.
Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
Ensures that GMP functions are periodically audited to assess compliance to cGMP regulations and to identify potential risks.
Collaborates cross functionally and across the Amgen Enterprise/Network to ensures the Quality Management System processes are implemented, maintained and executed in accordance with established procedures and applicable regulations.
Alerts senior management of significant quality, compliance, supply and safety risks.
Represents the quality unit during audits and inspections as needed.
Supports internal/external audits and inspections as part of the audit/inspection management team as needed.
Completes required assigned training to permit execution of required tasks.
Performs additional duties as specified by management.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek will have these qualifications.Basic Qualifications:
Masters degree and 3 years of Quality experience
Bachelors degree and 5 years of Quality experience
Associates degree and 10 years of Quality experience
High school diploma / GED and 12 years of Quality experience
Experience with the review and Disposition of batches for all phases of drug development.
Experience with TrackWise for supporting Nonconformance investigations, CAPA, Change Control, Complaints
Experience with cGMP Production Environments
Experience with SAP and Supply Chain concepts
Demonstrated ability with project management, initiating and leading cross-functional teams, and a strong knowledge of and experience with processes involved in manufacturing and distribution, QA, analytical laboratory, validation, and process development
Good understanding of cGMP and regulatory requirements
Experience participating in, managing, and responding to corporate audits/regulatory inspections
Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
Analysis of complex problems and delivery of clear and timely feedback
Strong interpersonal skills
Application of project management principles and techniques
Biology, Chemistry, or Engineering degree is desirable
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
Objects in your future are closer than they appear. Join us.
careers.amgen.com#Operations21Equal 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.