Amgen

Specialist QA

Employer
Amgen
Location
Thousand Oaks, CA
Posted
Sep 27, 2021
Ref
R-126970
Required Education
High School or equivalent
Position Type
Full time

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!

The Quality Assurance Site Support and Disposition Specialist is responsible for providing Quality oversight to ensure that clinical and/or licensed pharmaceutical products are manufactured, tested, dispositioned, and stored according to current Good Manufacturing Practices (cGMP) and other applicable regulations. Specific responsibilities may include:

  • Ensures that facilities, equipment, materials, organization, processes, procedures and products align with cGMP practices and other applicable regulations.

  • Performs review, approval and tracking of cGMP processes, procedures, assays, documents and records, including but not limited to SOPs, Deviation investigations, CAPAs, and Validation protocols and reports.

  • Supports Continual Improvement initiatives, programs and projects.

  • Ensures that changes that could potentially impact product quality are assessed according to 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, including possible Quality disposition (approval or rejection) of manufacturing batches of cell bank, bulk drug substance, bulk drug product, and finished drug product

Win

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

Doctorate Degree

OR

Master's Degree & 3 years of cGMP experience

OR

Bachelor's Degree & 5 years of cGMP experience

OR

Associate's degree & 10 years of cGMP experience

OR

High school diploma/GED & 12 years of cGMP experience

Preferred Qualifications:
  • Experience with the review and Disposition of batches for all phases of drug development.

  • Experience with TrackWise for supporting documentation of Deviation investigations, CAPAs, and Change Control records

  • 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 cGMPs 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

Thrive

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

Apply now for a career that defies imagination

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.

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


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.

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.