Amgen

Specialist Quality Assurance - AML 14 Drug Product Support

Employer
Amgen
Location
Juncos, PR, US
Posted
Oct 30, 2020
Ref
R-107284
Required Education
Bachelors Degree
Position Type
Full time
Are you a Quality professional with vast knowledge in Operations and drug product aseptic manufacturing processes?

Amgen is looking for multiple experienced Specialist QA professionals with the availability to support a nonstandard work schedule for our Amgen Manufacturing Limited (AML) operation in Puerto Rico. As Specialist QA, you will bring forth out of the box thinking, an agile mindset and proven subject matter expertise with innate understanding of Quality processes and controls in support of our AML-14 large-scale 24/7 manufacturing plant.

The AML-14 facility is the home of world-class multi-product drug product Manufacturing Operations. The facility highlights the combination of cutting-edge manufacturing sciences and process technology, advanced equipment engineering and automation, and a dynamic culture integrating cross-functional teams from across the site with the goal of being the best sterile biological drug product manufacturing facility in the world.

Through superior Quality oversight on-the-floor operations, you will be responsible for ensuring that pharmaceutical products are manufactured, tested, stored, and distributed according to cGMP practices and other applicable regulations. In addition, you will be responsible for ensuring facilities, equipment, materials, processes, and procedures adhere to cGMP and other regulatory requirements and remain in a state of inspection readiness.

SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
  • Provide on-the-floor support to Manufacturing operations and represent the Quality organization
  • Perform review, audit, and approval of manufacturing batch records and protocols to ensure production records are complete, accurate, and documented according to written procedures and cGMP requirements
  • Actively engage in Continuous Improvement initiatives, programs and projects and develop solutions that are thorough, practical and consistent with functional objectives
  • Review and approve GMP documents and deviations as the Quality representative
  • Certify that deviations from established procedures are investigated and documented per procedures
  • Vigilantly ensure that changes that could potentially impact product quality are assessed according to procedures
  • Apply analytical skills to evaluate and interpret complex situations and problems using multiple sources of information to anticipate and prevent potential problems
  • 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
  • Accountable for assigned training adherence to permit execution of applicable tasks
  • Champion Continuous Improvement initiatives and projects
  • Support multidisciplinary initiatives and projects as manager back-up when needed


BASIC QUALIFICATION/EDUCATION

Doctor degree

Or

Master's degree and 3 years of Quality or Manufacturing experience in GMP regulated environment

Or

Bachelor's degree and 5 years of Quality or Manufacturing experience in GMP regulated environment

ADDITIONAL PREFERRED QUALIFICATIONS ARE:
  • Educational background in Life Science, Engineering or Computer Science
  • Experience in on-the-floor support to production and manufacturing operations
  • Expertise in Quality Systems such as Non Conformance, CAPA and Change Control
  • Robust knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, and Process Development
  • Exposure to 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
  • 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
  • Demonstrate ability to interact with regulatory agencies
  • Solid word processing, presentation, database and spreadsheet application skills
  • Strong communication (both written and oral), facilitation and presentation skills
  • 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


As Specialist Quality Assurance you will be unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering creative 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.

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 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.

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.