Amgen

Specialist QA (Environmental Control Program)

Employer
Amgen
Location
Juncos, PR
Posted
Jul 04, 2021
Ref
R-115031
Required Education
Bachelors Degree
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.

Specialist QA

Live

What you will do

This Specialist QA role is aimed to provide expert technical support, quality leadership and compliance guidance in the on-time resolution and effective management of routine and non-routine Environmental Monitoring (EM) and Contamination Control related matters across AML. This includes continuous oversight to ongoing EM programs to manufacturing classified areas and critical utility systems as well as to the rest of the site GMP and non GMP operational areas. As a subject matter expert (SME) position within the site Quality Operations team, this role is also intended to provide expert technical advice and direction along to the site efforts to address complex operational deviations with potential impact to product quality. As Specialist QA within the Environmental Control Team (ECP), you will be appointed as the site primary contact and liaison to the Amgen Contamination Control network and will speak before regulatory agencies on related matters.

RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
  • Provide routine ownership and leadership in the sustainability of the AML Environmental Monitoring program related to classified areas and critical utility systems.
  • Responsible to provide expert quality and technical support in the resolution of complex contamination control related investigations.
  • Responsible to review environmental monitoring data and trend reports including expert interpretation of raw data from primary sources.
  • Responsible to provide EM subject matter expertise across the site during troubleshooting events and presenting the EM program performance during audits and inspections.
  • Provide guidance in the acceptability of gowning outfits and consumable manufacturing materials including the establishment of the necessary requirements to implement such materials within the site GMP operational areas.
  • Support the specification and design of garments to be used in aseptic and clean room environments.
  • Support the design and implementation of routine procedural controls and sampling strategies to effectively monitor the performance of critical classified manufacturing processing areas.
  • Develop the required justifications and scientific postures for the selection of sampling locations within production and engineering systems intended for contamination control.
  • Responsible for the execution of risk assessments in support to the sustainability of the overall site Environmental Monitoring programs.
  • Ensure site alignment with Amgen Contamination Control network multisite procedures, standard practices and applicable regulations for consistency and to maintain required state of compliance.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a leader with these qualifications.

PhD

or

Masters degree and 3 years of Quality experience in pharmaceutical, medical device or biotechnology industry

or

Bachelors degree & 5 years of Quality experience in pharmaceutical, medical device or biotechnology industry

Beyond that, additional preferred qualifications are:
  • Educational background in Microbiology, Industrial Microbiology, Environmental Science
  • Experience working on GMP regulatory and compliance manufacturing environments with a strong Quality mindset in the production of sterile biological products.
  • Experience conducting trending, monitoring an oversight of cleaned, controlled and classified environments for sterile and non-sterile manufacturing areas.
  • Proficient establishing environmental control procedures and assessing adequate gowning systems to personnel interacting within controlled environments.
  • Capable to troubleshoot contamination events, determine action plans and propose compliant solutions to address complex contamination control problems.
  • Proficient in the development of expert protocols aimed to mitigate quality and operational contamination events across AML (e.g. cleaning and sanitation procedures, disinfectants implementation and qualification, microbiological samplings and techniques for adequate contamination control prevention).
  • Capable of solving problems related to microbial growth within industrial pharmaceutical controlled environments.
  • Apply statistical tools and methodologies in the process of conducting environmental control trending and monitoring analysis.
  • Capable to conduct scientific data gathering, analysis, interpretation and reporting of expert technical documents intended to diagnose the state of microbiological control of facilities and critical utilities (e.g. water for injection)
  • Project Management Skills.
  • Presentation Skills.
  • Information/Computer Systems knowledgeable.
  • Excellent interaction skills to enable appropriate performance supporting complex matrix organizations.

Thrive

What you can expect of us

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.

  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

#Operations21


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.