Senior Associate Quality Control Support

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.

Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Be part of Amgens newest and most advanced drug substance manufacturing plant. When completed the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities but it will also integrate sustainability innovations to reduce carbon and waste as part of Amgens plan to be a carbon-neutral company by 2027.

Senior Associate Quality Control Support

What you will do

Lets do this. Lets change the world. In this vital role you will be responsible for supporting the site QC systems team. Responsibilities will include owning and authoring change controls and investigation records to support initial lab equipment installation qualification and validation implementation of computerized systems and establishment of the QC GMP processes and then transition to routine record ownership. The Senior Associate QC Systems will report directly to the Director of Quality Control.

Under minimal direction the successful candidate will support the startup of the QC organization by:

• Working collaboratively with Quality and Quality Assurance teams to author and own change records and deviations
• Individual will lead investigation teams and help to collect and report metrics for the systems team
• Individual may assist with review of validation documents to support equipment and computerized system onboarding.
• Individual may author revise and review documents and reports including but not limited to SOPs test methods safety assessments trend reports qualification/validation summary reports technical reports.
• Support the startup of a GMP QC laboratory.
• Participate in audits initiatives and projects that may be interdepartmental or global in scope.
• Support routine activities over the weekends and public holidays as required.

What we expect of you

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

Basic Qualifications:

• High School/GED 4 years of Quality work experience OR
• Associates 2 years of Quality work experience OR
• Bachelors 6 months of Quality work experience OR
• Masters

Preferred Qualifications:

• Degree in a related scientific field such as Chemistry Microbiology Molecular Biology Physics or Engineering.
• 3-5 years of relevant laboratory experience in the GMP commercial manufacturing environment within the pharmaceutical or biopharmaceutical industry and analytical testing experience preferred.
• Solid understanding of aseptic technique.
• Proficient in the use of Veeva and Trackwise systems
• Experience in a lead role providing guidance to team members.
• Knowledge of related regulatory/industry considerations compliance issues and/or scientific discovery.
• Strong written and verbal communication skills including technical writing and presentation.
• Familiar with authoring or owning change control records.
• Experience with equipment and method validation verification and transfer including the change control process.
• Interact effectively with variety of communication and working styles and ability to work well in teams.

What you can expect of us

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.

In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.

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 and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

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 disability status or any other basis protected by applicable law.

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.

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