30 days old

Specialist Quality Control

Amgen
Juncos, Puerto Rico 00777
  • Job Code
    121423112
Amgen

Job ID: R-101353
Location: Juncos, PR, US 00777

Summary:

Under general direction, functions as the technical specialist for testing and development. Focus is on the sophisticated technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources.

Specific responsibilities include but not are limited to:

  • Responsible for providing technical mentorship
  • Provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise
  • Resolve technical issues and troubleshoot for assays as vital Ensure lab compliance - which includes implementing procedures that improve cGMP, GLP and safety.
  • Lead existing and/or develop and implement new programs, processes and methodologies
  • Develop, revise and audit various sophisticated controlled documents that may have multi-organizational and/or multi-site impact.
  • Approve lab investigations Lead audit teams
  • May serve as subject matter authority to develop technical training.
  • May perform routine work in a specific area of responsibility as vital
  • Represents the department/organization on various teams
  • Independently responsible for following through on multi-site action items.
  • May interact with regulatory agencies regarding area(s) of responsibility including written responses.
  • May resolve issues with outside resources.
  • Performs special projects as requested by supervisor
  • May supervise employees as vital to meet technical requirements


Basic Education and Licenses:

Doctor degree

Or

Master's degree in Science (Engineering, Chemistry, Biology, Mathematics) and 3 years of project management or validation experience

Or

Bachelor's degree in Science (Engineering, Chemistry, Biology, Mathematics) and 5 years of project management or validation experience.

Preferred Qualifications:


  • Understand, support and demonstrate the AMGEN values.


  • Excellent communication skills, facilitation and presentation skills.


  • Excellent technical writing skills.


  • Strong computer operation skills including work processing, presentation, database and spreadsheet application skills.


  • Project management and organizational skills including the ability to independently understand, follow, implement sophisticated instructions and follow assignments through to completion.


  • Skill in prioritizing multiple responsibilities, tasks and projects simultaneously including ability to shift priorities.


  • Excellent knowledge of and experience with processes involved in quality analytical labs, validation, manufacturing, quality assurance, process development and distribution.


  • Knowledge of all testing including the development and validation of assays and the ability to perform all testing in specific area of responsibility.


  • Knowledge of pharmaceutical processes and equipment.


  • Knowledge of U.S. regulations and practices pertaining to the testing of pharmaceutical/biological products.


  • Knowledge of basic international regulations and practices pertaining to the testing of pharmaceutical/biological products.


  • Knowledge and application of cGMPs/CFRs.


  • Knowledge in temperature chambers project implementation requirements.


  • Deep validation experience, including temperature-controlled chambers, sterilization and analytical instrumentation.


  • Ability to evaluate compliance issues.


  • kill in evaluating and detailing according to Company and various guidelines.


  • Proficient at maintenance, troubleshooting and operation of laboratory related equipment, experience with Maximo is a plus.


  • Scientific data analysis and interpretation skills Skills in solving sophisticated problems and support root cause analysis


  • Data trending and evaluation Skill in working independently and to optimal interact with various levels


  • Ability to support regulatory audits and interact with regulatory agencies both orally and in writing Initiate, coordinate and lead cross functional teams



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.



PI121423112

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Posted: 2020-07-08 Expires: 2020-08-08

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Specialist Quality Control

Amgen
Juncos, Puerto Rico 00777

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