26 days old

Sr. Associate QC - HPLC Laboratory

Amgen
Juncos, Puerto Rico 00777
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  • Job Code
    124087791
Amgen

Job ID: R-105285
Location: Juncos, PR, US 00777

Amgen is looking for multiple experienced Sr. Associate QC, to join the HPLC Drug Substance Laboratory in Quality Operations. The facility highlights the combination of groundbreaking manufacturing sciences and process technology, sophisticated equipment, engineering and automation, and a culture of opportunities integrating cross-functional teams from across the site with the goal of achieving being the best manufacturing facility in the world.

The role

Under general supervision, responsible for one or more of the following activities in Quality Control including analytical testing, approval, characterization, method development, sample and data management.

SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
  • Perform routine laboratory procedures*
  • May perform aliquot ting, sampling and analysis for compendia and non-compendia methods*
  • May perform non-routine laboratory procedures under close supervision*
  • Perform or review one or more of the following: sample testing, standards preparation and testing procedures, compendia and non-compendia test methods, environmental monitoring, reagents and solutions preparation, sample management and equipment maintenance*
  • Prepare complete, accurate, concise laboratory documentation*
  • Data entry, review, analysis, and communication of results*
  • Perform general lab housekeeping
  • Maintain/operate specialized equipment*
  • Participate in the document revision process
  • Align with safety guidelines, cGMPs and other applicable regulatory requirements*
  • Maintain training proficiency*
  • Plan and perform routine analyses with greater efficiency and accuracy*
  • May provide technical guidance
  • Plan and perform multiple, sophisticated routine/ non-routine methods and procedures and a large variety of assays*
  • Report, evaluate, back-up/archive, trend and approve analytical data*
  • Troubleshoot, solve problems, and communicate with stakeholders*
  • Initiate and/or implement changes in controlled documents
  • May train others
  • Participate in audits, initiatives and projects that may be departmental or organizational in scope
  • Write protocols and perform assay validation and equipment qualification/ verification
  • Introduce new techniques to the lab, including method transfers, reports, validations, and protocols*
  • May contribute to regulatory filings
  • May conduct lab investigations
  • Evaluate lab practices for compliance on a continuous basis*
  • Approve lab results*
  • May represent the department/organization on various teams
  • May interact with outside resources


Basic education & experience

Master's Degree

Or

Bachelor's degree or related field & 2 years of experience in a GMP regulated industry

Preferred qualifications
  • Educational background in Chemistry and/or Biochemistry
  • Project management skills
  • Strong organizational skills, including ability to follow assignments through to completion
  • Initiate and lead cross functional teams
  • Enhanced skills in leading, influencing and negotiating
  • Strong Knowledge in Empower System, LIMS, Smart Lab
  • Strong Knowledge and on hand experience in HPLC/UPLC techniques and troubleshooting
  • Collaborate and coordinate with higher level outside resources
  • Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development
  • Demonstrate ability to interact with regulatory agencies
  • Strong word processing, presentation, database, and spreadsheet application skills
  • Strong communication (both written and oral), facilitation and presentation skills
  • Strong skill in working independently and to effectively interact with various levels
  • Advance data trending and evaluation
  • Ability to evaluate compliance issues
  • Demonstrate the Amgen Values/Leadership Practices
  • Strong Knowledge in area of expertise

The benefits

Our broad approach is one of the reasons why we are regularly recognized as a 'Best Place to Work'. We offer a superior benefits package that includes an award-winning retirement and stock plan. And between the paid time off, and wellness program - and on-site childcare and fitness facilities - you will find us focused on your well-being too.

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.



PI124087791
Posted: 2020-09-26 Expires: 2020-10-28

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Sr. Associate QC - HPLC Laboratory

Amgen
Juncos, Puerto Rico 00777

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