21 days old

Sr Associate Quality Control

Amgen
Juncos, Puerto Rico 00777
  • Job Code
    121655668
Amgen

Job ID: R-101771
Location: Juncos, PR, US 00777

Summary:

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

Specific responsibilities include but are not limited to:

  • Perform routine laboratory procedures
  • May perform aseptic aliquoting, sampling and analysis for compendia and non-compendia methods
  • May perform non-routine lab 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 mentorship
  • 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, seek problems and connect with partners
  • Initiate and/or implement changes in controlled documents
  • May train others as needed
  • 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 as needed and identify areas of improvement to avoid recurrences
  • May act as owner, reviewer or data verifier in technical documents, including investigations*
  • May support root cause analysis and interviews
  • May be the owner of records in electronic systems
  • 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


Knowledge:

  • Understanding and application of principles, concepts, theories and standards of technical/scientific field
  • Specialized knowledge within own specialty area
  • Deepens technical knowledge through exposure and continuous learning
  • Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery


Problem Solving:

  • Applies research, information gathering, analytical and interpretation skills to problems of diverse scope
  • Ensures compliance within regulatory environment
  • Develops solutions to technical problems of moderate complexity
  • Screens, categorizes, evaluates, reconciles, reports and resolves data integrity issues
  • Interprets generally defined practices and methods


Autonomy:

  • Works under general direction
  • Work is guided by objectives of the department or assignment
  • Refers to technical standards, principles, theories and precedents as needed
  • May set project timeframes and priorities based on project objectives and ongoing assignments
  • Recognizes and raises problems


Contribution:

  • Contributes to work group/team by ensuring the quality of the tasks/services provided by self
  • Contributes to the completion of achievements associated with specific projects or activities within own department or workgroup
  • Provides training/mentorship to others and acts as a technical/scientific resource within work group/team
  • Establishes working collaborations outside area of expertise


Basic Education & Experience:

Bachelor's degree or related field & 2 years of Quality Control experience or Analytical Laboratory.

Or

Master's degree

Preferred qualifications:

  • Educational background in Life Sciences
  • Project management skills
  • Technical writing 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
  • Proven understanding in area of expertise
  • Collaborate and coordinate with higher level outside resources
  • Proven understanding 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 efficient interact with various levels
  • Advance data trending and evaluation
  • Ability to evaluate compliance issues
  • Demonstrate the Amgen Values/Leadership Practice


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.



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Posted: 2020-07-17 Expires: 2020-08-17

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Sr Associate Quality Control

Amgen
Juncos, Puerto Rico 00777

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