28 days old

Specialist Quality Assurance

Amgen
West Greenwich, RI 02817
  • Job Code
    124150217
Amgen

Job ID: R-105145
Location: West Greenwich, RI, US 02817

The Quality Assurance Specialist will be responsible for On The Floor (primary role) and Off The Floor activities for Quality Assurance 1st Shift (Tuesday through Friday 6am - 4pm). This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations. The role has the ability to foster a strong partnership and learning environment between Manufacturing and Quality staff. Amgen's Quality Assurance Shift 1 provides coaching, guidance and direction to Manufacturing, Quality Control, Supply Chain and Facilities & Engineering staff in regard to compliance and quality systems responsibilities include the following:
  • Responsible for providing Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing.
  • Practices (cGMP), Good Distribution Practices (GDP).
  • Ensures that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations.
  • Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Nonconformance, Corrective Action/Preventative Actions (CAPA), Change Control records and validations, Raw Materials and Drug Substance documentation.
  • Author/review/approve quality documents, such as: SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, environmental qualification protocols/reports, validation protocols/reports.
  • Establish and enable LEAN practices.
  • Oversee and provide guidance during on-the-floor analytical testing.
  • Ensures that changes that could potentially impact product quality are assessed according to procedures.
  • Ensures that deviations from established procedures are investigated and documented per procedures.
  • Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
  • Alerts senior management of quality, compliance, supply and safety risks.
  • Drive operational improvement initiatives, programs and projects.


Basic Qualifications
  • Doctorate degree
  • OR
  • Master's degree and 3 years of Quality, Manufacturing, Process Development or Process Engineering experience
  • OR
  • Bachelor's degree and 5 years of Quality, Manufacturing, Process Development or Process Engineering experience
  • OR
  • Associate's degree and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience
  • OR
  • High school diploma / GED and 12 years of Quality, Manufacturing, Process Development or Process Engineering experience


Preferred Qualifications
  • Scientific degree in Life Sciences or Physical Sciences or Applied Engineering or Manufacturing Technologies
  • Previous QA oversight of manufacturing, analytical and engineering activities
  • Experience in investigations, change controls, and CAPAs processes system knowledge
  • Experience and training in EDMQ, Trackwise, Maximo, LIMS
  • Experience in managing multiple, competing priorities in a fast-paced environment
  • Experience leading and/or managing teams
  • Direct bulk drug substance and drug product experience
  • Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff.
  • Ability to solve make scientific risk-based decisions
  • Experience representing Amgen while interacting with representatives of regulatory agencies
  • Experience of trending analysis
  • Demonstrated proficiency using Excel, Word and Power Point


Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages 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.

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: 2020-09-29 Expires: 2020-10-30

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Specialist Quality Assurance

Amgen
West Greenwich, RI 02817

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