27 days old

Senior Associate Plant Quality Assurance

Amgen
Woburn, MA 01801
  • Job Code
    121423207
Amgen

Job ID: R-101433
Location: Woburn, MA, US 01806

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.

As part of the Amgen's Manufacturing Operations organization, our Amgen Woburn Manufacturing (AWM) site manufactures oncolytic virus based end-to-end drug substance and drug products for the global market. As such we continuously strive to be a leader in detailed execution to ensure we deliver our medicines to every patient, every time. Operational Excellence is at the core of how we do what we do with a continuous improvement approach, and a steadfast focus on safety, quality, and compliance.

The Sr. Associate will be accountable for Quality On the Floor in support of Manufacturing activities. This position provides the opportunity to work directly with Manufacturing staff during operations to facilitate real-time decision-making regarding quality requirements and deviations. This is a unique opportunity to foster a positive relationship and learning environment between Manufacturing and Quality staff. Amgen's Quality Assurance On-the-Floor provides mentoring, guidance and direction to Manufacturing, Quality Control and Facilities & Engineering staff in regards to compliance and quality systems.

Responsibilities:
  • Responsible for providing Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing
  • Practices (cGMP), Good Documentation Practices (GDP) and other applicable regulations
  • 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 Standard Operating Procedures (SOP), Batch Records, Nonconformance, Corrective Action/Preventative Actions (CAPA)
  • 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
  • Coordinate and provide guidance during on-the-floor analytical testing
  • Ensures that deviations from established procedures are investigated and documented per procedures
  • Ensures that production records and testing results are complete, accurate, and recorded according to written procedures and cGMP requirements
  • Alerts senior management of quality, compliance, supply and safety risks
  • Achieves required assigned training to permit completion of required tasks
  • Drive operational improvement initiatives, programs and projects.


Basic Qualifications:

Master's degree

OR

Bachelor's degree and 2 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience

OR

Associate's degree and 6 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience

OR

High school diploma / GED and 8 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience

Preferred Qualifications:
  • Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies
  • Previous QA oversight of manufacturing, analytical and engineering activities
  • Experience in investigations, change controls, and CAPAs processes system knowledge
  • Direct Validation experience with pharmaceutical or biopharmaceutical processes
  • Ability to evaluate compliance issues and interact with regulatory inspectors
  • Experience and training in EDMQ, Trackwise, Maximo, LIMS
  • Experience in handling multiple, competing priorities in a fast-paced environment
  • 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 complex problems and 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


We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.

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.

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

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Senior Associate Plant Quality Assurance

Amgen
Woburn, MA 01801

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