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Amgen Sr Associate Quality Control - 24/5 Shift in Dun Laoghaire, Ireland

Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterization, method development, sample and data management and equipment maintenance.

• Contributes to team by ensuring the quality of the tasks/services provided by self

• Contributes to the completion of milestones associated with specific projects or activities within team

This role will support manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required.

Specific Job Duties:

• With a high degree of technical flexibility, work across diverse areas within the lab

• Plan and perform routine analyses with efficiency and accuracy.

• Plan and perform multiple, complex 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.

• 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.

• Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.

• Approve lab results

• May participate in lab investigations.

• May provide technical guidance.

• May train others.

• May contribute to regulatory filings.

• May represent the department/organization on various teams

• May interact with outside resources.

Basic Qualifications:

• Bachelor’s degree in a science discipline.

• 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.

• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

Preferred Qualifications:

• Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning

• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery

• Experience in a wide variety of analytical techniques including but not limited to Capillary Electrophoresis, Gels or HPLC.

Skills:

• Take initiative to identify and drive improvements

• Excellent verbal and written communication skills

. Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)

. Presentation skills

. Escalate issues professionally and on a timely basis

• Decision Making skills

• Teamwork and Coaching others

• Negotiation and Influence skills

• Problem solving skills

. 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

. Able to use statistical analysis tools to perform data trending and evaluation

• Project Management and organizational skills, including ability to follow assignments through to completion

Compentencies:

• Demonstrated ability to work independently and deliver right first time results

. Works under minimal direction

. Work is guided by objectives of the department or assignment

. Follows procedures

. 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 escalates problems

• Demonstrated leadership and communication skills

• Auditing documentation and operation process

• Demonstrated ability to interact with regulatory agencies

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.

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