Sr Associate QC

1 month ago

Dublin, Ireland Amgen Full time

Job Summary: QC CAS - Sr Associate

Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing of EU Release, Commercial, Stability, Utilities, raw materials and Validation.

  • 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

Extended hours and weekend work flexibility may be necessary as required. Please note this is a Fixed Term Contract (FTC) for 12 months.

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Specific Job Duties:

  • Plan and perform analyses with great 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.

  • Review protocols and perform assay validation and equipment qualification/ verifications when required.

  • Introduce new techniques to the lab, including method transfers, reports, validations and protocols.

  • May contribute to regulatory filings.

  • May conduct lab investigations as necessary.

  • Evaluate lab practices for compliance on a continuous basis.

  • Approve lab results.

  • May interact with outside resources.

  • LIMS data coordination of commercial and import testing on site where applicable

  • May represent the department/organization on various teams. May train others.

Primary Knowledge, Skills, Competencies and Relevant Experience

Knowledge:

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

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

Skills:

  • Communication skills (verbal and written) at all levels

  • 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

  • Investigation 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

Competencies:

  • 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

  • Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleagues

  • Auditing documentation and operation process

  • Demonstrated ability to interact with regulatory agencies

Relevant experience:

  • Bachelor’s degree in a Science related field is required.

  • 4+ 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.

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