Amgen QC Manager Microbiology in Dun-Laoghaire-Rathdown, Ireland

This job specification outlines the general responsibilities associated with the role of Manager QC Microbiology on the Amgen Manufacturing site. The site is focused on continuous improvement of all work processes and practices and all colleagues are required to be flexible in this regard. This means that they may be asked to carry out additional work functions that are not described in this specification but are associated with their role.

Specific Job Duties:

  • Overall responsibility for QC In process, Release and Stability testing and the associated test and laboratory documentation.

*Ensure the laboratory is operated in a safe manner

*Develop and maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP

*Compliance with Standard Operating Procedures and Registered specifications.

*Provide an effective and efficient QC service to operations by supervising, developing and coaching the QC team.

*Ensure timely completion of Laboratory Investigation Reports and deviations through the Non-Conformance procedures.

*Issue trend reports on investigations, non conformances and Environmental Monitoring and identify laboratory practices and procedures for further development/improvement.

*Keeps abreast of current Corporate and industry requirements and compliance trends as they pertain to laboratory operations and aseptic manufacturing.

*Approval of SOP's, trend data, investigations, non-conformances, validation protocols, reports, method validation/verifications and equipment qualifications.

*Participate in regulatory agency inspections as required.

*Plan and implement procedures and systems to maximise operating efficiency.

*Manage and contribute to the achievements of department productivity and quality goals.

People Management

*Supervision/Management of laboratory personnel and adjustments to schedules to maximise efficiencies and adequately support production and other departments.

*Conduct performance appraisal reviews for laboratory colleagues and identify training requirements for further development of colleagues.

*Monitor and assist staff with work progress.

Amgen is an equal opportunity employer

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

*Excellent written and verbal communication skills

*Understanding/experience with Trackwise, Change Control Systems, EDMQ and SAP

*Knowledge of applicable Regulatory requirements

*Experience with Regulatory inspections desirable

*Experience leading cross-functional teams desirable

*Experience working with teams and influencing decisions

*Have relevant years of experience in a pharmaceutical/healthcare Laboratory or a related technical function preferably in an Aseptic or microbiologically controlled environment.

*Managerial/Supervisory experience with a proven record in a Supervisor/ Team Lead role.

*Strong background in microbiology and aseptic manufactured is required.

*Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.