QC Supervisor

Recruiter
Alexion Pharmaceuticals
Employment Type
Permanent
Salary
Not disclosed
Alexion Pharmaceuticals logo

Some opportunities happen only once in a lifetime – like a job where you have the chanceto change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.

Position Summary

The QC Microbiology Supervisor will support the QC department with emphasis on QC Microbiology. The supervisor will provide technical support with regard to method verification, Environmental Monitoring, Utilities and new technology. They will oversee the operation of a QC testing group by means of a hands on approach to laboratory operations.

The QC Supervisor will supervise a team of analysts and be responsible for all aspects of people management including training, time management and performance reviews. This role will be responsible as an SME on product testing and environmental monitoring with responsibility for deviation writing, technical writing and schedule management for the shift team in Athlone.

Principal Responsibilities

  • Lead a team of analysts in QC by coordinating daily operations and ensuring tasks are complete to meet business needs.
  • Ensuring high cGMP, GLP standards are maintained while testing.
  • Support validation/verification and qualification of test methods and processes.
  • Support equipment qualification as required.
  • Lead and participate Quality Risk Assessments relating to QC.
  • Facilitate laboratory investigations and support associated product investigation
  • Troubleshoot laboratory methods and instrument problems.
  • Perform technical review of data generated in laboratory, validation protocols and reports.
  • Completion of project work and implementation of initiatives designed to improve the efficiency of the laboratory function/department.
  • To ensure a high standard of housekeeping is maintained in the Laboratory.
  • To keep management updated on issues arising within the laboratory.
  • To ensure all instruments/equipment are maintained in a calibrated and operational state.
  • Represent the QC department in internal and external audits where appropriate.
  • To maintain competence and keep up to date with all new technologies, procedures and methods used in the QC Laboratories.
  • Collaborate with the QC System Specialist to develop and implement LIMS for the Microbiology Laboratory.
  • Investigate out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the QC Manager, QA and other relevant departments and to implement effective corrective and preventative actions.
  • Scheduling of testing, review and authorization of microbial data.
  • To represent the Microbiology laboratory at internal and external meetings in the absence of the Laboratory Manager.
  • Time management and performance feedback for direct reports.

Qualifications

  • Minimum of 7 years of experience in cGMP Quality environment.
  • Experience in managing/leading teams preferential.
  • Experience in testing of sterile drug product and aseptic filling process of sterile pharmaceutical /biopharmaceutical products.
  • Good knowledge of current regulatory requirements for QC / Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing.
  • Experience in Quality Risk Management.
  • Excellent knowledge of LIMS.

Education

  • Degree in Science/ Microbiology or related science.

Competencies

  • A high degree of technical competency.
  • Ability to develop collaborative relationships with other functions and sites in order to achieve functional, site and company goals.
  • Excellent problem solving and root cause analysis skills.
  • Routinely takes an innovative approach in developing processes and procedures that are both efficient and compliant.
  • Strong organizational skills.
  • Planning/scheduling of own work and subordinates and ability to delegate tasks where appropriate.
  • Excellent written and oral communication skills.
  • Knowledge of LIMS.

Alexionis a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Furtherinformation about Alexion can be .

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lackthereof, sex, sexualorientation, age, ancestry, national origin, ethnicity, citizenship status, marital status,pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin aninteractive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.

AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you’re interested in career opportunities with AstraZeneca, clickhere.

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