QC Microbiology Analyst (FTE)

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 individual in this position should have a working knowledge of the cGMP QC laboratory environment and laboratory equipment associated with biopharmaceutical analysis. The position requires the ability to understand and follow written SOPs, to accurately and legibly record work in real time, and pay close attention to detail. The individual must be able to perform routine tasks with a minimum of supervision.

Principal Responsibilities

  • Perform laboratory analytical and microbiological testing including environmental monitoring.
  • Ensuring high cGMP, GLP standards are maintained while testing and adherence to schedules and targets to meet regulatory and business requirements.
  • Validation/Qualification of Microbiology and analytical test methods including HPLC and UV spectroscopy methods.
  • Represent QC department in internal and external audits where appropriate and close out of actions/ recommendations identified from both internal and external audits.
  • Perform technical review of data generated in laboratory, validation protocols and reports. And technical support to Manufacturing and Projects
  • To ensure all instruments/equipment are maintained in a calibrated and operational state.
  • Investigate out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the Laboratory Supervisor, QA and other relevant departments and to implement effective corrective and preventative actions while ensuring all investigations are closed with the specified lead-time.
  • Order, stock and receive laboratory supplies. Provide lab support including reagent preparation, cleaning, and routine equipment maintenance.
  • Ensure training is current for all job functions performed.
  • Receive and manage samples that come into the lab for testing.

Qualifications

  • A working knowledge of the cGMP QC laboratory environment, and equipment associated with testing of biopharmaceutical products
  • Ability to follow written procedures with close attention to detail
  • Ability to function with minimal supervision for routine job duties

Education

  • BSc (Hons) in biosciences with biopharmaceuticals and 3 years’ experience.

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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