QC Training & Compliance Specialist (12 month fixed term contract)

Alexion Pharmaceuticals
Employment Type
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

Alexion Athlone Quality Control (Microbiology & Chemistry) is a growing department with responsibility for in-process testing and environmental monitoring supporting both Drug Substance and Drug Product manufacture for clinical and commercial products. This position is responsible for oversight of the QC training program and delivery of training to the QC team. The person in this role will also be responsible for developing and implementing improved training processes and training material to ensure that the training provided to the team is effective and comprehensive. In addition, this role is responsible for ensuring QC methods and processes are compliant to compendial and regulatory requirements. This role will also be responsible for ensuring adherence to Quality System processes and procedures and training staff on Quality Systems. In this role, you should have excellent relationship building and problem-solving skills. A high attention to detail and excellent verbal and written communications skills are vital to success in the role.

Principal Responsibilities

  • Oversight of the training program for the QC department including the delivery of training on technical topics to the QC team.
  • Design and maintain a robust onboarding and training program for new starts to the QC team.
  • Develop and deliver technical training as required (e.g. membrane filtration, Endotoxin testing, microbial identification, pH, conductivity, plate reading, environmental monitoring, utilities monitoring, HPLC, UV)
  • Identify, lead and implement continuous improvement initiatives which ensure maintenance of cGLP, inspection readiness, data integrity and eliminate/reduce risk
  • Support the introduction of new methods/techniques/technologies into the QC Microbiology laboratory and ensure compliance of existing methods/processes to compendial and regulatory requirements
  • Manage the continuous improvement program for QC including planning and facilitating workshops and supporting the translation of the output to procedural/process updates.
  • Documentation flow and paperwork practices – Improving Right First Time and reducing GDP errors within QC and implementing processes to track and trend performance against targets
  • Support investigation of major laboratory investigations, identifying and implementing robust CAPA’s to prevent recurrence
  • Develop simplified and effective scheduling for training activities to maximise available resources
  • Generation of QC metrics and presentation of metrics to QC management on a monthly basis
  • Actively participate in and support inspection readiness for the QC Department acting as SME as required
  • Present and report on project progress and continuous improvement to QC management on a monthly basis
  • Maintain regular and proactive communication with all stakeholders.

Education & Experience

  • At least 5 years’ working in a GMP Quality Control Laboratory
  • BSc./MSc. Degree in science/pharmaceutical related subject (preferably Microbiology)
  • Knowledge and understanding of GMP/GDP standards
  • Strong problem solving and leadership experience
  • Experience in workshop facilitation
  • Experienced in leading and executing continuous improvement initiatives
  • Experience of SOP authoring and document management processes
  • Highly Computer literate, with MS Office (Word, Excel)
  • Experience of provision training to others
  • Good working knowledge of QC Microbiology and lab practices and troubleshooting
  • Knowledge and experience with Chemistry instrumentation and methods is beneficial but not essential
  • An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
  • Excellent communication & presentation skills are essential.
  • Excellent time management organizational skills along with a proven ability to multi-task.

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.