QC Senior Specialist, Equipment

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.

This is what you will do:

The QC Senior Specialist, Equipment primary focus will be supporting all qualification activites associated with the installation, qualification and ongoing support of the validated state of laboratory equipment in the cGMP Laboratories at ADMF.

This individual will be a high functioning, highly adaptable resource for the Laboratory Support Equipment team and will conduct qualification activites in alignment with site SOPs and regulatory standards for laboratory equipment qualification and maintenance.

You will be responsible for:

  • Evaluating laboratory equipment in accordance with CGMPs, Part 11 and other regulatory requirements
  • Working closely with user groups to evaluate, develop, implement and maintain laboratory equipment and systems
  • Planning, executing and documenting the qualification of new or upgraded laboratory equipmnet in a cGMP regulatory environment
  • Developing and or writing all required validaton documentaiton or reports
  • Generation and resolution of protocol deviations and descrepancies as required
  • Accompanying vendors (as requried) to ensure all documenation generated as part of installation/qualification or routine calibration/requalification is completed in a complant manner

You will need to have:

  • Subject Matter expert in CSV for Computirised System Validation
  • In depth knowledge of Annex 11 and CFR Part 11 requriements
  • In depth knowledge and understanding of current regulatory requirements for cGMP laboratory equipment validation
  • Experienced in the execution of validation, data management and data integrity activities
  • The duties of this role are generally conducted in an lab environment. As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted; work comfortably in a controlled environment with and around biological, infectious, and hazardous materials; gown/degown PPE; use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

  • A minimum of 5 years experience in a similar role
  • A degree in chemistry, software or an engineering related discipline
  • Excellent technical competancy in relation to instrumentation and equipment validation
  • Skilled in organising, planning and priority setting along with strong time management skills
  • Works very well in a collaborative manner
  • Takes a structured, analytical approach to problem solving.

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,parental status (including adoption or surrogacy), pregnancy(including childbirth, breastfeeding, or related medical conditions), 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.

null