Some opportunities happen only once in a lifetime - like a job where you have the chance to 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 Microbiology Shift lead specialist will support the QC department with emphasis on QC Microbiology. The Shift Lead specialist will provide technical support with regard to method verification, Environmental Monitoring, Cleaning Validation Utilities and new technology. They will oversee the operation of a QC testing group for out of hours or on weekends where the supervisor is not available by means of a hands-on approach to laboratory operations.

You will be responsible for:

• Where the supervisor/manager is not available - Lead a team of analysts in QC by coordinating daily operations and ensuring tasks are complete to meet business needs.
• Where the supervisor/manager is not available - Support the initiation of LIR’s concerning time sensitive samples for critical out of hours/weekend repeat tests

• Where the supervisor/manager is not available – Represent the microbiology department during out of hours/weekends
• Where the supervisor/manager is not available – Team point of contact for decision making
• To keep the QC microbiology supervisors/management updated on issues arising within the laboratory and perform appropriate and accurate handovers for the shift teams.
• To report to and be directed by the QC microbiology supervisors and to organize and schedule the smooth running of the micro laboratory in the absence of the micro supervisor.
• Facilitate laboratory investigations and support associated investigation

• Support validation/verification and qualification of test methods and processes.
• Troubleshoot laboratory methods and instrument issues as they arise.
• Completion of project work and implementation of initiatives designed to improve the efficiency of the laboratory function/department.
• Lead and participate in Quality Risk Assessments relating to QC.
• Technical report writing in support of routine testing, method verifications and Trackwise reports.

• Perform technical review of data generated in laboratory, validation protocols and reports.
• Represent the QC department in internal and external audits where appropriate.

You will need to have:

• Minimum of 4 years of experience in cGMP Quality environment.
• Experience in leading teams preferred but not essential preferential
• Experience in critical decision making
• Excellent time management and experience in scheduling of lab priorities for a team
• 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.
• Degree in Science/ Microbiology or related science.
• 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:

• 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 ability to delegate tasks where appropriate.
• Excellent written and oral communication skills.
• Ability to develop collaborative relationships with other functions and sites in order to achieve functional, site and company goals.

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Alexion is 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. Further information about Alexion can be found at: www.alexion.com.

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 lack thereof, sex, sexual orientation, 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 an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. 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, click here.