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 Supervisor will support the QC department with emphasis on chemistry, and biochemistry. The supervisor will provide technical support with regard to method validation, method transfer, regulatory updates 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.

You will be responsible for:

• Lead a team of analysts in QC by coordinating daily operations and ensuring team members are trained in their job function and current revisions of relevant SOPs
• Ensuring high cGMP, GLP standards are maintained while testing and adherence to schedules and targets to meet regulatory and business requirements,
• Ensure relevant assays are performed on samples in support of release test and stability test programs, including but not limited to: HPLC, UV, iclEF (lmaged Capillary isoelectric focusing), SDS PAGE, Compendia assays
• Support any validation and qualification of test methods and processes
• Lead and participate Quality Risk Assessments relating to QC
• Maintain regulatory compliance through the creation and maintenance of programs for laboratory testing, training, SOPs and validation. Preparation of documentation for audits carried out by internal auditors and Regulatory bodies.
• Facilitate laboratory investigations and support associated product investigation
• Troubleshoot laboratory methods and instrument problems.
• Represent the QC department in internal and external audits where appropriate.
• Close out of actions/ recommendations identified from both internal and external audits.

• Assist in ensuring that current compliance issues and trends, both internal and site-wide, are critically evaluated and training is provided where appropriate.
• 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 while ensuring all investigations are closed with the specified lead-time on TrackWise.

You will need to have:

• B.A / B.Sc or equivalent in Biological Sciences, Chemistry or other biotechnical science or equivalent experience in regulated industry.
• Minimum of 8 years of experience in cGMP Quality environment.
• Proven communication skills including providing communication to higher level management.
• 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.

We would prefer for you to have:

• 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.

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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.