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.

Position Summary

The Snr. Analyst Incoming Inspection is responsible for coordinating, facilitating, and undertaking activities pertaining to the Incoming Inspection of Components and the testing of Combination Products.

Principal Responsibilities

• Coordinate daily operations and ensure team members are trained in their job function and current revisions of relevant SOPs.
• Sampling of materials for incoming inspection
• Incoming Inspection testing to support release to packaging operations
• Essential Performance Requirements (EPR) testing of Combination Products
• Ensuring high cGMP, GLP standards are maintained while testing and adherence to schedules and targets to meet regulatory and business requirements.
• Completion of project work and implementation of initiatives designed to improve the efficiency of the laboratory function/department.
• Document updates as required
• To keep management updated on issues arising within the Inspection Area/Laboratory.
• Raising SICARs as required and assist in investigations
• Partner closely with planning to ensure priorities are met
• Liaise with vendors as required
• To train personnel and play appropriate role in the development, operation and evaluation of training programs.

Qualifications

• Minimum of 3-5 years of experience in cGMP Quality environment.
• Experience in testing of sterile drug product and aseptic filling process of sterile pharmaceutical /biopharmaceutical products.
• Knowledge of LIMS.
• Knowledge of a Quality Management System e.g. Trackwise.

Education

• Degree in chemistry or biological science with a preference for Analytical Chemistry or Biochemistry
• Experience in a component inspection role would be a distinct advantage.
• Previous hands-on experience in a GMP manufacturing environment is preferred.
• 3-5 years post educational experience with working in a regulated environment preferably within a Pharma/Biotech facility.

• Computer skills (MS Office, MS Excel, MS Project) or comparable word-processing and spreadsheet applications is required.

Competencies

• 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 that of a team
• An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
• Excellent written and oral communication skills.

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.