What are the responsibilities and job description for the Quality Control Analyst II position at Alexion Pharmaceuticals?
Position Summary
The QC Microbiology Analyst Il will support commercial and clinical manufacturing activities.
This role will ensure compliance in cGMP functions within the QC Microbiology group.
This role will assist in completion of all testing related to raw materials and egg white and additionally support internal activities of QC Microbiology.
Principal Responsibilities
- Follow written procedures for the following tests, bioburden, endotoxin, microbial identification growth promotion
- Support other activities as needed, such as Environmental Monitoring of controlled clean rooms, product qualification s and investigations
- Write and review SOPs, deviations, CAPA, change controls and technical investigations and reports as assigned.
- Recognize aberrant test and sample conditions and report to them to the area supervisor / manager with an assessment of the circumstances and potential corrective action if appropriate.
- Write and compile investigation documentation.
- Maintain knowledge of current scientific principles and theories and train other lab personnel as assigned in areas of competence.
- Order, stock, and receive, labels log and inventory laboratory supplies.
- Provide laboratory support services clean / maintain equipment and prepare reagents / solutions. Perform all job functions in compliance with cGMPs and maintain accurate and legible laboratory records.
- Ensure training is current for all job functions performed. Attend all required Company training.
- Train other lab personnel.
- May be qualified and assigned to review some laboratory data or documentation
Qualifications
Education
BS Degree in Microbiology or equivalent / higher is preferred.
Competencies
Date Posted
07-Feb-2025
Closing Date
03-Apr-2025Alexion 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 Alexion participates in E-Verify.
