Job Description:
Position Summary
The Egg White Harvest Technician II (EWH Technician II) will perform all daily EWH activities including harvests, environmental monitoring, sampling, line clearances, and documentation; follow standard operating procedures and good documentation practices; organize, clean, and maintain harvest suite, supplies, and equipment. The EWH Technician II will support the production facility by working shifts, weekends, and holidays as needed.
Principal Responsibilities
- Egg white harvest according to established Standard Operational Procedures (SOP's) in accordance with current Good Manufacturing Practices (cGMP).
- Execution of Master Batch Records (MBR's) in accordance with Good Documentation Practices (GDP).
- Aseptic manipulations within a laminar flow room according to established Standard Operating Procedures (SOP's).
- Equipment operation (EM and manufacturing)
- Inventory control
- Accountability to individual and team safety policies and procedures.
- Completion of cGMP documentation according to approved procedures
- Process sampling
- Ability to withstand -20C temperature exposure with appropriate Personal Protective Equipment (PPE)
- Cleaning and sanitization of equipment
- General housekeeping of manufacturing area
- Leads EW shipping and the receiving of EWH materials
- Performs hands on training for new EWH technicians
- Maintains EWH and EM databases
- Revises EWH procedures and forms
- Provides first drafts of Deviations, OOS, or CAPAs for EWH activities.
- Leads team in absence of Supervisor/lead
Qualifications
- Excellent verbal and written communication skills.
- Experience with inventory control methods and electronic inventory systems preferred.
- Proficiency in Outlook, Word and Excel and knowledge of PC spreadsheets required.
- Experience in a GMP manufacturing environment required.
Education
- High School Diploma plus 2 years' experience in cleanroom or GMP environment
- BS, AS, or Certificate plus 1 years' experience in cleanroom or GMP environment
Date Posted
03-Dec-2024
Closing Date
09-Dec-2024Alexion 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 requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
