EWH Technician II - Bogart, GA - Alexion Pharmaceuticals

Description

Egg White Harvest Technician II

The Egg White Harvest 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

1. Egg white harvest according to established Standard Operational Procedures (SOP's) in accordance with current Good Manufacturing Practices (cGMP).
2. Execution of Master Batch Records (MBR's) in accordance with Good Documentation Practices (GDP).
3. Aseptic manipulations within a laminar flow room according to established Standard Operating Procedures (SOP's).
4. Equipment operation (EM and manufacturing)
5. Inventory control
6. Accountability to individual and team safety policies and procedures.
7. Completion of cGMP documentation according to approved procedures
8. Process sampling
9. Ability to withstand -20C temperature exposure with appropriate Personal Protective Equipment (PPE)
10. Cleaning and sanitization of equipment
11. General housekeeping of manufacturing area
12. Leads EW shipping and the receiving of EWH materials
13. Performs hands on training for new EWH technicians
14. Maintains EWH and EM databases
15. Revises EWH procedures and forms
16. Provides first drafts of Deviations, OOS, or CAPAs for EWH activities.
17. 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

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

Alexion Pharmaceuticals