The Manufacturing Associate role works as part of the manufacturing team to deliver high quality therapeutics. This role is focused on processing of cell therapy technologies where Aseptic Processing is of the utmost importance.
Requirements
- Performs Aseptic operations in a Grade A environment
- Supports production in an aseptic environment
- Executes on production batch records and work orders according to SOPs and protocols
- Generates work orders
- Assists in all areas of cell therapy and all related duties as required
- Assists in manufacturing batch record review
- Participates in root cause investigations and CAPA
- Drafts and revises SOPs/ WINs/ BRs
- Executes SAP transactions
- Executes media batching
- Routine maintenance and cleaning of rooms and equipment
- Identifies and implements continuous improvements
- Adheres to all safety protocols and procedures
- Executes visual inspection of final drug product
- Manages D space during production
- Assists the team with maintaining an up-to-date working inventory for the equipment/supplies
- Documents and reviews appropriate paperwork, daily logs, and documentation per Good Documentation Practices
- Participates in a detailed training program and develops training plan
- Maintains inventory of equipment and supplies
- Identifies and implements continuous improvements
- Performs tasks in a manner consistent with the safety policies, quality systems, and GMP requirements
Benefits
- Medical, Dental, Vision
- Life Insurance
- 401k
- Paid Time Off
