Manufacturing Associate
Provide support for development, manufacturing and production operations for regenerative medicine products in a clean room environment.
Main Job Tasks and Responsibilities:
- Process blood-based regenerative medicine products
- Support process development and production of biological products
- Clean and maintain ISO Class 7 clean room
- Perform preventative maintenance to equipment
- Support quality control systems throughout the production and product development processes
- Support qualifications of production equipment
- Perform clean in place and line clearance procedures for routine manufacturing
- Coordinate with R&D/QC for in-process testing and sampling
- Support R&D activities with specific product testing needs
- Recognize and report safety, maintenance, and operational variances
- Communicate status of operations in a timely manner
- Follow detailed operating procedures and batch records
- Ensure compliance with Good Manufacturing Practices and safety requirements
- Maintain files, records, and equipment
- Record data, log activities and monitor processes
- Achieve and maintain proficiency through training
Education and Experience:
- Bachelor of Science or Arts degree from an accredited college / university with a major in biological, chemical, physical, or clinical laboratory science or engineering
- Prefer experience in a hospital, biology, clinical or other regulatory laboratory or in hematology or phlebotomy
Key Competencies:
- Attention to detail
- Hands-on and highly motivated
- Ability to follow written work instructions
- Communication skills - verbal and written
- Ability to work independently and in teams
- Data collection, management, and analysis
Abilities Required:
- Must be able to lift up to 50 pounds
- Ability to stand/sit/walk 8+ hours a day