The Department of Manufacturing Support is responsible for maintaining an uninterrupted supply of materials essential for the functioning of the site.
This position is responsible for stocking material and equipment sanitization within classified areas to support manufacture of commercial cell therapy products.
Key responsibilities include:
- Performs manufacturing support procedures in accordance to established SOPs, cGMPs, and safety regulations in classified areas.
- Restocks and distributes material into classified areas in accordance with specific material requirements.
- Open cartons and transfers material stock onto racks, bins, shelves and refrigerators in classified cleanroom areas.
- Performs equipment sanitization activities within clean room environment.
- Documents and reviews operations performed on equipment sanitation in log sheets according to cGMPs and established Standard Operating Procedures.
- General housekeeping of manufacturing controlled area.
- Collects and submits manufactured samples for QC testing
- Maintains LN2 and CO2 systems including manual fills of Liquid Nitrogen Cryovials Storage Dewars weekly.
- Assists in preparation of inventory sales order fulfillment process and end of day closing activities.
- Records equipment metrology readings to ensure the equipment/Facility is operating within specifications.
- Removal of Sharp containers and disposal of liquid Biohazard waste from classified areas.
- Assists in preparation of Vericel Biopsy Kit assemblies.
- Assists in Biopsy Accessioning activities (Receipt and Inspection) processes.
- May assist and participate in scheduled annual physical inventory activities.
- Assists in providing on the job training to employees.
- Performs additional activities as required to support manufacturing operation demands and department coverage.
Qualifications, Education and Experience:
- GED, High school diploma or equivalent with a minimum of 1 year of experience working in a cGMP environment in the biotech or pharmaceutical industry.
- Ability to comply with regulatory compliance within Vericel.
- Experience in high volume and fast-paced materials, Manufacturing Support, and cleanroom environment.
- Able to complete assignments with attention to detail and high degree of accuracy.
- Organizational planning skills and the ability to collaborate with others in a team environment.
- Excellent communication skills, written and verbal.
- Experience with Microsoft Word and Excel.
Working Conditions and Physical Demands:
- May be required to work in classified and controlled areas such as clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.
- May be required to stand for long periods of time while performing physical duties.
- Must be able to lift, carry, push and pull up to 40 lbs.
- Able to work a flexible schedule including weekends and/or holidays as required to meet production demands.