Job Description
Overview:
This position is responsible for the manufacture of sterile pharmaceutical products. In addition, employee will perform preparation, compounding, filling and routine facility monitoring.
Responsibilities:
The employee should successfully meet schedules in a high quality and professional manner and ensure production/packaging areas and work areas conform to cGMP, Standard Operating Procedures and Corporate Policies. Maintain the GMP areas in a state of control at all times.
This employee will independently perform dispensing, manufacturing, and packaging operations following approved Batch Records and routine trouble-shooting and cleaning of complex equipment. Specifically, this person will perform the following duties adhering to written Standard Operating Procedures (SOPs) or written work instructions:
- Finished Product Inspection and Labeling
- Restock Manufacturing Consumables
- Preparation Room Activities
- Material preparation including component washing and sterilization
- The set-up, change-over, programming and operation of various manufacturing equipment
- Compounding Room Activities
- Prepare stock solutions and drug products
- The set-up, change-over, programming and operation of various manufacturing equipment
- Fill Room Operations
- Operate in the Class 100 Hood
- Manual Aseptic Filling
- Use of Filling Pumps, Crimper, Capping Machine and Torque Tester
- Cleaning
- Documentation
- Complete all documentation as per Bio-Concept procedures and policies and cGMP regulations
- Review controlled documents such as sterilization and cleaning logs for accuracy and completeness
- Assist in revising and writing SOPs relevant to this job function
- Perform Environmental Monitoring of the Aseptic Manufacturing Suite
- Assist in equipment qualifications
Qualifications:
Education and Experience: High School degree or equivalent (GED) plus 2 – 5 years experience in a cGMP regulated manufacturing environment or at least 1 year experience in Sterile Fill Finish. Computer skill in Microsoft Excel and Word required. Good verbal and written communication skills.
To apply for this job email your details to info@clinlabstaffing.com