• Pre-clinical/Life Sciences
  • Salem, NH

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.

Submit Resume

To apply for this job email your details to info@clinlabstaffing.com