The primary role of the Laboratory Compliance Technician is to execute specified administrative and support activities for the Analytical, Microbiology, and Stability Departments. In addition, the Laboratory Compliance Technician will be responsible for ordering, inventory of materials, and tracking maintenance and calibration of all laboratory equipment.  The following characteristics are essential in order to be a contributing team member in the Analytical Compliance Department: ability to multi-task in a fast-paced environment, open to working flexible hours and shifting priorities based on laboratory needs, ability to document data according to cGMPs, organized, and dependable.  

Responsibilities:

• Responsible for ordering and inventory of materials


• Responsible for tracking and performance of maintenance and calibration of laboratory equipment as assigned 


• Document and review of raw and final data to ensure complete and proper documentation according to procedures and applicable cGMPs.


• Notify Laboratory Management of laboratory problems.


• Responsible for practicing all applicable cGMPs


• Responsible for ensuring logbooks are closed out and new ones acquired


• Responsible for product receipt, product request, and review of applicable documentation


• Entering laboratory metric data


• Batch record management for laboratories (receipt, delivery, metrics tracking)


• Responsible for the general maintenance of the laboratory including good housekeeping (and a safe working environment).  Duties include but not limited to:


• Glassware, Pipets, etc. (cleaning, maintaining)


• Inventory (Lab Supplies, Chemicals, Reagents, Standards, Columns, Media, etc.) 


• Housekeeping, cleaning, and organizing


• Waste removal


• Maintenance of emergency showers and eyewash stations


• Replace Desiccants. 


• Temperature monitoring/recording


• Administrative duties


• Data scanning, database entry, coordinating documents ready for off-site storage 


• Follow Standard Operating Procedures, safety, health, and cGMP Guidelines.
  
   

• 0 - 2 years’ experience in laboratory environment, preferred


• High school degree, technical degree preferred


• Proficiency with current word processing, spreadsheets, and database software required


• Ability to participate in and contribute to a team-oriented work environment by developing positive working relationships within the laboratory and between other departments.