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Production Technician
3 months ago
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*Completes batch records in accordance with FDA and Current Good Manufacturing Practices (cGMP) guidelines
*Provide process support and troubleshooting necessary to meet all customer requirements
*Maintain the facility in excellent FDA/cGMP posture
*Responsible for safety equipment and active participation in safety program and hazard analysis
*Ensures that waste is appropriately characterized, labelled, stored and disposed in compliance with all Company, state and federal regulations. Works collaboratively with Environmental, Health & Safety, as appropriate.
*Assures all production/support equipment is in proper operating condition and that all production equipment is appropriately labelled with a current status tag. Works collaboratively with Maintenance, as appropriate.
*Ensures the security and safe handling of all controlled substances at all times. Strictly adheres to all Company and DEA regulations.
*Ensures a level of housekeeping appropriate for a pharmaceutical manufacturer and maintain 5S areas.
*Active member of Emergency Response Team. Participate in Emergency Response Training and related activities.
*Promotes a positive work environment by maintaining a safe work area and ensuring that their team members have the knowledge, skills and appropriate tools to perform their assigned duties and a thorough understanding of their performance expectations.
*Provides prompt, appropriate feedback to team members, both positive and constructive, in a continuing effort to develop employees to their full potential.
*Demonstrates a professional and positive attitude, integrity and a strong work ethic and encourages team members to do the same.
*Cooperate with all root cause investigations and follow corrective actions and compliance with Company policies and procedures, and all state and federal regulations occurs within department.
Qualifications:
*High School Diploma with 5
-7 years of experience in an API Manufacturing facility
*AA in Chemistry, Engineering, or other related technical field with 3
-5 years of experience
*BS in Chemistry, Engineering or other related technical field
*Obtain and maintain certification as forklift operator
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