Production Technician (Night Shift)

The Production Technician is responsible for the safe, cost effective, and timely manufacture of product that is fit for intended use and meets customer requirements and production schedule.

Core Responsibilities: 

• Completes batch records in accordance with FDA and Current Good Manufacturing Practices (cGMP) guidelines.
• Demonstrates technical proficiency and self-assuredness in applying cGMP standards.
• Provide process support and troubleshooting necessary to meet all customer requirements.
• Maintain the facility in excellent FDA/cGMP position.
• Responsible for safety equipment and active participation in safety program and hazard analysis. Wears appropriate PPE for task.
• 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 documented with current status. 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 teammates, 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. 
• Responsible for contributing to audit readiness and for participating in EH&S audits with internal Company groups, regulatory agencies, and customers.
• Responsible for reporting all near misses, accidents, and dangerous occurrences through the appropriate Company procedures to ensure an investigation is initiated.
• Effectively communicates with QC Testing group regarding timing and prioritization of in-process sample requirements.
• Operates machines and equipment that involves set up and making adjustments to regulate temperature, pressure, flow and reactions or materials safely and in accordance with batch record and work instructions.
• Basic batch processing and unit operations.
• Participates in regular Peer to Peer training for routine tasks.
• Execution is within well-defined procedures with assistance readily available.

Qualifications: 

Required

• High School Diploma with 3-5 years' experience in an API manufacturing facility.
• While performing the duties of this job it is required to stand, walk, and use hands to operate objects, tools, or controls; reach with hands or arms; climb, balance, stoop, kneel, or crouch when necessary for job activity.
• Able to lift 50lbs and occasionally lift and or/move more than 100 pounds using available material handling equipment.
• Must be willing to work a rotating shift
• Obtain and maintain certification as forklift operator
• Solid understanding of GMP and FDA
• Safety Awareness
• Authenticity and motivation to contribute to team success
• Ability to independently apply scientific and/or technical knowledge in the performance of job duties