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