What are the responsibilities and job description for the Production Technician position at Veranova?
Job Purpose
- Manufacture of bulk API pharmaceuticals in accordance with customer and internal specifications.
- 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 maintain5S 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.
- Effectively communicates with QC Testing group regarding timing and prioritization of in-process sample requirements.
- 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.
- Demonstrates technical proficiency and self-assuredness in applying cGMP standards.
- Applies cGMP concepts in association with department specific responsibilities.
- Ensures all documentation produced is in compliance with cGMP standards.
- Responsible for contributing to audit readiness and for participating in quality audits with FDA, other Regulatory Agencies and customers, as needed.
- Walking, standing for long periods of time while in plant, reaching, handling, twisting, and bending spine at waist when operating equipment.
- Able to lift 50lbs
- 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
- Solid understanding of GMP and FDA
- Familiarity in 5S/Kaizen concepts.
- Ability to independently apply scientific and/or technical knowledge in the performance of job duties
Production Technician
Veranova L P -
West Deptford, NJ