Production Technician

Job purpose

• Manufacture of bulk API pharmaceuticals in accordance with customer and internal specifications.

Principal accountabilities

• 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.

Scope

• 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.

Special factors

• 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

Qualifications/ knowledge/ experience

• 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