Quality Improvement Technician

Role Summary

Quality Improvement Technician responsible for developing and improving control systems to support production of API molecules, collaborating with Process Team to measure, evaluate, and improve safety, quality, throughput, and cost with a safety-first, quality-always mindset. Role supports startup and GMP operations, with emphasis on building processes and culture for a greenfield manufacturing site.

Responsibilities

• Coordinate cleaning, turnaround, and maintenance activities in the production area.
• Design and maintain the required turnaround documentation.
• Review and monitor relevant SOPs and SOP updates; execute unplanned SOP changes.
• Influence adherence to cycle time.
• Coordinate housekeeping and fit and finish programs.
• Assist Operations staff in planning and scheduling daily work.
• Support Process Engineers in daily operations.
• Ensure requests/concerns from Operators are logged and followed up.
• Identify and support implementation of improvements from Operations.
• Own issuance of non-routine work instructions with input from Process Chemists/Process Engineers.
• Organize/complete non-routine sample/repackaging.
• Generate work orders for corrective maintenance.
• Assist in training of operations personnel.
• Understand Health, Safety & Environment regulations and application of safety/process safety standards.
• Understand other area processes and their hazards and respond appropriately.
• Participate in safety audits, procedure coordination, housekeeping and improvement projects.
• Follow cGMP practices, safe work habits, hygiene standards, and housekeeping requirements relevant to the role.

Qualifications

• High School Diploma or equivalent
• Legally authorized to work in the United States; sponsorship not anticipated
• Completion of Post Offer Exam or Work Simulation if applicable
• Excellent written and verbal communication; basic computer skills

Additional Preferences

• Experience in facility/area startup environments
• Experience in pharmaceutical manufacturing with PSM-regulated/hazardous chemicals
• Understanding of FDA guidelines and cGMP requirements
• Strong organizational skills and multi-tasking ability
• Knowledge of lean manufacturing principles
• Flexibility to troubleshoot and triage challenges
• Ability to understand technical nomenclature and mathematical formulas
• Manual material handling as appropriate
• Ability to bend, reach, climb ladders, and work in tight spaces; stand for long periods

Education

• High School Diploma or equivalent

Additional Requirements

• Ability to work flexible schedules during startup period
• Ability to work overtime as required