PC Inspector Lead

The Lead Process Control Inspector will be responsible for the execution and completion of tasks performed by the PC Inspectors. The Lead Process Control Inspector will work with the PC Inspectors to ensure the proper inspection and documentation of filling and/or packaging, line clearance, fill volume checks, and physical inspections of bulk and finished product. Also responsible for all training required of the PC Inspector position.

Responsibilities:

• Provide feedback to Management for continuous improvement efforts for department.
• Perform physical inspection of product according to established procedures.
• Perform QC sampling for retains and QC laboratories.
• Maintain proper batch record documentation of all inspection activities.
• Proper documentation of product defects, investigation and resolution of deviations, and corrective actions performed.
• Point of contact to facilitate corrections and provide feedback to PC Inspectors.
• Review/approve inspections in LIMS and release product in ERP system.
• Assist the PC Management where necessary with investigations, incidents, deviations, and completion of required stability testing.
• Assist with Freeweigh system administration as needed.
• Coordinate coverage for vacations and special projects.
• Evaluation of NovaSeptum samples each shift.
• Review of lab documentation for accuracy and adherence to cGMP documentation standards.
• Review of filling and packaging sections of Batch Records.
• Participate in all internal and external TRC Training Programs.
Follow Standard Operating Procedures, safety, health, and cGMP Guidelines.

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• At least six years of experience as a Process Control Inspector
• High School Diploma or GED
• Proficient with current word processing and database software
• Knowledge of basic statistical sampling plans and calculations
• Strong interpersonal, group skills, and ability to communicate effectively