Quality Control Specialist

1 week ago


Trenton, New Jersey, United States TCG GreenChem Inc Full time
Position Overview

This role is essential for supporting the quality assurance and compliance initiatives at TCG GreenChem, Inc.


Key Responsibilities and Skills:
  • Ensure adherence to cGMP, Environmental Health and Safety standards, and company SOPs throughout all operational phases.
  • Engage in daily activities aligned with Quality Operations and Systems to facilitate manufacturing, laboratory, and warehouse functions.
  • Oversee the lifecycle management and upkeep of Quality documentation, including but not limited to: Standard Operating Procedures, Training records, Logbooks, Master Batch Records, Production Batch Records, Investigations, Change Controls, CAPAs, Vendor documentation, Protocols, Reports, Quality Agreements, Equipment Qualifications, and Validation records.
  • Issue and review batch records to confirm compliance with internal product quality requirements and conduct overall document reviews for cGMP adherence.
  • Conduct inspections of cGMP areas to ensure conformity with established policies and procedures.
  • Carry out investigational tasks and compile investigation reports, incident reports, and change controls as necessary.
  • Review protocols, reports, and raw data for accuracy and compliance.
  • Quality release of raw materials, intermediates, and finished products.
  • Participate in audits and inspections.
  • Demonstrate exceptional written and verbal communication skills.
  • Exhibit proficiency in MS Office applications.
  • Perform additional duties as assigned.
Required Qualifications:
Master's degree in Chemistry with over 5 years of relevant experience, preferably in API development and manufacturing processes.

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