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Quality Control Specialist

2 months ago

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

This role is primarily focused on enhancing quality assurance and compliance initiatives at TCG GreenChem, Inc.


Key Responsibilities and Skills
  • Ensure adherence to cGMP, Environmental Health and Safety standards, and internal SOPs throughout all operational phases.
  • Engage in daily tasks aligned with Quality Operations and Systems to support 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 documentation.
  • Issue and review batch records to confirm internal product quality requirements and conduct comprehensive document reviews for cGMP compliance.
  • Conduct inspections of cGMP areas to ensure conformity with policies and procedures.
  • Carry out investigational activities and compile investigation reports, incident reports, and change controls as necessary.
  • Review protocols, reports, and raw data meticulously.
  • 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.
Minimum Qualifications:
Master's degree in Chemistry with over 5 years of relevant experience, ideally in API development and scale-up/manufacturing.

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