Overview
Quality Assurance Associate Jobs in Trenton, NJ at TCG GreenChem Inc.
Title: Quality Assurance Associate
Company: TCG GreenChem Inc.
Location: Trenton, NJ
If you have 5+ analytical, and quality assurance experience in an API (Active Pharmaceutical Ingredient) development and scale up manufacturing facility and a BS or MS (Chemistry) degree this may be the job for you.
This position is primarily responsible for supporting quality assurance and compliance programs at TCG GreenChem, Inc.
Principal Duties And Skills
Ensure compliance with cGMP, Environmental Health and Safety, and company SOPs, policies during all phase of operations
Participate in and conduct daily activities in accordance with the Quality Operations and Systems to support manufacturing, laboratory, and warehouse
Responsible for lifecycle management and maintenance of Quality documentation such as, but not limited to: Standard Operating Procedures, Training records, Logbooks, Master Batch Records, Production Batch Records, Investigations, Change Controls, CAPAs, Vendors, Protocols, Reports, Quality Agreements, Equipment Qualifications and/or Validation documentation
Issuance and review of batch records to assure internal requirements for the product quality and overall review of documents for cGMP compliance
Perform inspection of cGMP areas for compliance to policies and procedures
Perform investigational activities and prepare investigation reports, incident reports, change controls, as required
Review of protocols, reports, and raw data
Quality release of raw materials, intermediates, and finished products
Participate in audit/inspection
Exceptional communication skill in writing and verbal
Proficient in MS office
Perform other duties as assigned
Minimum Qualifications Required:
BS or MS (Chemistry) and 5+ years relevant experience, preferably in API development and scale up / manufacturing facility.
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