Overview
Quality Assurance Associate Jobs in Trenton, New Jersey, USA at TCG GreenChem Inc.
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If you have 5+ years of analytical and quality assurance experience in an API (Active Pharmaceutical Ingredient) development and scale-up manufacturing facility and a BS or MS in Chemistry, this may be the job for you.
This position is primarily responsible for supporting quality assurance and compliance programs at TCG Green Chem, Inc.
Principal Duties And Skills:
Ensure compliance with cGMP, Environmental Health and Safety, and company SOPs during all phases 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 product quality and overall review of documents for cGMP compliance.
Perform inspection of cGMP areas for compliance with 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 skills in writing and verbally.
Proficient in MS Office.
Perform other duties as assigned.
Minimum Qualifications Required:
BS or MS in Chemistry and 5+ years of relevant experience, preferably in API development and scale-up/manufacturing facility.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Internet Publishing
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Title: Quality Assurance Associate
Company: TCG GreenChem Inc.
Location: Trenton, New Jersey, USA
Category: Quality Assurance – QA/QC (Data Analyst)
