The Role
The Quality Assurance Associate at TCG GreenChem is responsible for ensuring compliance with quality assurance and cGMP standards, overseeing quality documentation, performing inspections, supporting investigations, and conducting audits. Strong communication skills and proficiency in MS Office are essential.
Summary Generated by Built In
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:
MS (Chemistry) and 5+ years relevant experience, preferably in API development and scale up / manufacturing.
The Company
What We Do
Offering Seamless CMC Development Services Including Process Research & Development and Delivery of cGMP APIs
