Quality Assurance Associate - TCG GreenChem Inc

Job Summary

This position is primarily responsible to support Quality Assurance and Compliance programs at TCG GreenChem, Inc.

Principal Duties and Skills

1. Ensure compliance with cGMP, Environmental Health and Safety, and company SOPs, policies during all phase of operations.
2. Participate in and conduct daily activities in accordance with the Quality Operations and Systems to support manufacturing, laboratory, and warehouse.
3. Responsible for lifecycle management and maintenance of Quality documentation such as, but not limited to:
   1. 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.
4. Issuance and review of batch records to assure internal requirements for the product quality and overall review of documents for cGMP compliance.
5. Perform inspection of cGMP areas for compliance to policies and procedures.
6. Perform investigational activities and prepare investigation reports, incident reports, change controls, as required.
7. Review of protocols, reports, and raw data.
8. Quality release of raw materials, intermediates, and finished products.
9. Participate in audit/inspection.
10. Exceptional communication skill in writing and verbal.
11. Proficient in Microsoft Office.
12. Perform other duties as assigned.

Job Qualifications

• MS in chemistry and 5 years relevant experience preferably in API development and scale up / manufacturing
• Ability to communicate effectively both in verbal and written forms in inter-disciplinary environments
• Must be able to work in a team environment

Skills Required

• Excellent verbal and written communication
• Proficient in Microsoft Office
• Critical thinking
• Problem solving
• Active listening
• Out-of-the-box thinking
• Proactivity
• Knowledge of technology trends
• Knowledge of regulatory requirements
• Energetic
• Ability to multitask

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