Job Description
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.
Job Tags
Full time,