Quality Control Specialist
1 week ago
This role is essential for supporting the quality assurance and compliance initiatives at TCG GreenChem, Inc.
Key Responsibilities and Skills:
- Ensure adherence to cGMP, Environmental Health and Safety standards, and company SOPs throughout all operational phases.
- Engage in daily activities aligned with Quality Operations and Systems to facilitate manufacturing, laboratory, and warehouse functions.
- Oversee the lifecycle management and upkeep of Quality documentation, including but not limited to: Standard Operating Procedures, Training records, Logbooks, Master Batch Records, Production Batch Records, Investigations, Change Controls, CAPAs, Vendor documentation, Protocols, Reports, Quality Agreements, Equipment Qualifications, and Validation records.
- Issue and review batch records to confirm compliance with internal product quality requirements and conduct overall document reviews for cGMP adherence.
- Conduct inspections of cGMP areas to ensure conformity with established policies and procedures.
- Carry out investigational tasks and compile investigation reports, incident reports, and change controls as necessary.
- Review protocols, reports, and raw data for accuracy and compliance.
- Quality release of raw materials, intermediates, and finished products.
- Participate in audits and inspections.
- Demonstrate exceptional written and verbal communication skills.
- Exhibit proficiency in MS Office applications.
- Perform additional duties as assigned.
Master's degree in Chemistry with over 5 years of relevant experience, preferably in API development and manufacturing processes.
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