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QC Testing Coordinator
2 months ago
Position Overview:
The Quality Control Analyst plays a crucial role in ensuring the integrity and quality of products through meticulous testing and compliance with regulatory standards.
Key Responsibilities:
- Execute batch evaluations and stability assessments promptly, ensuring Quality Control testing and documentation of raw materials, in-process, bulk drug substance, final products, and stability samples adhere to GMP standards and relevant regulations.
- Administer the stability study program, overseeing sample storage and management of retention samples for both in-process and final products.
- Act as the system owner for QC equipment, facilitating equipment reviews, monitoring performance, and maintaining calibration statuses.
- Manage deviations and investigations effectively, ensuring laboratory documentation is completed in a timely manner.
- Draft and revise Standard Operating Procedures (SOPs), guidelines, protocols, and other essential QC documentation.
- Evaluate data to ensure compliance with Data Integrity standards.
- Support departmental and site audit preparedness and engage in continuous improvement initiatives.
- Calibrate QC testing equipment and inform relevant personnel of any calibration discrepancies.
- Maintain QC information systems and stay updated on regulatory requirements pertaining to GMP, safety, and environmental policies.
- Assist in investigations of quality incidents and participate in problem-solving discussions, ensuring QMS documentation is completed promptly.
- Engage in scientific and technical meetings and conferences to stay informed of industry advancements.
- Perform routine maintenance of equipment and laboratory facilities.
- Be prepared to provide support across departments as necessary and undertake additional responsibilities as directed by the QC Manager.
Essential Competencies:
- Meticulous attention to detail
- Dependability and reliability
- Strong communication skills
- Comprehensive understanding of scientific and technical processes
