Purpose :
The QC Data Reviewer is an exempt level position responsible for reviewing all data produced by the Quality Control Lab during Raw material testing, In-Process and release Drug Product QC Testing, related to the manufacturing of drug products for commercial operations in a controlled GMP environment .
Responsibilities :
- Data reviewer is responsible for reviewing the laboratory data while ensuring compliance.
- Conduct the data review of data pertaining to routine laboratory testing for raw materials, in-process materials, finished product and stability samples in accordance with approved analytical methods.
- Performs data review as needed for the calibration and routine maintenance of lab equipment as necessary.
- skilfully and accurately verify notebooks and raw data and other official documentation as needed to support the release of drug products and raw materials.
- Coordinate review to ensure all materials are reviewed and released in a timely manner to meet production schedule.
- Document/Receive daily analysis samples including but not limited to Raw materials, In-process, Finished products, Stability, Packaging samples in QC laboratory.
- Maintain accurate and detailed QC analytical data and logbooks.
- Ensure the laboratory is in Inspection ready state and running in cGMP Compliance.
- Adhere to cGMP (current Good Manufacturing Practices) regulations and company policies to ensure compliance with industry standards and regulations.
- Participate in training sessions to stay updated on new processes, technologies, and regulatory changes.
- Work closely with supervisors, quality assurance personnel, and other departments to ensure cGMP compliance & regulations.
- Utilization of electronic systems (LIMS) for review and approval of cGMP data.
- Assists with additional work duties or responsibilities as evident or required.
Qualifications :
- Must possess strong analytical skills and problem-solving ability, and show attention to detail, understanding of cGMP regulations pertaining to laboratory controls and knowledge of USP and compendia standards.
- Advanced laboratory skills, basic knowledge of statistical method.
- Strong technical skills.
- Ability to handle multiple tasks concurrently, and in a timely fashion.
- Computer literate.
- Must be able to communicate effectively with supervisors and peers.
- Must demonstrate effectiveness in ability to train others, empowerment, leadership, results, orientation and task completion.
Skills:
- Must possess strong analytical skills and problem-solving ability, and show attention to detail, understanding of cGMP regulations pertaining to laboratory controls and knowledge of USP and compendia standards.
- Advanced laboratory skills, basic knowledge of statistical method.
- Strong technical skills.
- Ability to handle multiple tasks concurrently, and in a timely fashion.
- Computer literate.
- Must be able to communicate effectively with supervisors and peers.
- Must demonstrate effectiveness in ability to train others, empowerment, leadership, results, orientation and task completion.
- Must be able to accommodate a flexible work schedule (weekends, shift, etc.) which may be required for business needs.
