The Quality Control Lab Manager will ensure all QC activities associated with the testing, approval and release of the site’s products. The QC manager will be responsible for ensuring timely, accurate and reliable testing of various types of samples such as raw materials, intermediates, and finished products. The QC manager must coordinate activities to support daily production requirements and optimize the use of laboratory resources. In addition, the QC manager is responsible for strong leadership and expertise in building and managing an in-house staff of qualified QC Analysts/Chemists.
|Duties & Responsibilities|
- Responsible for the hiring, management, training, counseling/coaching, and motivation of the QC staff. Manages the daily activities of the staff members, ensuring that all QC activities (including execution of monitoring and test programs) are successfully performed and completed in a timely manner. Provide for operational flexibility by creating staff cross-training across all QC functions
- Perform test of raw materials, components, in-process and finished product and/or stability samples including, assay, and endotoxin/aseptic testing, and other test in accordance with the prescribed analytical methods, USP, EP, BP, JP, ACS, ASTM and procedures utilized in an GMP regulated laboratory environment. Manages water quality monitoring and testing
- Identify and troubleshoot problems, that may arise with instrumentation and/or during analytical preparation, while at the same time ensuring method optimization. For results not meeting specification or expectations, ensure prompt investigation, identifying possible sources for noncompliance, and identifying corrective action(s) going forward
- Analyze and interpreting test results using appropriate instrumentation such as GC, UV, IR, pH, etc. Utilizing the instrument specific data processing software, undertake the analytical process, reporting the results
- Accountable for ensuring testing and analysis is handled consistently from startup through product release, identifying opportunities for continuous improvement and ensuring utilization of industry best practices
- Keeps current on QC practices, the competitive environment, regulatory or scientific trends, as well as general industry standards and regulatory requirements pertinent to QC responsibilities
- Develop, review, and maintain SOP’s pertinent to QC responsibilities
- Responsible for preventive maintenance, calibration, and standardization of lab instruments
- Overall management for ordering and maintaining laboratory reagents and consumables
- Responsible for the timely and accurate printing of batch records and labels to meet production demands
- Participate in external audits by providing objective evidence of compliance to the Quality Management System
- Ensure data integrity and document management protocols are followed.