What are the responsibilities and job description for the Manager Quality Lab Services position at Renaissance Lakewood, LLC?
Technical
- Provide guidance to direct reports and laboratory personnel in the interpretation of quality issues.
- Work with R&D and QC organizations to support the successful validation, verification, qualification, and transfer of analytical test methods for release testing.
- Support drafting of standard operating procedures.
- Routinely recognize and resolve quality issues. Seek management guidance on complex issues.
- Assist Quality and Laboratory Services management in the development, implementation, and revision of the Laboratory Quality System.
- Collaborate with the Laboratory Director and Manager to ensure that quality assurance standards and procedures are in place to meet or exceed those necessary to maintain cGMP compliance.
- Manage the monitoring of Laboratory practices to verify compliance with Quality System policies and procedures.
- Perform spot-checks in the QC Labs to ensure compliance with written regulations, policies, procedures, and global procedures.
- Schedule and coordinate formal quality laboratory audits.
- Manage quality audits of the Laboratory Services laboratories to verify adherence to the established Laboratory Quality System procedures.
- Review and approve laboratory Qualification protocols and reports.
- Calibration records and logbooks of instruments and keep maintenance records including the refrigeration logs, pipette checks, and balance checks.
- Review and approve Chemical Introduction Change Controls to ensure that appropriate quality standards are implemented.
- Provide management and oversight of the daily activities of the Chemical Introduction and Quality Laboratory Services.
- Participate in the recruitment and selection of employees for the QA Group.
- Plan and schedule work for the group to ensure proper distribution of assignments.
- Plan and conduct meetings with subordinates to ensure compliance with established practices, to implement new policies and to keep employees abreast of current changes and standards.
- Monitor employee performance and provide appropriate and timely recognition of their contributions.
- Ensure adequate training and development opportunities for QLS employees.
- Assist employees in setting career goals and managing career expectations.
- Provide guidance as requested regarding hiring, training, promotions, and disciplinary issues for technical personnel.
- Understand and comply with all Renaissance safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state and local regulations.
