Summary of Job Duties:
The Quality Control (QC) Lab Manager is a leader in a GMP compliant environment under the guidance of and reporting to the Quality Director. Duties are to work with the QC Leadership team to manage all QC lab activities. This role will make decisions concerning various QC testing processes and dispositioning of test results, oversee QC staff training, lab testing equipment calibration and repair, participate in the creation and implementation of departmental policy and procedures, and interact effectively with other departments to accomplish Quality and Company goals.
Specific Job Duties:
1. Independently lead and manage the QC lab, but meet regularly with the Quality Director, QC Manager, and QC Lab staff to discuss lab priorities and any upcoming tasks or projects.
2. While maintaining independent QC lab management authority and responsibility, work cooperatively with QC leadership by closely and continuously overseeing daily lab operations, making decisions concerning various QC processes and investigations, testing equipment scheduling for production, method development and research needs, and helping to interpret / review data related to out-of-specification test results or raw material/product failure.
3. Guide the training and goal development of new and continuing laboratory personnel through orientation plans, review and approval of training / refresher training documentation and participating / conducting regular one-on-one performance discussions with employees. Be responsible for monitoring and managing all QC staff working in the laboratory areas for compliance with lab safety, operational procedures and practices.
4. Be responsible for the continued operation and appropriate utilization of all lab equipment, including maintenance of up-to-date chemical inventory processes to maintain predictable lab testing services that support the desired department and company performance metrics. Participate in and drive the review and creation of new and existing departmental KPI metrics with lab task area teams.
5. Help initiate and coordinate the regular review of internal QC policies and procedures (audit of equipment logs, test logbooks, SOP’s etc.) to help ensure company compliance with GMPs and other regulatory guidelines (FDA, EPA, OSHA, AQMB, etc.).
6. Guide staff in resolving instrumentation troubleshooting and repair issues, out-of-specification investigations, and work through and appropriately communicate unexpected equipment or product failures and personnel issues.
7. Attend meetings with other Departments to determine how QC activities need to be directed and implement those determinations to achieve company goals. Participate actively in ongoing company projects and initiatives.
8. Receive training in teambuilding and management skills by proactively seeking coaching, mentoring and training from other management team members, as well as threshold training and workshops as available.
9. Write reports, memos or create computer presentations relating to QC laboratory operations and specific investigations and assist with the compilation of test results.
10. Perform all tasks assigned by Threshold management.
Minimum Qualifications Required:
1. B.S. Degree in Chemistry, Biology, Biochemistry Chemical engineering or related field, or equivalent experience.
2. 4 years analytical experience, including supervisory experience with proficiency in HPLC, GC, ICP-MS or similar instrumental analysis, implementation experience for HPLC and general analytical chemistry laboratory techniques, and troubleshooting of equipment and methods.
3. Good Microsoft Office skills—data collection, report writing, and graph production.
4. Demonstrated skills in teamwork, collaboration, and effective communication.
Skills and/or Training Desired: