Job Description
Lead a high-performing Quality laboratory team responsible for final batch release and complaints processes, delivering exceptional quality and safety standards.
The Quality Lab Leader is responsible for managing the final batch release and complaints processes for commercial products, including outsourced activities. Key responsibilities include:
- Implementing and qualifying laboratory equipment, processes, and test methods for product release and complaints testing
- Identifying product defects and potential issues, analyzing data, and trending results
- Supporting the continuous improvement of testing and quality assurance processes
- Providing technical support on equipment and methods, and managing complex issues with a high level of autonomy
Additional responsibilities include:
- Managing and maintaining calibration and preventive maintenance of laboratory equipment
- Communicating with suppliers to drive on-time completion of activities
- Coordinating repairs and remediation activities, as needed
- Driving investigation activities for out-of-specification calibration results
- Maintaining laboratory safety and organization, as well as operational and functional conditions
- Managing inventory and related documentation, including laboratory supplies, test samples, and chemicals
- Identifying and implementing continuous process improvements in the laboratory, as well as contributing to lab network initiatives
- Leading or contributing to root cause investigations and corrective/preventive actions, as needed
- Identifying and supporting qualifications of new lab suppliers, when needed
- Supporting Supplier Quality team with maintenance activities for existing suppliers
- Assisting with failure or non-conformance investigations
- Supporting audits (regulatory, customer, internal) as a subject matter expert
- Performing internal audits and compliance assessments, when needed
- Leading change management activities for lab processes
- Supervising technicians performing complaints and/or release activities
- Conducting on-boarding and ongoing training programs for lab associates
The Quality Lab Leader will also be responsible for managing and driving completion of commercial product complaints activities, including planning, sample management, investigations, reporting, and oversight of activities performed by support teams and/or suppliers.
Key qualifications include:
- Bachelor's degree in Engineering, Science, or related discipline
- Up to 5 years of experience in a similar role in the pharmaceutical, medical device, diagnostics, or quality control industry
- Knowledge of mechanical measurement and testing equipment, and CT scanners
- Understanding of industry standards and regulations, such as ISO, FDA, OSHA, and ASTM
- Excellent written and oral communication skills, and superior attention to detail
- General knowledge of problem-solving and root cause analysis methodology, and statistical techniques
The ideal candidate will have a strong background in electromechanics and/or electromechanical devices, with experience in troubleshooting and equipment qualification desirable.