About This Role
This night-shift role involves overseeing the Quality Control function at the site, ensuring compliance with regulatory requirements through testing, trending, continuous improvement, and reporting. The manager will lead a team of analysts and technicians, ensuring safe and compliant laboratory operations.
Responsibilities
- Manage and prioritize testing and operations of quality control team(s) involving samples as well as incoming, in-process and final products
- Ensure that the QC functions are completed in accordance with Company and governmental standards of safety and quality, and that all experimental documentation is complete and timely
- Supervise a team of analysts and technicians including, but not limited to, the motivation, education, efficiency, performance management and productivity of these individuals
- Ensure that laboratory operations are conducted in a safe manner and follow safety rules fully
- Maintain compliance with regulations at all levels as well as strict adherence to standard operating procedures and cGMPs as necessary
- Organize workload and coordinate activities in order to carry out multiple projects concurrently and in accordance with established objectives, timelines and deadlines
- Drive schedule adherence discipline and RFT performance with the supervisors and analysts
- Be responsible for lab inspection readiness at all times
- Be responsible for customer requests related to QC items
- Ensure the team compliance on initiating deviations, completing investigations and extensions to maintain regulatory compliance
- Ensure supervisors adhere to supervisor standard work for shift huddles
- Ensure there is a shift hand off process in place to transition QC operational activities
- Manage all investigations of OOS, deviations and change control management and CAPAs within the QC function
- Oversee and perform pharmaceutical analysis to support operations
- Mentor and train team members on applicable techniques and equipment
Requirements
- Bachelor’s degree in Chemistry, Analytical Chemistry or related field
- Minimum 5-8 years’ experience in a GMP or GLP environment working with Chromatography (HPLC/UPLC/GC), extensive method development and/or validation
- Minimum 2 years’ experience in professional management
- Experience in playing a key role in regulatory inspections
- Ability to recognize what needs to be done, take action, and accomplish results
- Strong oral and written communication skills, including effective listening
- Demonstrated ability to effectively utilize team resources
- Expert in cGMP, USP, EP and FDA regulations
- Technical competence including the understanding of theory and interpretation of all lab techniques
