Laboratory Manager I

Duties And Responsibilities

• Efficient and effective planning of workflow in the microbiology and analytical chemistry laboratory.
• Ability to delegate tasks and workload in a manner that ensures the timely completion of testing and scheduled laboratory tasks.
• Laboratory tasks include but are not limited to: routine laboratory maintenance, SOPs reviews, re-training etc; effectively delegate non-scheduled events such as projects;
• Proactively evaluate laboratory workflow for continuous improvement opportunities to enhance efficiency and effectiveness of the services we provide to our clients.
• Maintain and/or establish metrics for the Laboratory to understand and manage the efficiency and effectiveness of the group and/or individuals.
• Utilize these metrics to mitigate risks, improve performance, and/or to celebrate group accomplishments.
• Maintain and ensure compliance with cGMP and ISO 17025 systems.
• Ensure compliance with applicable SOPs, review, and revision of SOP’s, test methods etc.
• Create and/or review of protocols, technical reports, data collection sheets, logbooks, and raw data.
• Ensure employees are properly trained in labs systems, methods, SOPs etc.
• Proactively evaluate the laboratory’s quality systems for gaps in current compliance standards and/or industry trends for compliance.
• Capable of hosting tours of the micro-laboratory by regulatory or client auditors and serve as a microbiology Subject Matter Expert (SME) if called upon.
• Participation in client interactions and support client requested initiatives; may include internal studies and special projects; write protocols, interpret data, and/or write technical reports; work with client services to build relationships with existing clients, expand relationships with existing clients, and strive to provide opportunities for the client to have an exceptional experience.
• Proactively develop staff. Coach and provide feedback on job performance. Complete annual performance evaluations and identify development opportunities. Assist with training new hires and cross-train existing staff. Identify and develop strong performers in the microbiology laboratory to establish next generation of management and/or technical leaders.
• Responsible for initiating and/or conducting investigations for OOS, deviations, CAPA’s, change controls according to the quality system.
• Identify trends related to “laboratory as cause” OOS investigations and deviations, and conduct CAPA to eliminate these trends.
• Develop staff’s technical and/or problem-solving skills (investigational) skills to drive for root cause.
• Maintain a safe work environment in a GMP/FDA-regulated environment according to OSHA Laboratory Standard.
• Comply with the Chemical Hygiene Plan and accident reporting. Establish systems for ensuring a high-level lab hygiene.
• Managing the business of the Laboratory. Awareness of business laboratory’s performance against annual fiscal/budgetary targets. Manage resources to exceed annual fiscal/budgetary targets.
• Keep abreast of new technologies and/or compliance trends related to the lab. Propose and potentially lead efforts to implement new technologies and/or mitigate gaps in the lab’s cGMP systems.
• Foster a culture of “continuous improvement” in the laboratory and throughout the organization. Ability to react to change productively and effectively lead and /or manage change.
• Perform other essential tasks, projects, and responsibilities as required.

Skills & Proficiencies

• Practical experience in lab operations (optimization & development)
• Experience troubleshooting & problem-solving
• Familiarity with maintaining and operating specific laboratory instruments is preferred
• Practical experience with USP methodologies for consumer goods, medical devices and industrial chemicals
• Demonstrated equipment and method validation experience
• Experience in the cosmetic and medical devices industries is a plus

Education And Experience

• Experience working in a regulated environment
• 5 + years of relevant experience
• 2 + years of management experience
• 4 year Bachelor's Degree in relevant field (preferred)