Microbiology Group Leader
On-sitePortage, Michigan, United States
Portage, Michigan, United StatesOn-siteFull TimeEnterprise
Full TimeEnterprise
Job Summary
Conduct semiannual performance reviews, interview applicants, and manage succession planning for assigned employees. Coordinate daily workflow, monitor time entries, and address performance issues while coaching team members on operational improvements. Independently act as technical lead for complex projects, audits, and escalated issues, driving investigations and proposing new LEAN initiatives. Develop and implement operational improvements, ensuring compliance with GMP/GLP, USP standards, and all state and federal regulations. Maintain training records and foster team morale through mentorship and leadership development.
Required Qualifications
- Applies GMP/GLP in all areas of responsibility, as appropriate
- Demonstrates and promotes the company vision
- Regular attendance and punctuality
- Ensure that the quality policy program is understood, implemented, and maintained at all levels of the organization; identify, prevent, or correct any departures from the quality system
- Perform work for both routine and non-routine work as specified by separate and applicable technical job description for individual
- Develop and implement operational improvements
- Supervise others in performing client's service requirements
- Coach, train, and develop others within the group with respect to their personal development and effective implementation of operational improvements
- Coordinate workflow and perform daily monitoring
- Conduct semiannual performance reviews, interview applicants, keep training records up to date for assigned employees, perform succession planning in preparation for growth
- Confront and address problems, concerns, and performance issues
- Coach and develop individual and team to maximize performance
- Foster motivation and morale
- Monitor and approve employees' time worked through time-entry system
- Support and promote company policies and procedures
- Expand self-awareness and develop leadership skills as defined; attend applicable leadership training based on identified needs
- Perform and/or assign other duties as requested to ensure smooth operation of department
- Perform all functions in support of and in compliance with all state and federal employment regulations
- Conducts all activities in a safe and efficient manner
- Must have experience with at least 2 of the following USP testing areas: USP <61>, <62>, and <60> for microbial limits testing; USP <51>, antimicrobial effectiveness testing; USP <71>, sterility testing; USP <85>, bacterial endotoxin testing
- Bachelor's degree in chemistry, biology, biochemistry or related degree concentration
- Extensive knowledge of aseptic techniques, microbial limits testing (MLT), endotoxin, sterility, environmental monitoring (EM), and microbial identification
- Strong understanding of applicable regulations, including USP, ICH, and Ph. Eur., related to microbial testing
- Experience in conducting laboratory investigations and supporting audit responses
- Independently act as technical lead in calls/audits for complex projects and start to act as lead for escalated issues
- Deep understanding of instrumental and/or analytical theory for all technical disciplines they oversee and provides support beyond own team
- Ability to independently drive complex investigations
- Comprehensive understanding of investigation impact on the business within department
- Highlight and provide justification for laboratory needs for current operation and future state through assessment of new techniques, technologies, instrumentation, space, KPI headcount, while monitoring and controlling cost
- Propose and drive new LEAN initiatives across department and division
- Record of mentoring any technical level staff. Advise and consult for group leader peers
- Build basic understanding of financial acumen
Desired Qualifications
- Candidates currently living within a commutable distance of Portage, MI are encouraged to apply
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