A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions that detect disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 5,000 team members across 12 sites or subsidiaries, including Salt Lake City based BioFire Diagnostics. We believe in the power of diagnostics and bioMérieux sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health across the globe. Come be a part of our mission to help save lives.
- The Service and Distribution Group Lead position is responsible for the following areas
- Manufacturing Service and Support Teams
- Warehouse functions within the Distribution Team
- May provide indirect leadership for other teams as assigned
- Position responsibilities include
- Following regulatory and customer requirements.
- The development of internal candidates by providing expanded responsibilities in relation to team leadership, including personnel performance management and accountability for team performance metrics and projects
- The ability to effectively lead quality and/or safety initiatives that are critical to the department’s ability to improve manufacturing processes, increase product quality, improve departmental productivity/efficiency and ensure employee safety
- The reduction of manufacturing costs/scrap
- Manufacturing Service and Support
- Coordinate department requests for equipment or personnel support that impact manufacturing operations.
- Oversee and assist Technicians in management of daily activities including scheduling cleaning activities.
- Maintain an efficient and effective workforce.
- Warehouse / Distribution Support
- Logistics / packaging
- Domestic and international shipping
- Material handling
- Receiving and inspection support
- Interaction and collaboration with external vendors and transportation carriers.
- Contribute to team goal development, status tracking and communication through the PMP (Performance Management Program) process. Communicate with other departments (i.e. Materials Management, Production Operations, and Quality Control) as needed to ensure the timely and efficient production of all of our customer requirements.
- Conduct meetings (team and/or safety) as needed, keep records/documentation of information discussed.
- Perform other duties as assigned by Management.
Leadership / Employee Development
- Provide performance feedback coaching and development for Team Leads and/or team members.
- Complete formal performance evaluations for all direct reports.
- Inspire and motivate production and distribution teams to achieve top performance.
- Promote self-growth and internal development within the team.
- Demonstrate and work towards developing the following attributes:
- Inspire, motivate, and guide others toward goal accomplishments. Consistently develop and sustain cooperative working relationships. Encourage and facilitate cooperation within the organization and with customer groups; foster commitment, team spirit, pride, and trust. Develop leadership in others through coaching, mentoring and guiding.
- Convey goals and objectives clearly and in a compelling manner; listen effectively and clarify information as needed; interpret verbal and non-verbal messages that others communicate; produce clear status reports; communicates tactfully and candidly.
- Lead by example.
Documentation & Training Compliance
- Utilize a variety of software systems to support daily work activities (i.e. TrackWise, LiveLink/DocLink, SAP, Compliance Wire, etc.).
- Ensure overall team training compliance is maintained current for processes and procedures relevant to all activities and coordinate cross training among roles to create staffing flexibility and increased depth.
- Ensure that Manufacturing batch records and other documentation are prepared, completed and stored at the highest standards according to company policies and procedures to support manufacturing, maintenance of device history records, logs/logbooks and training requirements consistent with cGMP, ISO, and all applicable regulatory policies/regulations.
- Lead and promote continuous improvement through team and individual initiatives.
- Identify areas of deficiency and implement practices to improve employee safety and to reduce the cost incurred through excessive scrap, poor workflow/process design and others.
- Lead project teams and/or serve as a project team member to reduce scrap, improve product quality, decrease operational costs, and increase departmental efficiency/productivity.
- Serve as change agent by driving the required cultural transformation and the adoption of successful process improvement practices.
Quality / Manufacturing Compliance
- Coordinate with the shift Manufacturing Compliance team member(s) to mitigate errors via the Right The First Time (RTF) initiatives
- Ensure Quality Assurance is communicated to the team for minimal deviations and error free performance.
- Maintaining the BacT/ALERT manufacturing operation so that it is GMP compliant and meets all regulatory requirements.
- Review documentation to support manufacturing, maintenance history records and training requirements that adhere to all applicable procedures and regulations.
- Ensure the most recent information related to manufacturing and maintenance is communicated and/or documented for compliance, history, and reliability.
- Assist with and/or lead Manufacturing investigations, CAPA actions, In-Process Events (IPEs) and other process equipment related quality concerns.
- Ensure that Manufacturing batch records and other documentation are prepared, completed and stored at the highest standards according to company policies and procedures to support manufacturing, maintenance of device history records, logs/logbooks and training requirements consistent with cGMP, ISO, and all other applicable policies and regulations.
Health Safety and Environmental
- Ensure employees are following all Health, Safety and Environmental SOP’s
- Manage all safety matters including audits, incident reporting & investigation, training, OSHA and ISO 14001/45001 compliance
- Perform, delegate and monitor daily operations, including line inspections, operating manufacturing equipment and set-up and tear down activities.
Studies, Experience, Skills and Qualifications:
- High School Diploma or GED Required
- A minimum of 5 years in a GMP production/operations environment and a minimum of 3 years people management and/or supervisory experience is required.
- Distribution and warehousing experience is desired.
- Demonstrated proficiency in the operation of manual, semi-automated and fully automated manufacturing systems
- Flexibility around changing priorities
- Demonstrated experience of working independently
- Distribution and warehousing experience
- Prior BacT/ALERT Leadership
- Experience in a regulated environment required
- Knowledge of FDA regulations
- Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) is desired and ISO 14001/45001
- Clean-room experience
- Experience in scheduling activities cross functionally in a high pace manufacturing environment
- Ability to regularly climb stairs to perform work
- Ability to work overtime as required to support a 24/7 production operation
- May be exposed to and require the handling of chemicals, antibiotics and/or hazardous materials
- May be exposed to strong odors incurred during media production or other operations
- Job Duties are performed wearing various types of PPE and cGMP which include but are not limited to a hairnet, beard cover, safety glasses, safety shoes, hearing protection, gloves, PAPR, face mask and lab coat. Make-up and jewelry are prohibited in certain areas of Manufacturing.
Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. Our Group offers numerous possibilities: so come and join the 13,000 bioMérieux team members who already identify with these values!
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.