Group Lead - Kit Assembly

About Meridian

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets

and distributes a broad range of innovative diagnostic products. We are dedicated to developing and

delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the

possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals

that help drive our vision. Our innovative culture will allow interested candidates to discover and create,

through collaboration, cutting edge solutions to tough problems.

Job Summary

The Group Lead is qualified to setup and complete all production operations required in their assigned

area and provides daily direction and standards for the team in an assigned work area. The Group

Lead is proficient in all computer programs that pertain to the individual work areas that are required in

the supervisor’s absence. This individual requires minimal supervision to perform his/her tasks and

has the capability to lead others in understanding and complying with all standard cGMP operating

procedures and guidelines set forth by management.

Key Duties

• Conduct daily team meetings and assign daily work assignments as directed by supervisor.
• Support the production supervisors to ensure smooth workflow, set up, on time production, and
• efficient and safe operation of the department.
• Drives continuous improvement of process and resources using Lean principals.
• Performs daily documentation review on the teams paperwork for corrections, missing, and/or incomplete information ensuring that it is neat, accurate and legible meeting Lot Release compliance specifications.
• Calibration of equipment as required per schedule.
• Effectively communicate with other departments to address production problems and all other cross-departmental issues. Follow escalation process to quickly address or determine resources needed to address production issues.
• Able to perform the entire scope of operations in their assigned area, including all materials management and document review duties and Formulator in Parapak.
• Performs tasks of other Operators, including inventory control and validations studies.
• Must be willing and able to help management in all efforts to foster and maintain a high level of morale and teamwork in their assigned area.
• Ensure prompt and accurate closure of manufacturing orders.
• Proactively monitors and plans cross training for business continuity as time allows.
• Identifies procedural deviations or abnormal components, takes appropriate steps to initiate deviation reports and notify area supervisor immediately.
• Other duties as assigned.

 

Department Specific Responsibilities:

o Molecular Manufacturing – Operate, maintain and clean ISO classified clean room and related equipment.

o Parapak – Back up Formulator, including checking, changing and documenting of recording charts and monitoring instruments (ie. Incubator, and DI water).

 

Qualifications

• H.S. Diploma or GED equivalent required.
• Six years prior experience in an FDA or other regulated manufacturing environment required

 

Preferred:

• Coordinates equipment scheduling/usage based on Materials Management master production schedule.
• Must have completed all training relevant to their Finished Goods Production area.
• Must have demonstrated strong leadership abilities and positive communication skills. Leads by example and builds strong team culture. Strong computer skills required.
• Must be a self-starter, detail oriented, organized and able to collaborate and perform under pressure in a fast-paced environment.
• Excellent interpersonal, organizational, written and oral communications skills.
• Ability to maintain regular attendance and punctuality requirements.
• Must be willing and able to work overtime and weekends to support production efforts as needed.

 

Physical Requirments:

• Ability to walk up and down several flights of stairs throughout the workday in a multi-location
• facility.
• Must have the ability to inspect, analyze and concentrate throughout the course of the work
• shift.
• Must be able to concentrate and problem solve routinely throughout the course of the work
• shift.
• Must have fine manual dexterity to ensure precise assembly of medical devices.
• Must have the ability to lift up to 25 pounds of supplies or finished product throughout the work
• shift.
• Ability to stand and/or sit for long periods, stoop, reach, bend, push and pull carts