Meridian Bioscience Group Lead in Cincinnati, Ohio
The Group Leader will have the responsibility for providing daily direction and setting standards for the Assemblers and Operators in their area. This employee 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. Additionally, this role prepare and assist in formulation, dispensing, packaging and labeling of FDA regulated medical devices in a fast-paced and results-oriented environment, meeting quality standards in accordance with cost, schedule and all standard cGMP operating procedures and guidelines. This person shall possess the skills, appropriate knowledge and ability to direct the entire Para Pak operation in the manufacturing of these products and shall provide support as a backup formulator. The Para-Pak Backup Formulator must possess the skills to independently perform tasks that require several independent steps and evaluations to formulate all the necessary batches when the formulator is not available.
Direct the day-to-day operation of our filling and packing department.
Ability to perform all phases of paperwork, which include reading and understanding standard operating procedures and how they are related to the operation. Troubleshoot all production equipment.
Effectively plan and assign work to subordinate co-workers based on the production schedule.
Perform routine monitoring during the shift. Write and/or modify department related documents as required. Set up and follow validation protocols as written.
Assist and train Production Associates as time and needs allow.
Assist in the dispensing, capping of reagents in a controlled environment Maintain accurate records in accordance with current SOPs and CGMPs.
Backup Formulator: assume responsibility when regular formulator is off
Calibration of balances, pH meters and other equipment required for manufacturing processes.
Setup and change over tabletop dispensers, labelers and counting balances. Complete all sampling and production documentation
High school diploma or general education degree (GED) is required.
Prior manufacturing and/or assembly experience required
Training in formulation is required.
Minimum of three years experience in a FDA regulated production environment preferred.
Prior experience with GMPs and/or sanitation SOPs highly desired.
Skills, Specialized Knowledge and Abilities:
Ability to read, understand and follow all company Standard Operating Procedures (SOPs) and guidelines.
Must have basic math skills and be able to perform step by step arithmetic calculations.
Must be a self starter, detail oriented, organized and be able to perform under pressure in a fast-paced environment.
Excellent interpersonal, organizational, written and oral communication skills.
Ability to maintain regular attendance and punctuality requirements.
Working knowledge of handling Hazardous/Non Hazardous Materials preferred
Must be able to work hours outside of the regularly scheduled shift, overtime and weekends to support production efforts as needed.
Must be able to work independently as well as collaboratively in a team setting with peers and colleagues in a cross functional setting.
Excellent problem solving and troubleshooting skills.
Requirements (Physical, Mental, Environmental Demands):
Ability to walk up and down several flights of stairs throughout the work day 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 110 pounds of supplies and transport 570 pound drums on and off the scale throughout the work shift.
Ability to stand and/or sit for long periods, stoop, reach, bend, push and pull carts and hand jacks throughout the course of the work shift.
Ability to wear all required personal protective equipment (lab coat, safety glasses, hair coverings, latex or nitrile gloves, full face respirator)
Must be able to identify and differentiate color on diagnostic devices or components.
Must be able to distinguish color changes in device components.
Must be able to read controls systems screens and written documents throughout the course of the workday.
We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
Company: Meridian Bioscience, Inc.
External Company URL: www.meridianbioscience.com
Street: 3471 River Hills Drive