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Meridian Bioscience Senior Operator in North Billerica, Massachusetts

Meridian is a fully integrated life sciences company that manufactures, markets and distributes a broad range of innovative diagnostic test kits, purified reagents and related products and offers biopharmaceutical enabling technologies.

The Senior Operator retains the knowledge of the Assembler and Operator positions and is the go-to person of the areas of responsibility. This employee will demonstrate leadership qualities and should / will be proficiently cross trained in other functional areas. This employee will have become proficient in all computer programs that pertain to the individual work areas that are required in the supervisor’s absence. This individual will require minimal supervision to perform his/her tasks and have the capability to lead others in understanding and complying with all standard cGMP operating procedures and guidelines set forth by management.

General Responsibilities (but not limited to):

  • All Operator responsibilities.

  • Is “A” go to person for routine and mechanical aptitude in areas of assignment.

  • Lead Assembler and Operator positions in the absence of Group Leader / Supervisor / Manager.

  • Must be able to troubleshoot equipment and automation in the respective department with the support of Maintenance and Engineering.

  • Coach / train others in performing morning calibrations and routine process monitoring as needed.

  • Communicates clearly and effectively with department peers, lab production associates, and support departments as well as Supervisors, Managers, and Directors.

  • Document training for other Assemblers and Operators with minimal supervision.

  • Is proficient in using all computer programs necessary for the required department.

  • Set up and perform validation studies and assist in product transfer and design control processes as needed.

  • Minimal supervisory attention is required at this level.

  • Work towards becomming a subject matter expert in the areas defined by management.

  • Assist management in adhering to the master production schedule and identify bottlenecks.

  • Coach and train Assemblers and Operators in the ability to perform all phases of procedure operation.

  • Prompt and accurate closure of manufacturing orders and trending if where applicable.

  • Other duties as required.

Job-Specific Responsibilities (but not limited to):

Kit Assembly

  • Perform all assembler/operator level duties

  • Can perform troubleshooting and PM’s on equipment with limited assistance from supervisor or manager

Sensor Assembly

  • Perform all assembler/operator level duties

  • Ability to be a “go-to” person for others whom may be having difficulties setting up or operating a machine.

  • Ability to plan manufacturing duties efficiently within and area.

  • Can perform troubleshooting and PM’s on machines with limited assistance from supervisor, engineer or manager

Formulation

  • Formulation duties include weighing powders, dissolving powders using mixing, heating/cooling methods, adjusting solution molarity or pH, filtration, etc.

  • Perform formulation procedures and maintain batch records for all reagents produced including but not limited to: final formulations and sub-assembly formulations.

Analyzer Assembly & Test

  • Perform all assembler/operator level duties

  • Responsible for building, testing and troubleshooting of mechanical and electrical assemblies and generate related documentation, Device History Records (DHR’s)

  • Initiate and submit minor design change proposals to the procedures, components, assemblies and subassemblies of the instruments to the Engineering team for review and implementation.

  • Assist the R&D and the Engineering teams in the assembly of a wide variety of instrument and subassembly prototypes.

  • Specify hardware changes or special hardware required by the changes in instrument design or assembly methods.

  • Assist in the development of manufacturing procedures and tools for the new products and provide support and training to the Production team for the assembly of products as necessary.

  • Assist management and engineering with compiling quality and production data required for business reviews.

QUALIFICATIONS:

Education/Experience:

  • High School Diploma or general education degree (GED) required.

  • A minimum of 4 years prior manufacturing and/or Assembly/Operator experience required.

  • A minimum of 3+ years prior experience in a FDA regulated production environment preferred.

Skills, Specialized Knowledge and Abilities:

  • Must be able to perform job duties with minimal supervision.

  • Excellent interpersonal, organizational, written and oral communications skills.

  • Excellent problem solving and troubleshooting skills.

  • Demonstrated required level of Master Control use and understanding.

  • Senior Operator is fully competent in one core department and has working knowledge of job specific duties in other departments

Requirements (Physical, Mental, Environmental Demands):

  • 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 25-50 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 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)

  • Must be able to identify and differentiate color and color changes on diagnostic devices and device components.

  • Must be able to read, navigate, and operate controls systems screens and written documents throughout the course of the workday.

  • Must be able to detect audible and or visual alarms.

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: 101 Billerica Ave

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