Operator, Molecular Manufacturing Jobs

The Molecular Operator has primary responsibility for dispensing of in-vitro medical diagnostic reagents in accordance with current manufacturing directions, SOPs, GMPs, and QSR to meet or exceed quality specifications on schedule at or below standard costs.

GENERAL RESPONSIBILITIES:

• Learn how to troubleshoot equipment and automation with the support of Maintenance and OCS.
• Other duties as assigned.
• Work independently and assist Assemblers.
• Must be able to work independently as well as collaboratively in a team setting with peers in a cross departmental setting.
• Assist in completion of calibrations and routine process monitoring as needed.
• Monitor and requisition inventory for the purpose of fulfilling production needs as needed.
• All general responsibilities for a Molecular Assembler.
• Become proficient in using all computer programs necessary for the required department.
• Train other employees as required.
• Ability to develop mechanical aptitude in areas of assignment.

JOB-SPECIFIC RESPONSIBILITIES:

• Correctly identify all abnormal components and notify the Group Leader or Supervisor.
• Dispense reagents as needed.
• Conduct in process inspections to assure products meet quality specifications.
• Maintain sufficient inventories of supplies and materials necessary to dispense, tip, and cap diagnostic products.
• Perform routine monitoring/cleaning required in the Clean Rooms and/or other production environments.
• Operate, maintain and clean ISO Classified clean rooms and related equipment in accordance with SOPs.
• Clean and sterilize glassware and production materials as needed.
• Package dispensed molecular reagents as needed.
• Operate and maintain automated production equipment.
• Aid in dispensing of reagents (tip, cap, and label product).

QUALIFICATIONS:

Education/Experience: 

• High school diploma or general education degree (GED) required.
• Previous laboratory training and/or medical or science related courses helpful.
• 2+ years’ experience in a FDA or other regulated manufacturing, laboratory environment, cleanroom environment experience is preferred. 
• Previous experience operating automated equipment and/or assembly experience is preferred.

Skills, Specialized Knowledge and Abilities:

• Excellent interpersonal, organizational, written and oral communications skills along with the ability to interact with Manufacturing and Quality.
• Must be able to work hours outside of the normal work day (start early, stay late or weekends) to support department activities.
• Excellent problem solving and troubleshooting skills.
• Must have basic math skills and be able to perform step by step arithmetic calculations.
• Excellent documentation skills as required by cGMPs on a timely basis.
• Basic computer skills required (Word, Excel).
• Must be a self-starter, detail oriented, organized, prioritize and balance workloads and timelines and be able to perform under pressure in a fast-paced environment.
• Ability to maintain regular attendance and punctuality requirements.
• Ability to read, understand and follow all company SOPs and guidelines.
• Must be able to work independently as well as collaboratively in a team setting with peers and colleagues in a cross functional setting.
• Experience with the Metric System preferred.

Requirements (Physical, Mental, Environmental Demands):

• Must have the ability to lift up to 25-50 pounds of supplies or finished product throughout the work shift.
• Must be able to identify and differentiate color on diagnostic devices or components.
• Must be able to wear full body gown protective equipment for extended periods of time in a cleanroom environment (coveralls, surgical mask, safety glasses, hairnet, shoe covers).
• Must be able to concentrate and problem solve routinely throughout the course of the work shift.
• Must be able to detect audible alarms.
• 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.
• Must be able to distinguish color changes in device components.
• Must have fine manual dexterity to ensure precise assembly of medical devices - including the ability to tighten caps in a repetitive manner.
• Must be able to read controls systems screens and written documents throughout the course of the workday.
• Must have the ability to inspect, analyze and concentrate throughout the course of the work shift.
• Must be able to work in a tobacco free environment; strongly preferred
• Must be able to adhere to applicable bio-safety practices when on the manufacturing floor or in laboratories.
• Ability to walk up and down several flights of stairs throughout the work day in a multi-location facility.
• Must be able to wear a full-face respirator for extended periods of time.

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.