Lab Production Technician - Meridian Bioscience, Inc.

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.

The Production Technician has primary responsibility for production of in-vitro medical diagnostic products in accordance with current manufacturing directions, SOPs, GMPs, and QSR to meet or exceed quality specifications on schedule at or below standard costs. Identify areas, formulate and execute plans for manufacturing process quality and efficiency improvements. Work in collaboration with Manufacturing, Quality Systems, Technical Support, Sales and Marketing to ensure product quality and availability.

Tasks and Responsibilites: 

• Maintain accurate records in accordance with current SOPs and cGMP.
• Read, understand, and comply with Good Manufacturing Practices and Standard Operating Procedures.
• Understand and apply the concepts of aseptic technique.
• Correctly read and interpret detailed production procedures.
• Comply with all OSHA and Quality system requirements.
• Accurate, timely and complete documentation in conformance with regulatory policies and standards to meet quality requirements.
• Makes and records observations as needed and completes all necessary calculations in compliance with GMP requirements.
• Audit own paperwork daily for corrections, missing, and/or incomplete information.
• Immediately identify any deviation from production procedures and notify the appropriate Supervisor/Manager/Director.

• Recognize and evaluate ways to improve procedures and products. Ensure an adequate supply of antigens, antisera and other in-house produced materials to meet production needs (prepare, test, trouble-shoot).
• Perform technical procedures including preparation of buffers/reagents in accordance with manufacturing directions following current SOPs, GMPs, and QSRs.
• Set up, perform, and accurately interpret in-process testing of buffers/reagents/components.  Assist in troubleshooting non-conforming results to determine root cause.
• Conducts laboratory support functions, such as monitor and requisition or initiate in-house production of raw materials and supplies required to meet production schedules and collecting/washing/storing glassware.
• Complete incoming testing analysis for components where needed to ensure acceptability per quality guidelines prior to use in production.
• When working in the Molecular department:
  • Dispense, package, and inspect reagents and products in accordance with manufacturing directions following current SOPs, GMPs, and QSRs.
  • Operate, maintain and clean ISO Classified clean rooms and related equipment in accordance with SOPs
• When working in Purification department
  • Responsible for the isolation, purification, and characterization of proteins from recombinant and natural sources.
• Perform routine calibrations and complete calibration records in Blue Mountain, as needed.
• Initiate OOS's, Deviations, and ECO's as needed with minimal supervision.
• Train other employees as required.

Other Duties: 

• Ability to walk up and down several flights of stairs throughout the work day in a multi-location facility
• Ability to lift, on a daily basis, up to 40 lbs. of supplies or finished product
• Must be able to wear personal protective equipment for extended periods of time in a cleanroom environment (ex. Latex or nitrile gloves, face shields, safety glasses, hairnets, shoe coverings, full-face respirator, full body gowns, etc.) 
• Must be able to adhere to applicable bio-safety practices when on the manufacturing floor or in laboratories
• Must be able to differentiate colors in product.
• Must be able to analyze and interpret data
• Must be able to concentrate and problem solve routinely throughout the course of the work shift.
• Must be able to read controls systems screens and written documents throughout the course of the workday.
• Must be able to detect audible alarms.
• Must be a non-smoker in order to perform work within a molecular or cleanroom environment.
• Must be able to concentrate and problem solve routinely throughout the course of the work shift.
• Ability to stand and sit for long periods of time, stop, reach, push and pull equipment throughout the course of the work shift.

Minimum Education or Equivalent Experience Required/Preferred

• Bachelor’s degree in Molecular Biology, Microbiology, Biochemistry, or similar degree required.
• Experience in a FDA-regulated manufacturing, or laboratory environment is desirable.
• Previous course work in immunology, microbiology cell biology, biochemistry, virology and chemistry is desirable.

Competencies Required or preferred

• Preferred skills include Cell culture, Virus culture, Bacteriology, Protein purification and conjugation, Microscopy, experience with Laboratory equipment including Spectrophotometer pH meter, centrifuges, column chromatography, and performing diagnostic assays.
• Communication skills include: ability to interact with Manufacturing and Quality function; clearly inform supervisory personnel regarding status of projects; and establish and follow target date scheduling and reporting procedures.
• Aseptic technique, general laboratory techniques and metric system knowledge required.
• Excellent documentation skills as required by cGMPs on a timely basis.
• Ability to read, understand and follow all company SOPs and guidelines.
• 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
• Must be able to work hours outside of the normal work day (start early, stay late or weekends) to support department activities.
• Must be able to work independently as well as collaboratively in a team setting with peers and colleagues in a cross functional setting.
• Computer proficient in Microsoft Office programs. Experience in technical writing (GMP documents, protocols, reports, etc) a plus.

*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. (USA Only)*