Laboratory Production Technician

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 Laboratory 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 opportunities, 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.

Key Duties

• 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 documentation 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:
  • Willingness to assist with dispensing, packaging, and inspecting reagents and products in accordance with manufacturing directions following current SOPs, GMPs, and QSRs as needed.
  • 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 as assigned.

Qualifications

• Bachelor’s of Science degree or similar required.
• Fundamental knowledge in biology and/or chemistry.
• 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.
• 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
• When necessary, 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.