Laboratory Production Technician

Meridian Bioscience, Inc.•Newtown, OH

About The Position

The Laboratory Production Technician is primarily responsible for producing in-vitro medical diagnostic products according to current manufacturing directions, SOPs, GMPs, and QSRs, meeting or exceeding quality specifications and production schedules while controlling costs. The role identifies and implements opportunities to improve manufacturing quality and efficiency and collaborates with Manufacturing, Quality Systems, Technical Support, Sales, and Marketing to support product quality and availability. The position performs laboratory production and support activities, including preparing buffers and reagents, conducting and interpreting in-process tests, supporting troubleshooting and root-cause investigations, testing incoming components, and maintaining adequate supplies of production materials. It requires accurate and timely documentation, adherence to regulatory and safety requirements, and prompt escalation of deviations. Depending on department assignment, the technician may assist with dispensing, packaging, and inspecting products; operate and maintain ISO-classified clean rooms and related equipment; or isolate, purify, and characterize proteins. Other duties include calibration activities, initiating quality-system records, training employees, and additional assigned work.

Requirements

Bachelor of Science degree or similar required.
Fundamental knowledge of biology and/or chemistry.
Knowledge of general laboratory techniques and the metric system.
Ability to communicate and interact with Manufacturing and Quality functions, inform supervisory personnel about project status, and follow scheduling and reporting procedures.
Excellent documentation skills and ability to complete cGMP documentation accurately and promptly.
Ability to read, understand, and follow company SOPs and guidelines.
Self-starter who is detail-oriented and organized, can prioritize and balance workloads and timelines, and can perform under pressure in a fast-paced environment.
Ability to maintain regular attendance and punctuality.
Ability to work outside normal work hours, including starting early, staying late, or working weekends, when needed to support department activities.
Ability to work independently and collaboratively with peers and colleagues in a cross-functional team setting.
Computer proficiency with Microsoft Office programs.

Nice To Haves

Experience in technical writing, including GMP documents, protocols, and reports.

Responsibilities

Produce in-vitro medical diagnostic products according to current manufacturing directions, SOPs, GMPs, and QSRs, meeting quality specifications and schedules.
Maintain accurate production records and complete timely documentation in compliance with cGMP and regulatory requirements; audit paperwork for missing or incomplete information.
Read, interpret, and follow production procedures, SOPs, GMPs, OSHA requirements, and quality-system requirements; apply aseptic technique.
Identify production deviations and promptly notify the appropriate Supervisor, Manager, or Director.
Identify and implement opportunities to improve procedures, products, manufacturing quality, and efficiency.
Prepare, test, and troubleshoot antigens, antisera, buffers, reagents, and other in-house-produced materials to support production needs.
Set up, perform, and interpret in-process testing of buffers, reagents, and components; assist with troubleshooting non-conforming results and determining root causes.
Monitor and requisition or initiate in-house production of raw materials and supplies; collect, wash, and store glassware.
Perform incoming testing of components as needed to verify acceptability before production use.
When assigned to Molecular, assist with dispensing, packaging, and inspecting reagents and products, and operate, maintain, and clean ISO-classified clean rooms and related equipment.
When assigned to Purification, isolate, purify, and characterize proteins from recombinant and natural sources.
Perform routine calibrations and complete calibration records in Blue Mountain as needed.
Initiate OOSs, deviations, and ECOs as needed with minimal supervision.
Train other employees as required and perform other duties as assigned.