Laboratory Production Technician

Meridian Bioscience•Cincinnati, 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 QSR requirements, meeting quality specifications and production schedules while controlling costs. The role also identifies and carries out 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 and production procedures, prepares and tests materials, supports troubleshooting and incoming component testing, and maintains accurate, complete documentation in accordance with regulatory requirements. Duties vary by department: Molecular work may include dispensing, packaging, and inspecting products and maintaining ISO-classified clean rooms; Purification work includes isolating, purifying, and characterizing proteins.

Requirements

Bachelor of Science degree or similar.
Fundamental knowledge of biology and/or chemistry.
General laboratory techniques and knowledge of the metric system.
Excellent, timely documentation skills consistent with cGMP requirements.
Ability to read, understand, and follow company SOPs and guidelines.
Ability to interact with Manufacturing and Quality functions, clearly communicate project status to supervisory personnel, and follow target-date scheduling and reporting procedures.
Self-starter with attention to detail, organization, and the ability to prioritize and balance workloads and timelines while working under pressure in a fast-paced environment.
Ability to maintain regular attendance and punctuality.
Ability to work outside normal work hours, including early starts, late stays, or weekends, when needed to support department activities.
Ability to work independently and collaboratively with peers and colleagues in cross-functional teams.
Proficiency with Microsoft Office programs.

Nice To Haves

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

Responsibilities

Maintain accurate records in accordance with current SOPs and cGMP requirements, and audit paperwork for corrections or missing and incomplete information.
Read, understand, and comply with Good Manufacturing Practices, Standard Operating Procedures, OSHA requirements, and quality system requirements.
Apply aseptic technique and correctly interpret detailed production procedures.
Make and record observations and complete required documentation in accordance with GMP and regulatory policies and standards.
Identify deviations from production procedures and promptly notify the appropriate Supervisor, Manager, or Director.
Recognize opportunities to improve procedures and products and formulate and execute manufacturing process quality and efficiency improvements.
Prepare, test, and troubleshoot antigens, antisera, and other in-house-produced materials to support production needs.
Perform technical procedures, including preparing buffers and reagents, according to manufacturing directions and applicable SOPs, GMPs, and QSRs.
Set up, perform, and accurately interpret in-process testing of buffers, reagents, and components.
Assist with troubleshooting non-conforming results to determine root cause.
Monitor and requisition supplies or initiate in-house production of raw materials needed to meet production schedules, and collect, wash, and store glassware.
Perform incoming testing analysis of components when needed to confirm acceptability before production use.
In the Molecular department, assist with dispensing, packaging, and inspecting reagents and products as needed.
Operate, maintain, and clean ISO-classified clean rooms and related equipment according to SOPs.
In the Purification department, 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.