Job Title: Quality Control Technician

Interested candidates can send updated resumes to Mamcdonough @actalentservices .com or text Marisa at 330. 397. 1302 to set up a phone interview!

Job Description

The individual will work primarily in the Quality Control Laboratory to support the testing and analysis of cGMP produced viral vectors and cells. Collaboration with the QC manager and senior QC staff is crucial to cultivate and enact strategic direction to the GMP area. The role involves running sample assays five nights a week, and performing proper operation, calibration, validation, cleaning, and maintenance of QC lab equipment.

Responsibilities

• Perform QC methods, develop methods, analyze microbiological environmental monitoring samples.
• Write and revise SOPs, maintain and monitor equipment, and manage QC and production supplies.
• Periodically clean the clean room facility and assist with manufacturing of viral vector products.
• Operate within the Quality Management System applicable to the manufacture of phase-appropriate material.
• Ensure all product samples are adequately labeled and documented.
• Account for product allocation across sample requirements and storage conditions.
• Evaluate sample management processes, identify gaps, and implement improvements.
• Complete, review, file, and archive documentation according to SOPs.
• Maintain compliance with regulatory requirements for cellular and gene therapy products.
• Perform tasks according to established policies, procedures, and techniques, under close supervision.
• Work in a diverse and collaborative team environment, utilizing clear communication for high productivity.

Essential Skills

• Degree in Biology or other life science field.
• Experience in aseptic technique, PCR, and ELISA procedures.
• Understanding of regulatory and documentation constraints in a GMP environment.

Additional Skills & Qualifications

• Experience from GMP manufacturing or strong documentation experience is highly preferred.

Work Environment

This role is based in a quickly growing company building two new sites in Columbus, Ohio, featuring state-of-the-art clean rooms and equipment. The work involves cross-functional teams. The shift is from Monday to Friday, 2 PM to 10:30 PM, with flexibility needed to occasionally work past 10:30 PM depending on sample testing requirements.