Aseptic Manufacturing Quality Technician

STERIS•Saint Louis, MO

8d•Onsite

About The Position

The Quality Technician is responsible for supporting site quality functions and ensuring compliance with applicable regulatory and quality standards, including ISO 13485, MDSAP, FDA, and EU MDR requirements. This role primarily supports aseptic manufacturing operations through in-process inspections, environmental monitoring, quality testing, and product acceptance activities. The Quality Technician assists with identifying and documenting nonconformances, conducting investigations, reviewing manufacturing records, supporting product release activities, and maintaining calibration and monitoring programs to ensure product quality and compliance.

Requirements

HS Diploma/GED + three (3) years of experience in a manufacturing or repair environment or other technical production tasks.
Associates + Minimum of one (1) year of experience in a manufacturing or repair environment or other technical production tasks
Experience with mathematical skills including ratios, proportions and basic algebra.
Ability to work in a fast-paced environment with strict deadlines.
generate detailed, high-quality documentation.
Ability to: work with others in analyzing and solving technical problems.
work in a professional manner to support team actions.
effectively manages work tasks.
PC experience and familiarity of common desktop applications including Excel and Word.
Must pass gowning certification through STERIS.

Nice To Haves

Previous work expereince in a regulated industry, preferably: ISO 13485, FDA or similar.
Experience working in an environment with aseptic gowning and/or current certification.
Strong GDP (good documenting processes) in a 5S/Lean manufacturing environment.
Experience cross training between aseptic and chemical environment.

Responsibilities

Assists in production line Quality investigations and associated problem-solving activities.
May coordinate and conduct in-process and final QC product acceptance testing, depending on facility.
Investigates production line stoppages to identify corrective actions.
Identifies and documents product and process non-conformances.
Participates on a Material Review Board to review and process non conformance reports.
Reviews DHR’s and supports batch record release.
Enters and retrieves Quality data from local and global systems.
Performs site calibration activities and recordkeeping.
Executes environmental monitoring processes and recordkeeping.
Verifies calculations, dose ranges, dosimeter placements and special instructions prior to processing and part of final product release.
Will make decisions regarding the acceptability of raw materials, work in process and finished products.
Identify opportunities for improvement and non-conformances.
Propose potential solutions to site management and work with the appropriate individuals to implement the agreed upon improvement.