QC Testing Inspector II
Company: bioMerieux Inc.
Location: Durham
Posted on: May 31, 2025
Job Description:
Description Position Summary & Responsibilities:This position is in
a fast-paced, FDA regulated environment in the Medical
Devices/Diagnostics Industry. The Quality Control Testing Inspector
II will be in a key position in the Quality Control department by
facilitating sample and material inspection, result review and
communication, and testing continuity. Perform routine inspection
on material received and samples submitted to Quality Control
laboratories, and verify the results and communication of
testing.
Quality
Ensures all inspection and
documentation is completed in an accurate, thorough, and timely
manner.Ensures review of Quality Control documentation is done in
compliance with SOPs and is completed in an accurate and timely
manner.Maintains compliance with SOPs, GLP, GMP, and HSE
requirements.Prepares for regulatory, customer, and internal audits
of Quality Control areas.Preparation includes review of logbooks,
material expirations, component storage, etc.Provides input for
laboratory investigations.Documentation/Training
Enters data into the laboratory
information management system (LIMS) and applicable paper-based
data sheets. Assists with LIMS data entry to support LIMS
maintenance and validation activities.Ensures personal training is
maintained to current department processes and procedures.Safety
Appropriately utilizes PPE (Personal
Protective Equipment) as required to perform routine and
non-routine duties.Continuous Improvement
Participate in continuous improvement
activities.6S: Maintain the laboratory and other specific testing
areas of responsibility in a well-organized, clean, and tidy manner
in compliance with cGLP.Other DutiesPerforms additional job-related
duties as assigned by management.Education, Skills, & Experience:
High School Diploma with 2+ years of
experience working in a laboratory or regulated environment, GMP
preferredBachelor's degree with 0 years of relevant experience also
accepted. Degree in a Life Science field preferred.Prior laboratory
experience preferred. Experience with GMP documentation
preferred.
Keywords: bioMerieux Inc., Winston-Salem , QC Testing Inspector II, Other , Durham, North Carolina
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