Quality Control Technician

IMMY•Norman, OK

About The Position

The Quality Control (QC) Technician will perform equipment calibrations, product inspections, and assay testing to ensure only high-quality diagnostics are released to IMMY customers. This technician must have a high attention to detail, be extremely organized, handle tight deadlines, and must be comfortable performing repetitive tasks. The role requires understanding that product meeting specification protects the patient and customer, understanding QC's role within the manufacturing process, and a working-level understanding of quality standards like FDA 21 CFR 820 and ISO 13485. The ideal candidate takes ownership and demonstrates enthusiasm, strives to be better and learn new things, identifies and closes knowledge gaps, and enjoys precise, repeatable work with pride in data integrity. This role demands a high attention to detail, strong organizational skills, comfort with repetitive tasks, ability to handle stress and pressure, and proficiency with general laboratory equipment.

Requirements

Bachelor’s degree in microbiology, biology, biochemistry, chemistry, engineering or related field or a combination of other education/job related experience.
Skilled in Microsoft Applications including Word and Excel.
Must have professional behavior; excellent verbal, interpersonal, and written communication skills; extremely organized with a high attention to detail; and able to work independently and as part of a team.
Must be comfortable performing repetitive tasks while maintaining quality.
Must meet all requirements of the Quality Control Technician I.

Nice To Haves

Experience working in a laboratory and use of general lab equipment including pipettes and balances.
QC Tech II: 1+ years of relevant work experience and/or working in an established ISO 13485 and FDA QSR environment.
QC Tech III: 3+ years of relevant work experience and/or working in an established ISO 13485 and FDA QSR environment.

Responsibilities

Perform QC testing and inspection on all products
Perform routine laboratory quality control testing, inspections, and analysis of critical items, raw materials, in-process items, and finished goods for all IMMY products.
Collaborate with senior team members to interpret test results, compare them to established specifications and control limits, and make recommendations for product release or rejection.
Organize and maintain data generated from quality control testing and ensure that quality documentation and records are compliant with internal requirements as well as applicable regulatory requirements.
Update and trend QC related data to ensure there have been no shifts in the manufacturing of products.
Ensure all specifications are met during the manufacturing and quality control process.
Support laboratory proficiency testing and post-market surveillance testing
Perform laboratory proficiency testing on IMMY products and document results.
Maintain end of shelf-life databases including inventory of materials and documentation of results.
Perform reliability testing of assigned products.
Perform quality system monitoring and measurement activities
Perform monthly, quarterly, and yearly calibrations of laboratory equipment (pipettes, balances, microplate readers, etc.) and all required monitoring and measurement testing (bioburdens, residue tests, conductivity, etc.).
Perform general lab maintenance including maintenance of monitoring equipment (pipettes, multichannels, repeaters, balances, etc.), general lab organization, and lab coat laundering.
Manufacture QC specimens and reference materials
Perform testing, manufacturing, and packaging of QC specimens, reference materials, and QC kits.
Inventory and maintain specimen databases including the check in and check out process of specimens.
Frequent use of Microsoft Office applications, quality management software, and ERP software.
Must comply with all company policies, procedures, internal and external quality standards, and relevant regulatory standards; must remain up to date on Quality Regulations and ISO Standards.
Other duties as assigned.