Quality Control Technician

Quality Control Technician

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.

• 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.

• Understands that product meeting specification is what protects the patient and the customer.
• Understands QC's role within the manufacturing process.
• Understands, at a working level, quality standards like FDA 21 CFR 820 and ISO 13485.

• Takes ownership and demonstrates enthusiasm in their role.
• Takes ownership of right-first time results and complete, accurate documentation.
• Actively strives to be better and to learn new things as they relate to their role and IMMY.
• Identifies knowledge gaps and proactively works to close those gaps.
• Enjoys precise, repeatable work and takes pride in data integrity.

• High attention to detail and strong organizational skills.
• Comfortable performing repetitive tasks.
• Can handle the stress and pressure of their role.
• Proficient with general laboratory equipment.

• 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.

• Experience working in a laboratory and use of general lab equipment including pipettes and balances.

• Must meet all requirements of the Quality Control Technician I.
• QC Tech II: 1+ years of relevant work experience…