QC Inspector

About You:

In this technical role, the QC inspector will be responsible for performing Quality Control processes for incoming materials as well as in-house fabricated components and assemblies to confirm the conformance of the product to the specifications. Working directly with the manufacturing team, this role will provide input on methods for inspection and testing as well as perform record review and documentation of inspection and test results. Duties include, but are not limited to, assisting with the development of incoming, in-process and final inspection processes, criteria, and records; performing visual inspections and/or testing on samples of batches of incoming, in-process and finished product; reviewing and approving batch records as well as assisting in the development of work instructions for these activities.

What you'll do:

• Execute Quality Control activities in support of reagent and consumable manufacturing, performing in-process sampling inspection, where applicable, as well as final acceptance testing and batch record review and acceptance including reviewing engineering drawings and/or specifications to confirm compliance.
• Collaborate with Engineering, Manufacturing, Process Development and Assay Development teams to improve inspection and test methods for incoming raw materials, in-process assemblies, and reagent formulations as well as final acceptance of products (reagents and consumables).
• Support the Manufacturing team by performing final QC acceptance and release of batches of consumable assemblies, for use in Assay Development as well as clinical studies.
• Confirm that all equipment used to measure has been calibrated; such as calipers and micrometers.
• Follow GDP and GMP processes to ensure that acceptance activities are completed appropriately, and the results documented accurately.
• Participate in investigations and root cause analysis activities as well as provide summary information on inspection results and trends to drive continuous improvement activities.
• Create work instructions and record forms for QC activities.
  
  

What you need:

• Associate’s degree in a technical field;
• 1-2 years of industry experience with knowledge and experience in Quality Control in a cGMP environment;
• Familiar with Quality Control processes related to the manufacture of reagents and consumables for IVDs;
• Experience with use of common inspection tools such as calipers, micrometers, depth gauge, optical comparators, etc;
• Excellent organizational skills and attention to detail;
• Clear communication skills, both verbal and written;
• Demonstrated analytical and reporting skills;
• Ability to manage multiple priorities and activities;
• Proven ability to collaborate cross-functionally and participate on multi-disciplinary teams.
  
  

What would excite us:

• Experience with lean and six sigma methodologies and their use in manufacturing;
• Prior experience with single use cartridge assembly and lyophilization processes would be welcomed;
• An appreciation of puns!