QC Technician

About You:

In this technical role, the QC technician will be responsible for execution of Quality Control processes for incoming materials, in-process samples as well as final product to confirm the conformance of the product to the specifications. Working directly with the manufacturing team, this role will help identify critical to quality characteristics, perform inspection and testing as well as record review and documentation of inspection and test results.

Duties include, but are not limited to, participating in the development of incoming, in-process and final inspection processes and criteria; performing final acceptance inspections and/or testing on samples of batches of finished product; reviewing and approving device history and batch production records as well as assisting with the development of work instructions for these activities.

• Execute Quality Control activities in support of reagent, consumable and instrument manufacturing, performing in-process sampling inspection, where applicable, as well as final acceptance testing and batch record review and acceptance.
• As a Quality Control Subject Matter Expert, participate in manufacturing process development activities, providing input on the best methods to confirm quality and consistency throughout the assembly process.
• Support the Manufacturing team by performing final QC review of the documentation for instruments, modules and batches of consumable assemblies.
• Execute verification activities with the Manufacturing teams to confirm effective line clearance between production batches or builds.
• Participate in the establishment of appropriate QC processes and controls to confirm consistency and quality of instrument, module, reagent and consumable manufacturing from prototype through production scale-up.
• Utilize your knowledge and experience to follow and recommend improvements to cGMP manufacturing processes and operations.
• Assist Supply Chain Management with supplier qualification activities and monitoring supplier performance by tracking and maintaining metrics around incoming material quality.
• Participate in process FMEAs and risk identification as well as providing input to countermeasures.
• Follow work instructions and complete record forms for QC activities.
• Participate in the Materials Review Board, providing input on NCRs and OOS to enable proper disposition.
• Assist in the execution of, and confirm the successful execution of MRB dispositions of Non-conforming materials.
• Provide data in support of investigations for Non-Conformances, Out-of-Specification (OOS) investigations and CAPA actions related to manufactured product and manufacturing processes.

• Bachelor’s degree in a technical field
• 2-5 years of industry experience with specialized knowledge and experience in Quality Assurance in a cGMP environment
• Familiar with Quality Assurance processes related to the manufacture of instruments, reagents and consumables for IVDs;
• Excellent communication skills and attention to details;
• Strong organizational skills and ability to multitask across projects and activities;
• Proven ability to collaborate cross-functionally and participate on multi-disciplinary teams.

• 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!

• Build the QC foundation that keeps our instruments, reagents and consumables reliable- from incoming materials through final product release.
• You’ll work directly with Manufacturing, Engineering, and Assay Development to define test methods, release criteria, and investigations that materially shape how we move…