Our client develops, manufactures, and supplies a wide array of medical diagnostics products, services, tests, platforms, and technologies.

Role Overview :

The Quality Control Associate - Sequencing Cartridge Operations will be an integral part of a team that performs cartridge assembly and systems testing.

This individual will be responsible for the setup, execution, monitoring and data analysis of all Quality Control release activities associated with our client's Sequencing Process.

Duties :

• The individual will be responsible for review, generation and sign-off of quality documentation. The ideal candidate will be responsible for interfacing with highly complex systems and controls in an ISO 13485 and cGMP manufacturing environment.
• The individual will maintain areas in high state of inspection preparedness by maintaining equipment, records and laboratory environment in order to comply with regulatory requirements utilizing current regulations and Operating Procedures (OP).
• Additionally, maintains production documents and investigates laboratory exception events and works independently with general guidance from senior team members.
• Performs setup, execution and monitoring of Sequencing process for the Quality Control release of cartridge assemblies.
• Prepares sequencing platform equipment, test equipment and materials as required per procedure.
• Conduct data analysis of test results and determine Quality acceptability per approved procedures.
• Responsible for generating compliant QC documentation as part of the Device History Record, observations, test results and reports required for releasing items into inventory from the raw material to the in-process finished goods and final products.
• Perform a variety of QC duties relating to production manufacturing, including incoming and in-process QC inspections.
• Maintain records and QC lab environment to comply with cGMP, OP and regulatory requirements.
• Support 6S effort and continuous improvement to streamline overall operations and improve efficiency. Assist in performing maintenance of laboratory equipment.
• Assist in regular laboratory and manufacturing environmental monitoring testing.
• Assist in reagent and lab supply ordering and inventory management in order to support the QC laboratory.
• Ensures equipment is in compliance with calibration standards.
• May assist with troubleshooting and investigation of QC failures by working with others.
• May assist in transferring processes from development to QC.
• May assist in testing raw materials for reliability and stability.
• May assist in process monitoring and trending.
• May assist in collecting, interpreting and communicating process metrics for recommended improvements.
• May assist in performing, reviewing and / or generating validations for QC processes and laboratory equipment.

Qualifications :

• HS Diploma Minimum with 4 years of experience
• Associate's Degree with 3 years of experience
• Bachelor's Degree with 1 or more years of experience

Knowledge, Skills and Abilities :

• other functions and management regarding resolving testing, investigations and theory
• Strong data-analysis skills, with clear demonstrated understanding of analytical,
• troubleshooting and problem solving skills.
• Hands on experience in a laboratory
• Accurate and precise manual pipetting and measuring techniques
• Demonstrated attention to detail and strong organizational skills
• Ability to utilize electronic office suite of computer programs
• Proven ability to meet deadlines and work under aggressive timelines
• Demonstrated ability to work effectively in a team environment
• Experience working in GLP, cGMP or ISO regulated environment
• Experience with 6S and Lean techniques
• Experience with handling corrosive and biohazardous reagents
• Work is performed in a laboratory environment
• Schedule could include overtime and shift work in the future as business needs require .
• May work with hazardous materials and chemicals

Last updated : 2024-05-31