Job Description
Nova Biomedical is hiring a QC Analyst Level II on our Analyzer Testing team in our Enterprise Rd, Billerica, MA facility.
As an individual contributor and a member of the QC Analyzer Test group, you will be responsible for the completion of the work assigned to you. In this role you will contribute to the overall success of the Quality Control (QC) Department. Under general supervision and following established procedures and guidelines, this position supplies assistance and support to the manufacturing operations (analyzer areas) and R&D groups. As a member of the Quality Control Analyzer Test Group in Billerica, you will be skilled in the execution of Final System Testing (FST) of instruments and/or analyzers. All testing is performed according to established procedures, working with Manufacturing and/or Quality Engineering to remedy failures. Employee will also be responsible for accurately documenting all completed work in the appropriate Device History Record (DHR) and is responsible for maintaining adequate levels of supplies. Employee will be assigned the maintenance of Quality Control test equipment. The employee will support the Quality Real Time Inspectors. The employee will train other Test Technicians and will be expected to travel back-and-forth to the Waltham facility when needed.
Other responsibilities include:
- Differentiating between system and product failures.
- Reading and understanding APs, TPs, OIs, OPs, MVs, ECOs, test data and any other documentation in the DHR for the area.
- Completing all work assigned in a complete and compliant manner documenting all testing or work in accordance with Nova and Quality Control policies and procedures.
- Testing with and/or handling biohazard material.
- Detecting and reporting of discrepancies to appropriate personnel.
- Performing misc. job tasks.
- Recording and reviewing test data accurately and in accordance with established test procedures.
- Maintaining adequate levels of supplies.
- Testing at labor standards.
- Working with engineering and manufacturing personnel regarding quality issues encountered.
- Testing Instruments and Analyzers for all Nova product lines.
- Performing troubleshooting independently for fluidic and mechanical failures.
- Performing normal preventive maintenance of tools, equipment and instruments.
- Assisting in evaluations, qualifications and pilot testing.
- Training Level I and Level II QC Test Technician.
- Communicating across shifts for daily work priorities.
- Preparing and placing document Engineering Change Order with Documentation Control.
- Traveling to Waltham to support final system test of new product lines, or other necessary testing, as needed and requested.
- Supporting QC Real Time Inspectors.
- Assisting in creating and revising testing procedures for new and existing product.
- Gaining complete system knowledge and a full understanding of instrument theory as it relates to assigned responsibilities.
Qualifications:
- Read, write, speak and understand English.
- Knowledge of basic to advanced skills in Word, Excel, and PowerPoint.
- Familiar with Good Documentation Practices (GDP) and Good Laboratory Practices (GLP).
- Knowledge of blood handling (Universal Precautions, storage conditions, etc).
- Ability to learn and teach
- Experience editing written protocols or procedures in the execution of daily assigned work and working in a Quality System Regulated (QSR) FDA regulated industry.
- Ability to pay attention to detail.
- Math skills and able to use a calculator.
Education/Experience:
- HS diploma, or equivalent, with a concentration in the sciences with 7+ years¿ experience as a QC tester working in a medical device, equivalent biotechnology or pharmaceutical environment.
- Associates Degree with a concentration in the sciences and 4 plus years' experience as a QC tester working in a medical device, equivalent biotechnology orpharmaceutical environment.
How To Apply
Please email your resume to thavrith.thao@masshirelowellcc.com for consideration
