Nova Biomedical is hiring a QC Inspector Level II on our Review and Release team in our Waltham, MA facility. In this position the QC Inspector will be partnering with the Quality Control Supervisor assisting with the responsibility for the day to day operation of your assigned Quality Control group. This includes ensuring the quality of all products manufacturing by/received at Nova Biomedical in the Waltham facility. Hours: 7:00 AM - 3:30 PM.

As an individual contributor and a member of the QC Review and Release group you will be responsible for the completion of the work assigned to yourself. 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 (consumables or reagent department areas) and R&D groups.

As a member of the Review/Release Quality Control Group in Waltham, you will be responsible for performing the review of Device History Records (DHR), the inspection of labels/final products, the performance of line clearances, and possibly the processing of Non-Conforming Materials in support of Manufacturing's schedule. The employee will be skilled in the inspection of consumables and fluid manufacturing products. The employee will be trained to electronically transact product to Finished Goods. The employee will be responsible for internally retrieving various DHRs per the DHR Retrieval Protocol. The employee will train Intern, Level I, and Level II Review and Release inspectors.

Other Essential Responsibilities and Accountabilities include:

• Read and understand APs, TPs, OIs, OPs, drawings, MVs, ECOs, test data and any other documentation in the DHR for the area
• Completion of all work assigned in a complete and compliant manner documenting work in accordance with Nova and Quality Control policies and procedures
• Correctly scan and file DHRs and product related information
• Detection and reporting of discrepancies to appropriate personnel
• Perform data entry
• Final approval of test results and the DHR for product to be release to Finished Goods
• Perform electronic transactions for completed Reagent product and consumables, as required
• Perform inspection of documentation revision
• Perform label and pallet inspections for Reagent Department products
• Perform label inspections
• Perform misc. job tasks
• Perform visual and/or mechanical inspections on all completed consumables and Reagent Department products
• Inspect and review at labor standards
• Work with engineering and manufacturing personnel regarding quality issues encountered
• DHR Retrieval Process
• Will generate and maintain certification for reagents and all consumables for customer use
• Will train Interns, Level I, and Level II QC inspectors
• Will communicate across shifts for daily work priorities

Qualifications:

• Read, write, speak, and understand English
• Familiar with Good Documentation Practices (GDP)
• Computer literate in Word, Excel, Access, and Powerpoint
• Ability to pay attention to detail
• Math skills and able to use a calculator
• Basic to advances computer knowledge and use
• Ability to follow written protocols or procedures in the execution of daily assigned work and working in a Quality System Regulated (QSR) FDA regulated industry

Education/Experience:

• High school diploma, or equivalent with a concentration in the sciences plus 1 plus years of application experience as a QC Inspector
• Associate's degree with a concentration in the sciences

At Nova Biomedical, we practice our core values of mutual respect, honesty, and integrity throughout the company. With a strong sense of family in the workplace, we are proud that one third of all our employees have been with us for over 10 years.

Highlights of benefits offered to Nova Biomedical employees include Blue Cross Blue Shield medical plan, tuition reimbursement, matching 401K, company subsidized cafeteria and an innovative scholarship program for children of employees.