QC Inspector, Level II Review and Release - First Shift

NOVA Biomedical GmbH; Waltham (MA); On-site; USD 50,000 - 70,000; Full time

Job summary

A leading company is seeking a QC Inspector Level II for the Review and Release team in Waltham, MA. This role is critical for ensuring product quality and compliance with FDA regulations. Responsibilities include inspecting Device History Records, performing quality inspections, and supporting manufacturing schedules. Candidates should possess a high school diploma and have relevant experience in Quality Control.

Benefits

Blue Cross Blue Shield medical plan

Tuition reimbursement

Matching 401K

Company subsidized cafeteria

Innovative scholarship program for children of employees

Qualifications

• 1+ years application experience as QC Inspector.
• Familiar with FDA regulated industry.
• Ability to follow written protocols.

Responsibilities

• Perform inspection of Device History Records and final products.
• Detect and report discrepancies.
• Train interns and junior inspectors.

Skills

Attention to detail

Good Documentation Practices (GDP)

Math skills

Basic to advanced computer knowledge

Education

High school diploma or equivalent in sciences

Associate's degree with concentration in sciences

Tools

Word

Excel

Access

PowerPoint

Job description

Career Opportunities with Nova Biomedical Corporation

Nova Biomedical is an Equal Opportunity Employer in compliance with Affirmative Action in hiring and promoting women, minorities, veterans and individuals with disabilities.

QC Inspector, Level II Review and Release - First Shift

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
• 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 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 a ble 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.