Quality Control Inspector Review and Release
novabio
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Benefits offered by this job
Job summary
Nova Biomedical is seeking a QC Inspector Sr Review & Release in Waltham, MA for 2nd shift (3:00PM–11:30PM) with differential. You will inspect reagents, review device history, approve test results for Finished Goods, and train other inspectors.
Strong attention to GMP/GDP and data trending is required. Responsibilities include real-time inspection, documentation, and collaboration with engineering and manufacturing to ensure quality and compliance in a FDA-regulated environment.
Qualifications
- High school diploma or equivalent with a science concentration and 5+ years of experience.
- 5+ years as a QC Inspector preferred with a science focus.
- Associate or higher may be considered with relevant experience.
Responsibilities
- Apply QSR, GMP, GDP requirements to responsibilities.
- Review Device History Records and perform inspections.
- Scan and file records; report discrepancies.
- Provide final approval of test results for product release.
- Train other Review & Release Inspectors; communicate priorities.
- Perform pallet and label inspections; assist with non-conforming materials.
- Generate certifications for reagent products and consumables.
Skills
Education
Tools
Job description
Nova Biomedical: One Global Brand. One Vision. Together under one name.
Advanced Instruments and Nova Biomedical are now united under one brand, Nova Biomedical, marking a major milestone in our journey to deliver greater value to our customers. By combining our strengths, we're accelerating innovation, supporting critical workflows, and delivering world-class service across the biopharmaceutical and clinical markets.
Nova Biomedical is seeking a QC Inspector Sr Review & Release Waltham to support Quality Control operations at the Waltham, MA facility. This role is responsible for ensuring the quality of products manufactured by and received at Nova Biomedical, with a focus on supporting consumables and Reagent Department manufacturing areas. The QC Inspector Sr Review & Release will perform real-time inspection of reagent filling and packaging, review Device History Records, inspect labels and final products, perform line clearances, support non-conforming material processing, electronically transact product to Finished Goods, and generate and maintain certification for released products. This position will also train other Review & Release Inspectors and contribute to the overall success of the Quality Control Department.
- Understand and apply QSR, GMP, and GDP requirements as they relate to assigned responsibilities.
- Read and understand APs, TPs, OIs, OPs, drawings, MVs, ECOs, test data, and other documentation within Device History Records.
- Complete all assigned work in a complete and compliant manner, documenting work in accordance with Nova Biomedical and Quality Control policies and procedures.
- Correctly scan and file Device History Records and product-related information as needed.
- Detect and report discrepancies to appropriate personnel.
- Perform data entry as needed.
- Provide final approval of test results and Device History Records for product release to Finished Goods.
- Perform and troubleshoot electronic transactions for completed product.
- Perform inspection of documentation revisions.
- Perform pallet inspections for Reagent Department products.
- Perform label inspections and report label discrepancies to the product engineer.
- Perform visual and/or mechanical inspections on completed consumable and Reagent Department products.
- Assist in the processing of non-conforming materials.
- Inspect and review above labor standards.
- Work with engineering and manufacturing personnel regarding quality issues encountered.
- Retrieve Device History Records according to established procedures.
- Generate and maintain certifications for reagent products and consumables for customer use.
- Train other Review and Release Inspectors.
- Communicate across shifts regarding daily work priorities.
- Perform real-time inspections in both the Reagent Department and consumables areas.
- Prepare Engineering Change Orders as an originator, as needed.
- Perform or verify area inspections.
- Communicate information to QC staff and supervisors to maximize quality and productivity.
- Attend meetings as required.
- High school diploma or equivalent with a concentration in the sciences and 5+ years of applicable experience required.
- 5+ years of experience as a QC Inspector preferred with a high school diploma or equivalent and science concentration.
- Associate degree with a concentration in the sciences and 3+ years of experience as a QC Inspector may be considered.
- Undergraduate degree with a concentration in the sciences and 1+ year of experience as a QC Inspector may be considered.
- Ability to read, write, speak, and understand English.
- Familiarity with Good Documentation Practices.
- Computer literacy in Microsoft Word, Excel, Access, and PowerPoint.
- Understanding of data trending techniques.
- Strong attention to detail.
- Ability to multi-task in a quality-controlled environment.
- Math skills and ability to use a calculator.
- Basic to advanced computer knowledge and use.
- Ability to follow written protocols and procedures while working in a Quality System Regulated and FDA-regulated industry.
- Ability to work cooperatively within the Quality Control Review & Release group, the broader QC Department, and cross-functional teams.
- Comfort with working at a computer for extended periods.
- Occasional need to move about the office to access meetings or resources.
- Able to communicate effectively via phone, video, and written communication.
- Capacity to lift and carry up to [25-50] pounds as required
- Flexible Medical, Dental, & Vision Coverage
- Competitive 401k company match
- Bonus Program, Generous PTO and paid holidays
- Generous Tuition reimbursement
- Professional development, engagement and events
- Company marketplace for lunch and snacks in our Norwood, MA and Billerica, MA offices
- Company subsidized cafeteria in our Waltham, MA office
Work Location: Onsite in our Waltham facility 5 days/week (M-F)
Nova Biomedical believes in transparency and integrity throughout all we do, including compensation. The provided salary range for this role represents the expected base salary or hourly rate for this opening. Actual compensation will be commensurate with the candidate’s experience and may vary based on individual factors such as location, skills, and education.
At Nova Biomedical, we’re not just building instruments, we’re powering breakthroughs that improve lives. Our smart, science-driven solutions are trusted in over 100 countries to speed drug development and enhance patient care.
Our integration brings together more than 70 years of scientific excellence with Nova’s cutting-edge innovation, forming a powerhouse of precision, purpose, and possibility. With FDA-registered, ISO-certified manufacturing, more than 125 FDA approvals, and industry-trusted diagnostics, we’re setting new standards in quality and reliability. Nova Biomedical is proud to be a global leader in osmolality testing and biotechnology and in vitro diagnostic (IVD) instrumentation, dedicated to advancing patient care and scientific discovery with a legacy that continues to shape the future of life sciences.
With headquarters in Norwood and Waltham, Massachusetts, and a global team of nearly 2,000 employees, we’re building a collaborative, empowered culture grounded in shared values: Customer Centricity, Ingenuity, Ownership & Accountability, Collaboration, and Integrity.
Working at Nova Biomedical means joining a mission-driven organization where your contributions matter. Whether you're in engineering, science, manufacturing, or support, you’ll be part of a team that values innovation, invests in your growth, and is committed to making a real-world impact on global health.
Explore what’s next with us at novabiomedical.com
Nova Biomedical takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Nova Biomedical will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
https://advancedinstruments.showpad.com/share/DmsEd5QTLlqemTYABlvDW
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