Quality Control Inspector Review and Release
Nova Biomedical, Waltham, MA, United States
Overview
Nova Biomedical is the unified brand of Advanced Instruments and Nova Biomedical, delivering value to customers in the biopharmaceutical and clinical markets. With headquarters in Norwood and Waltham, Massachusetts, and a global team, Nova Biomedical focuses on osmolality testing and biotechnology and in vitro diagnostic (IVD) instrumentation, committed to advancing patient care and scientific discovery.
We are a mission-driven organization that values innovation, growth, and real-world impact on global health.
What You’ll Do
This role is responsible for the completion of the work assigned to you and will contribute to the overall success of the Quality Control (QC) Department.
Under limited supervision and following established procedures and guidelines, provide assistance and support to the manufacturing operations (consumables or Reagent department areas) and R&D groups.
Perform Real Time Inspection of the Reagent Department filling and packaging, review of Device History Records (DHR), inspection of labels/final products, execution of line clearances, and processing of Non-Conforming Materials in support of Manufacturing’s schedule.
Possess strong experience in the inspection of consumables and fluid manufacturing products.
Electronically transact product to Finished Goods and generate and maintain certification for all released products. Retrieve DHRs per established procedures. Train other Review & Release Inspectors.
What We Are Looking For In You
Understanding of QSR, GMP, GDP requirements as they relate to assigned responsibilities
Ability to read and understand APs, TPs, OIs, OPs, drawings, MVs, ECOs, test data and other documentation in the DHR for the area
Correctly scan and file DHRs and product-related information as needed
Perform data entry as needed
Final approval of test results and the DHR for product release to Finished Goods
Perform inspection of documentation revisions
Perform visual and/or mechanical inspections on all completed consumable and Reagent Department products
Assist in the processing of non-conforming materials
Generate and maintain certification for reagent products and all consumables for customer use
Perform Real Time Inspections in both the Reagent Department and consumables
Perform or verify area inspections
Communicate to QC group staff and supervisor information to maximize quality and productivity
Attend meetings when required
What We Are Looking For In You (Qualifications)
List Qualifications/Requirements for role
Physical Requirements for this role include:
Ability to pay attention to detail
Ability to multi-task
Math skills and ability to use a calculator
Basic to advanced computer knowledge and use
Able to follow written protocols in a Quality System Regulated (QSR) FDA regulated industry
The full list of physical requirements for this role is available upon request
Why work for Nova Biomedical
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 & Compensation
Work Location: on-site in our Waltham facility 5 days/week (M-F)
Targeted Salary Range: $22.00 - $29.00/hour
Working Hours: 3:00PM - 11:30PM
EEO Statement
Nova Biomedical takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As 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.
Privacy policy
https://advancedinstruments.showpad.com/share/DmsEd5QTLlqemTYABlvDW
#J-18808-Ljbffr
Nova Biomedical is the unified brand of Advanced Instruments and Nova Biomedical, delivering value to customers in the biopharmaceutical and clinical markets. With headquarters in Norwood and Waltham, Massachusetts, and a global team, Nova Biomedical focuses on osmolality testing and biotechnology and in vitro diagnostic (IVD) instrumentation, committed to advancing patient care and scientific discovery.
We are a mission-driven organization that values innovation, growth, and real-world impact on global health.
What You’ll Do
This role is responsible for the completion of the work assigned to you and will contribute to the overall success of the Quality Control (QC) Department.
Under limited supervision and following established procedures and guidelines, provide assistance and support to the manufacturing operations (consumables or Reagent department areas) and R&D groups.
Perform Real Time Inspection of the Reagent Department filling and packaging, review of Device History Records (DHR), inspection of labels/final products, execution of line clearances, and processing of Non-Conforming Materials in support of Manufacturing’s schedule.
Possess strong experience in the inspection of consumables and fluid manufacturing products.
Electronically transact product to Finished Goods and generate and maintain certification for all released products. Retrieve DHRs per established procedures. Train other Review & Release Inspectors.
What We Are Looking For In You
Understanding of QSR, GMP, GDP requirements as they relate to assigned responsibilities
Ability to read and understand APs, TPs, OIs, OPs, drawings, MVs, ECOs, test data and other documentation in the DHR for the area
Correctly scan and file DHRs and product-related information as needed
Perform data entry as needed
Final approval of test results and the DHR for product release to Finished Goods
Perform inspection of documentation revisions
Perform visual and/or mechanical inspections on all completed consumable and Reagent Department products
Assist in the processing of non-conforming materials
Generate and maintain certification for reagent products and all consumables for customer use
Perform Real Time Inspections in both the Reagent Department and consumables
Perform or verify area inspections
Communicate to QC group staff and supervisor information to maximize quality and productivity
Attend meetings when required
What We Are Looking For In You (Qualifications)
List Qualifications/Requirements for role
Physical Requirements for this role include:
Ability to pay attention to detail
Ability to multi-task
Math skills and ability to use a calculator
Basic to advanced computer knowledge and use
Able to follow written protocols in a Quality System Regulated (QSR) FDA regulated industry
The full list of physical requirements for this role is available upon request
Why work for Nova Biomedical
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 & Compensation
Work Location: on-site in our Waltham facility 5 days/week (M-F)
Targeted Salary Range: $22.00 - $29.00/hour
Working Hours: 3:00PM - 11:30PM
EEO Statement
Nova Biomedical takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As 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.
Privacy policy
https://advancedinstruments.showpad.com/share/DmsEd5QTLlqemTYABlvDW
#J-18808-Ljbffr