Quality Assurance Engineering Manager jobs in New Brunswick, NJ

Quality Assurance Engineering Manager manages inspections of raw materials, equipment, processes, and finished products. Implements quality standards and protocols for quality assurance testing models. Being a Quality Assurance Engineering Manager assists in the design and implementation of policies and procedures for testing and evaluating the precision and accuracy of products and/or equipment. Ensures projects are completed on time and within budget. Additionally, Quality Assurance Engineering Manager acts as a technical advisor to quality assurance engineering team regarding projects, tasks, and operations. Requires a bachelor's degree. Typically reports to a head of a unit/department. The Quality Assurance Engineering Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Quality Assurance Engineering Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)

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Senior Manager, Quality Assurance
  • Rocket Pharmaceuticals
  • Cranbury, NJ FULL_TIME
  • Overview

    Work at ROCKET PHARMA and help cure rare diseases!

     

    Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.

    Position Summary

    We are seeking a Senior Manager, Quality Assurance responsible for in-house and outsourced activities supporting Rocket’s Cranbury, NJ GMP viral vector drug substance manufacturing and testing facility.  The incumbent will ensure conformance to Rocket’s quality standards and regulatory requirements while developing and continually improving quality systems and related processes such as validation, material control and disposition, risk management and training.   

    Responsibilities

    • Provide support for the transition from phase-appropriate to commercial expectations for site-related GMP activities
    • Perform equipment, utility, and facility qualification/validation protocol review and approval including both pre and post execution. Support closure of exceptions and approval of final reports.
    • Perform product release activities, including reviews of batch records, and other documentation for product release/disposition.
    • Assess and approve analytical related documents, including validation protocols/reports, stability, shelf-life extension, drug substance and drug product testing data and OOS
    • Assess change controls for risks and impact on processes, product, and programs
    • Pro-actively identify and escalate business-critical issues affecting Compliance, Operations, and Quality Assurance
    • Review raw data and data summaries presented in internal reports and regulatory submissions
    • Work with subject matter experts to define and implement process and procedure improvements
    • Review and approve SOP’s, specifications, and other controlled documents
    • Provide support with tracking and trending deviations, corrective actions, and process data
    • Provide support to ensure audit observations, changes, and corrective actions are addressed and closed in a timely manner
    • Provide support for reviews of product and program risk, working with subject matter experts and key stakeholders to ensure communication and timely follow-up of mitigation activities
    • Provide support with coordination and execute quality assurance activities during technology transfer projects

    Qualifications

    • BS degree (minimum) in biological sciences or related field of study.  Advance degree is a plus
    • 8 years of relevant experience in biological sciences or biotechnology within quality assurance, quality control, biomanufacturing, clinical and/or regulatory operations.
    • 6 years of experience with Masters degree in biological sciences or biotechnology
    • Preference given to candidates with 3 years of cell and gene therapy experience, in manufacturing, Quality Control or Quality Assurance
    • Hands-on experience in the interpretation and application of cell and gene therapy regulations and guidance documents
    • Thorough knowledge of cGMPs (CFR/ICH/EU) and applicable international regulations and guidelines as they apply to drug manufacturing and aseptic processing
    • Demonstrated ability to interpret and apply pharmaceutical industry regulatory compliance requirements with an emphasis on US and EU GMP/GLP/GCP regulations.
    • Demonstrated ability to think and communicate clearly.
    • Ability to work as part of a cross-functional team in a dynamic, fast-paced environment

    EEO Statement

    A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.

  • 23 Days Ago

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Janitorial Quality Assurance Manager
  • ServiceMaster Cleaning and Restoration Services bu Elnajjar
  • North, NJ FULL_TIME
  • Our essential team members enjoy: Competitive Pay*Flexible Schedules Career Path Opportunities Paid Training For more than 60 years, ServiceMaster Clean has been creating cleaner, healthier, safer wor...
  • 9 Days Ago

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Manager, Quality Assurance- Clinical
  • Rocket Pharmaceuticals
  • Cranbury, NJ FULL_TIME
  • Overview Work at ROCKET PHARMA and help cure rare diseases! Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood dis...
  • 1 Month Ago

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Quality Assurance Manager
  • Renaissance Lakewood LLC
  • Lakewood, NJ FULL_TIME
  • Overview Quality Assurance Manager sought by Renaissance Lakewood LLC in Lakewood, New Jersey. Responsible for the overall performance of Quality Assurance inspection group dealing with deviations, ch...
  • 1 Month Ago

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Quality Assurance Operations - Quality Manager Quality Manager
  • Eclaro
  • Brunswick, NJ FULL_TIME
  • Quality ManagerJob Number: 24-00838 Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Quality Manager for our client in New Brunswick, NJ. Eclaro’s client ...
  • 16 Days Ago

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DDD Quality Assurance Manager/ Trainer
  • Prestige Home Care
  • Lakewood, NJ FULL_TIME
  • $50-$70 Job Summary: The Trainer Specialist is a professional in the field of DDD who will provide a system of continuing quality improvement as well as training for the agency’s programs and its staf...
  • 2 Months Ago

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0 Quality Assurance Engineering Manager jobs found in New Brunswick, NJ area

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Manufacturing Quality Manager
  • Dexian - DISYS
  • New Brunswick, NJ
  • Title- Manufacturing Quality Manager Duration- 12+ months Location- New Brunswick, NJ Pay range- $44 to $46/hr Job Funct...
  • 3/28/2024 12:00:00 AM

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Quality Control Warehouse Technician
  • Tenna
  • Edison, NJ
  • * BY ROLE + + + **Quality Control Warehouse Technician** **Full-time** **Edison, New Jersey** **About** Tenna is searchi...
  • 3/28/2024 12:00:00 AM

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Product/Process Quality Engineer
  • Demant
  • Somerset, NJ
  • Overview: When you become part of the Demant family, you also become part of our quest to make a life-changing differenc...
  • 3/27/2024 12:00:00 AM

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Manufacturing Quality Manager
  • Dexian
  • New Brunswick, NJ
  • Title- Manufacturing Quality Manager Duration- 12+ months Location- New Brunswick, NJ Pay range- $44 to $46/hr Job Funct...
  • 3/25/2024 12:00:00 AM

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Senior Supplier Quality Engineer
  • Diverse Lynx
  • Edison, NJ
  • Job Title: Senior Supplier Quality Engineer Location: Irvine, CA (Day 1 onsite) Duration: Fulltime Job Description: Work...
  • 3/25/2024 12:00:00 AM

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Director of Quality
  • R&D Interconnect Solutions
  • South Plainfield, NJ
  • Job Description Job Description Job Description Quality Director will be responsible for maintaining end-to-end Supply C...
  • 3/25/2024 12:00:00 AM

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Manufacturing Engineer
  • Gemco
  • Middlesex, NJ
  • Job Description Job Description The Manufacturing Engineer is responsible for eliminating waste in the manufacturing pro...
  • 3/25/2024 12:00:00 AM

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Manager Manufacturing Engineering and Maintenance
  • Kaztronix LLC
  • New Brunswick, NJ
  • Sr Manager Manufacturing Engineering and Maintenance Pharmaceutical Company Oral Solid Dosage experience The Director is...
  • 3/24/2024 12:00:00 AM

According to the United States Census Bureau, the city had a total area of 5.789 square miles (14.995 km2), including 5.227 square miles (13.539 km2) of land and 0.562 square miles (1.456 km2) of water (9.71%). New Brunswick is in Raritan Valley (a line of cities in central New Jersey). New Brunswick is on the south side of Raritan Valley along with Piscataway Township, Highland Park, Edison Township, and Franklin Township (Somerset County). New Brunswick lies southwest of Newark and New York City and northeast of Trenton and Philadelphia. New Brunswick is bordered by Piscataway, Highland Park...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Quality Assurance Engineering Manager jobs
$142,126 to $176,618
New Brunswick, New Jersey area prices
were up 1.5% from a year ago

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