QUALITY ASSURANCE MANAGER jobs in Framingham, MA

QUALITY ASSURANCE MANAGER is responsible for the implementation of policies and procedures to ensure adherence to production quality standards. Monitors and audits process, material, and product testing against established standards and conducts a continuous analysis of quality defects and deviations. Being a QUALITY ASSURANCE MANAGER identifies deficiencies or gaps in testing activities and develops solutions to ensure adequate and robust quality processes. Optimizes processes to comply with existing and new regulatory requirements. Additionally, QUALITY ASSURANCE MANAGER typically requires a bachelor's degree. Typically reports to a director. The QUALITY ASSURANCE 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 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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Manager, Quality Assurance Operations
  • ElevateBio
  • Waltham, MA FULL_TIME
  • ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power cell and gene therapy processes, programs, and companies to their full potential.

    The Role:

    ElevateBio is looking for a Cell Therapy Manager, QA Operations to join their growing Quality Group at our BaseCamp facility in Waltham, MA. In this role, the Manager will be primarily responsible for providing Quality oversight over execution of clinical cell and gene therapy manufacturing for cGMP compliance through on the production floor interactions, review and approval of batch related documents, and events. This individual will manage a team of QA professionals and engage with other members within operational departments as a Quality partner by providing real-time support to achieve on-time closure of quality records and disposition. A successful candidate in this position has thorough understanding of cGMP, solves problems by applying a combination of best practices and creative solutions, proactively identifies opportunities for new initiatives, and serves as a subject matter expert within Quality related functions.

    Here's What You'll Do:

    • Develop and coach team members for fostering a collaborative environment and enabling performance.
    • Ensure timely delivery of final product through performance of disposition activities.
    • Serve as Quality Point-of-Contact for a client program.
    • Provide on-the-floor QA oversight and support in the GMP cleanroom to ensure compliance to GMP regulations throughout the manufacturing areas.
    • Perform receipt and disposition of incoming patient apheresis material.
    • Perform issuance verification of production documents and labels, to meet production schedule.
    • Ensure products are manufactured in compliance with regulatory and GMP guidelines.
    • Ensure all product-related Deviations are initiated, investigated, and resolved.
    • Ensure that associated CAPAs are initiated and resolved.
    • Perform review of quality records including lab investigations, work orders, and change controls.
    • Ownership of quality records such as impact assessments, major deviations, CAPAs and change controls.
    • Identify compliance risks and escalate the issues to appropriate levels of management for timely resolution.

    Requirements:

    • BA/BS degree with 7 years of experience in a pharmaceutical, biotechnology or biologics operation.
    • Experience in Viral Vectors, Cellular and Gene Therapy Products is desired.
    • Working knowledge and ability to apply GMPs.
    • Strong teamwork and collaborative skills.
    • Experience with manufacturing investigations, deviations, and CAPA.
    • Experience with change control practices and strategies.
    • Strong knowledge with aseptic manufacturing processes is preferred.
    • Experience in electronic Enterprise Management systems, Quality Management Systems, Document Management Systems.


    Why Join ElevateBio?

    ElevateBio is accelerating access to the cutting-edge technologies and expertise that will change the future of medicine. Our ecosystem combines multiple R&D technology platforms – including Life Edit, a next-generation, full-spectrum gene-editing platform; a proprietary induced pluripotent stem cell (iPSC) platform, and an RNA, cell, protein, and vector engineering platform – with BaseCamp®, our end-to-end genetic medicine cGMP manufacturing and process development business, to power the discovery and development of advanced therapeutics.

    With these leading-edge platforms and capabilities, we are enabling a broad breadth of biopharmaceutical companies in the development of their novel cell and gene therapies while also building our own innovative pipeline of cellular, genetic, and regenerative medicines. Together, we aim to be the dominant engine inside the world's greatest scientific advancements harnessing human cells and genes to alter disease.

    Our Mission:
    To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.

    Our Vision:
    We seek to be the world's most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated.

    ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

  • 21 Days Ago

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Quality Assurance Manager
  • Adaptimmune
  • Cambridge, MA FULL_TIME
  • Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific ...
  • 22 Days Ago

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Manager, GCP Quality Assurance
  • WaVe Life Sciences
  • Lexington, MA FULL_TIME
  • Wave Life Sciences (Wave) is a clinical-stage RNA medicines company committed to delivering life-changing treatments for people battling devastating diseases. We aspire to develop medicines across mul...
  • 23 Days Ago

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Manager, GCP Quality Assurance
  • Wave Life Sciences
  • Lexington, MA FULL_TIME
  • Wave Life Sciences (Wave) is a clinical-stage RNA medicines company committed to delivering life-changing treatments for people battling devastating diseases. We aspire to develop medicines across mul...
  • 23 Days Ago

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Quality Control Assurance Manager
  • PKF O'Connor Davies
  • Boston, MA OTHER
  • Overview OFFICE LOCATION: Hybrid in any of our MA, NYC, NY, NJ or CT offices. The Candidate’s primary scope of responsibility includes the review of financial statements and inspection/Engagement Qual...
  • 24 Days Ago

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Quality Assurance, CMC (Manager)
  • Karuna Therapeutics
  • Boston, MA FULL_TIME
  • Boston, MA (Hybrid) Position: Quality Assurance CMC (Manager) Position Summary Karuna is seeking an experienced and motivated individual to join our Quality Assurance team as Manager, CMC Quality Assu...
  • 1 Day Ago

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0 QUALITY ASSURANCE MANAGER jobs found in Framingham, MA area

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Quality Assurance Manager
  • The Judge Group
  • Taunton, MA
  • A Food manufacturing company in the Southern Boston area is looking for a Quality Assurance Manager to join a well-estab...
  • 3/28/2024 12:00:00 AM

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Quality Assurance Manager
  • The Judge Group
  • Attleboro, MA
  • A Food manufacturing company in the Southern Boston area is looking for a Quality Assurance Manager to join a well-estab...
  • 3/28/2024 12:00:00 AM

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Quality Assurance Manager
  • The Judge Group
  • Providence, RI
  • A Food manufacturing company in the Southern Boston area is looking for a Quality Assurance Manager to join a well-estab...
  • 3/28/2024 12:00:00 AM

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QA Manager
  • The Judge Group
  • Boston, MA
  • Judge Direct Placement is seeking a Quality Assurance Manager for a large food/beverage manufacturing company located in...
  • 3/28/2024 12:00:00 AM

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Software Quality Assurance Manager
  • CY9
  • Acton, MA
  • Lead and manage the embedded Software Quality assurance team ensure Software verification is conducted in accordance to ...
  • 3/27/2024 12:00:00 AM

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Quality Assurance Manager - Pharma/Medical Devices
  • Collabera
  • Cambridge, MA
  • Job Description Job Description Title: Quality Assurance Manager Location: Cambridge, MA Duration: 12+ months Descriptio...
  • 3/27/2024 12:00:00 AM

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Quality Assurance Manager
  • Nasoya Foods USA, LLC.
  • Ayer, MA
  • Job Description Job Description Nasoya has introduced millions of Americans to our versatile plant protein and grown to ...
  • 3/26/2024 12:00:00 AM

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Functional Quality Assurance Manager / Chelmsford, MA
  • Lockheed Martin
  • Chelmsford, MA
  • Job ID: 661173BR Date posted: Feb. 15, 2024 Program: Functional Description:Lockheed Martin is seeking to hire a Functio...
  • 3/24/2024 12:00:00 AM

Framingham is located at 42°17′59″N 71°25′35″W / 42.29972°N 71.42639°W / 42.29972; -71.42639 (42.299795, −71.426627). According to the United States Census Bureau, the city has an area of 26.4 square miles (68.5 km²). 25.1 square miles (65.1 km²) of it is land and 1.3 square miles (3.4 km²) of it (4.99%) is water. Framingham is in eastern Massachusetts, 20 miles (32 km) west of Boston, midway between Boston and Worcester. It is bordered by Southborough and Marlborough on the west; Sherborn and Ashland on the south; Natick on the east; Wayland on the northeast; and Sudbury on the north. The ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for QUALITY ASSURANCE MANAGER jobs
$129,330 to $169,048
Framingham, Massachusetts area prices
were up 2.5% from a year ago

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Whatever type of industry you work in, be it retail, health care, software, manufacturing or another industry, chances are that a quality assurance manager helps your business meet and exceed quality-control standards for your services and products.
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