Specialist, CAPA II

3 weeks ago


Worcester Massachusetts, United States AbbVie Full time
Job Description

Join our team as a Quality Investigator and play a critical role in ensuring that our products meet the highest standards of quality and safety. As a Quality Investigator, you will be responsible for independently leading complex investigations and ensuring that all investigations are written according to corporate and site requirements. You will also have the opportunity to promote a culture of continuous improvement by identifying problems, conducting root cause analysis, and implementing corrective and preventive actions.

If you are passionate about quality and want to make a meaningful impact in a dynamic and collaborative environment, we encourage you to apply.

Responsibilities

Provides consistent and thorough exception documents and timely resolution of investigations based on CAPA requirements

Coordinates the exception document process and creates exception documents

Independently leads complex, high impact investigations

Ensures all investigations are written according to corporate and site requirements

Ensures all applicable regulatory requirements are met for the implementation and maintenance of the Quality System

Ensures all Quality CAPA goals and metrics are met

Promotes culture of continuous improvement by identifying problems, conducting root cause analysis and confirming appropriate implementation of corrections, corrective and preventive actions

Maintains an effective liaison and cooperative relationship with other Quality areas and departments within the plant


  • Specialist, CAPA II

    2 weeks ago


    Worcester, United States AbbVie, Inc Full time

    Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services...


  • Worcester, Massachusetts, United States University of Massachusetts Medical School Full time

    Overview: POSITION SUMMARY: Under the general direction of the Department Administrator, or designee, the Grant and Contract Specialist I is responsible for performing diversified and complex administrative, financial, and pre and post-award budgetary functions in support of departmental activities, to include both responsibilities for both restricted and...


  • Worcester, United States AbbVie Full time

    **Company Description** The Sr Specialist Quality Systems is responsible for providing quality assurance support for some or all of the following manufacturing processes: pharmaceutical products, medical devices, combination products and biologics. Specific areas of support may include the Document Center, Device QA, Labeling, Validation, Training and CAPA....

  • Process Engineer

    4 days ago


    Worcester, United States Azzur Group Full time

    DescriptionJob Summary: As a Process Engineer specializing in Single-Use (SU) equipment, you will play a crucial role in designing, optimizing, and troubleshooting processes utilizing SU technologies, with a particular focus on Tangential Flow Filtration (TFF), Chromatography (Chrome), SU mixers, and Liquid Nitrogen (LNP) equipment. You will be responsible...

  • Process Engineer

    3 days ago


    Worcester, United States Azzur Group Full time

    Description Job Summary: As a Process Engineer specializing in Single-Use (SU) equipment, you will play a crucial role in designing, optimizing, and troubleshooting processes utilizing SU technologies, with a particular focus on Tangential Flow Filtration (TFF), Chromatography (Chrome), SU mixers, and Liquid Nitrogen (LNP) equipment. You will be responsible...


  • Worcester, United States The Fountain Group Full time

    Hello, The Fountain Group is a national staffing firm and are currently seeking a Warehouse Specialist for a prominent client of ours. This position is in Worcester, MADetails for the position are as follows: Job Description: 6 month contract Pay - $26.40 Shift - Monday to Friday (2-10:30pm) Assists for all general Receiving and Shipping operations in GMP...

  • QA Specialist I

    21 hours ago


    Agawam, Massachusetts, United States Cambrex Full time

    Overview: The QA Specialist I supports the Quality Management System (QMS) and the Document Management System (DMS) in a GMP regulated environment according to established operating procedures. The QMS and DMS functional areas include but are not limited to: Document Control, Training, Deviations, Out of Specification Investigations, Corrective and...


  • Worcester, United States AbbVie, Inc Full time

    Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services...

  • Research Associate

    2 weeks ago


    Worcester, United States University of Massachusetts Medical School Full time

    Overview POSITION SUMMARY: Under the direction of the Principal Investigator (PI) or designee, the Stem Cell Differentiation Research Associate IV provides operational support to the laboratory. Join the UMass Chan Diabetes Center of Excellence (part of the Juvenile Diabetes Research Foundation's New England Center of Excellence) to engage in cutting edge...


  • Worcester, United States University of Massachusetts Medical School Full time

    Overview POSITION SUMMARY: Under the general direction of the Department Administrator, or designee, the Grant and Contract Specialist I is responsible for performing diversified and complex administrative, financial, and pre and post-award budgetary functions in support of departmental activities, to include both responsibilities for both restricted and...


  • Randolph, Massachusetts, United States Hebrew SeniorLife, Inc. Full time

    Overview: Hebrew SeniorLife employees set the highest standard in our commitment to redefine the experience of aging. With compassion, resilience, and determination, we make a difference in the lives of patients, residents, their families, and the broad senior care community every day. And they in ours as well. These life-changing connections give our work...


  • Worcester, United States University of Massachusetts Medical School Full time

    Overview: POSITION SUMMARY: Under the general direction of the Department Administrator, or designee, the Grant and Contract Specialist I is responsible for performing diversified and complex administrative, financial, and pre and post-award budgetary functions in support of departmental activities, to include both responsibilities for both restricted and...


  • Boston, Massachusetts, United States Vertex Pharmaceuticals Full time

    Job Description: JOB DESCRIPTION:  Sound understanding of GMP principles and their application to product quality and compliance, supporting commercial paper-based Executed Batch Record (EBR) and disposition of Drug Substance (DS)/ Active Pharmaceutical Ingredient (API), Spray Dried Dispersion (SDD), and/ or Drug Product (DP). The ideal candidate will have...


  • Worcester, Massachusetts, United States State of Maryland - MDH Local Health - Worcester County Full time

    Introduction\r GRADE17\r LOCATION OF POSITIONMDH Worcester County Health Department\r6040 Public Landing Road\rSnow Hill, MD 21863\r Main Purpose of JobThe main purpose of this full-time position will be to perform information technology support functions assigned to Office of Enterprise Technology (OET) staff of the Worcester Co HD. This position will also...


  • Worcester, United States University of Massachusetts Medical School Full time

    POSITION SUMMARY:Under the general direction of the Department Administrator, or designee, the Grant and Contract Specialist I is responsible for performing diversified and complex administrative, financial, and pre and post-award budgetary functions in support of departmental activities, to include both responsibilities for both restricted and unrestricted...


  • Worcester, United States AbbVie, Inc Full time

    Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services...


  • Tewksbury, Massachusetts, United States Cambridge Isotope Laboratories, Inc. Full time

    Cambridge Isotope Laboratories (CIL) has an outstanding opportunity for a Quality Assurance Specialist I to join the team responsible for the quality of several new and existing active pharmaceutical ingredients (APIs) and medical device components based onsite in our Tewksbury, MA location. CIL is the global leading company in a highly technical,...


  • Cambridge, Massachusetts, United States Editas Medicine Full time

    At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...


  • Cambridge, Massachusetts, United States Vertex Pharmaceuticals Full time

    Job Description: General Summary:   The Sr. Quality Operations Specialist will provide QA support of manufacturing operations, analytical laboratory operations and materials management for the external manufacturing programs at VCGT. This role will review batch data, including batch records, deviations, in-process data, EM data, QC release testing and...


  • Cambridge, Massachusetts, United States Editas Medicine Full time

    At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...