Quality Assurance Specialist jobs in Massachusetts

Quality Assurance Specialist implements company and regulatory quality standards for product manufacturing. Knowledgeable of industry and governmental quality regulations. Being a Quality Assurance Specialist audits and reviews quality data according to existing procedures. Documents results in required format. Additionally, Quality Assurance Specialist requires a bachelor's degree or equivalent. Typically reports to a manager or head of a unit/department. The Quality Assurance Specialist work is closely managed. Works on projects/matters of limited complexity in a support role. To be a Quality Assurance Specialist typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)

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Quality - Quality Assurance Specialist
  • TechDigital Corporation
  • Devens, MA FULL_TIME
  • 1. PURPOSE AND SCOPE OF POSITION:

    The Quality Assurance Product Disposition Specialist is responsible for supporting quality and disposition activities at the Devens, MA Cell Therapy manufacturing facility, in accordance with Client policies, standards, procedures and Global cGMP. The role will aid in the routine and timely release of drug product in the Cell Therapy Facility and assure the quality of manufactured products is in compliance with all applicable regulations and guidelines.

    Functional responsibilities include preparing deliverables for product release within the inventory management system (SAP).

    2. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

    • Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, related discipline, or its equivalent.

    • Previous work/academic experience where attention to detail and personal accountability were critical to success.

    • Strong communication skills and the ability to follow written and verbal instructions.

    • Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected.

    • Knowledge of electronic systems including any of the following preferred: SAP, Veeva, LIMS/Celabs, Infinity, and electronic batch recording.

    3. DUTIES AND RESPONSIBILITIES

    • Prepares documentation and deliverables per Standard Operating Procedures required for drug product disposition.

    • Works in electronic systems such as SAP, Learning Management, and Document Management systems.

    • Verify accuracy and acceptability of drug product documentation, such as Certificate of Analysis or deviation reports, to support drug product lot disposition.

    • Perform the review of batch genealogy for all raw materials and components used in each batch to ensure that they are approved and released.

    • Works in electronic systems such as SAP, Learning Management, and Document Management systems.

    • Works on assignments of simple to moderate complexity where some judgment is required in resolving problems and making routine recommendations.

    • May contribute to drafting, reviewing, or approving procedural documents.

    • Other duties as required.

    4. EDUCATION AND EXPERIENCE

    • B.S., in science, engineering, biochemistry, related discipline, or its equivalent

    • 0-2 years of directly relevant experience in a regulated cGMP environment.

    • Any combination of education, experience, and military service in line with recommendations above will be considered.

    5. WORKING CONDITIONS:

    • Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

    This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

    This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
  • 27 Days Ago

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Quality assurance specialist
  • Proclinical Staffing
  • Cambridge, MA FULL_TIME
  • Proclinical is seeking a Quality Assurance Specialist - Batch Disposition for a global pharmaceutical company located in Cambridge, MA. In this role, you will be responsible for overseeing the quality...
  • Just Posted

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Quality Assurance Specialist
  • Dianne's Fine Desserts
  • Newburyport, MA FULL_TIME
  • Why should you join our team? At Dianne's Fine Desserts you'd be part of the rapidly growing Dessert Holdings Family, offering potential career growth opportunities. Dessert Holdings is North America’...
  • Just Posted

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Quality Assurance Specialist
  • US Defense Contract Management Agency
  • Pittsfield, MA FULL_TIME
  • Duties Performs duties associated with the administration of the quality assurance provisions of contracts by designing, implementing, and maintaining a risk-based surveillance program and assessment ...
  • Just Posted

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Supervisory Quality Assurance Specialist
  • US Defense Contract Management Agency
  • Chicopee, MA FULL_TIME
  • Duties Plans, directs, and implements in-plant quality assurance programs for contracts assigned to the Contract Management Office (CMO). Guides, motivates, and oversees subordinates with a focus on p...
  • 1 Day Ago

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Senior Specialist Quality Assurance
  • 3205 St. Jude Medical, Cardiology Division, I
  • Burlington, MA FULL_TIME
  • Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and ...
  • 1 Day Ago

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Quality Assurance Specialist
  • Manpower
  • Cockeysville, MD
  • Quality Assurance Specialist Pay rate: $21 Our client in Baltimore, Maryland is looking for hardworking, motivated talen...
  • 5/9/2024 12:00:00 AM

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Quality Assurance Specialist
  • Dairy Farmers of America
  • El Dorado Springs, MO
  • GENERAL PURPOSE Participate in the evaluation and measurement of compliance against quality assurance and food safety pr...
  • 5/9/2024 12:00:00 AM

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Quality Assurance Specialist (3474)
  • Three Saints Bay, LLC
  • Norfolk, VA
  • Ghostrock, LLC a subsidiary of Three Saints Bay, LLC, and a federal government contractor is seeking a Quality Assurance...
  • 5/8/2024 12:00:00 AM

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Quality Assurance Specialist
  • Defense Logistics Agency
  • Philadelphia, PA
  • Summary See below for important information regarding this job. Selected applicants will serve as entry-level trainees i...
  • 5/8/2024 12:00:00 AM

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Senior Quality Assurance Specialist
  • Atlas Copco
  • Haverhill, MA
  • The main focus for this position is to deploy and integrate a world class Quality Management System that is aligned acro...
  • 5/6/2024 12:00:00 AM

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Quality Assurance Specialist
  • ClinLab Staffing
  • Lowell, MA
  • QA Specialist Location: Lowell, MA Summary of Primary Responsibilities: The Quality Assurance (QA) Compliance Specialist...
  • 5/6/2024 12:00:00 AM

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Quality Assurance Specialist
  • Orion Engineering Services
  • Worcester, MA
  • Job description Quality Assurance Specialist $27 - $30 per hour with option for medical benefits. 6 month initial contra...
  • 5/6/2024 12:00:00 AM

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Quality Assurance Specialist / QP
  • Haleon
  • București, Municipiul București
  • Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving e...
  • 4/9/2024 12:00:00 AM

Massachusetts is the 7th-smallest state in the United States. It is located in the New England region of the northeastern United States and has an area of 10,555 square miles (27,340 km2), 25.7% of which is water. Several large bays distinctly shape its coast. Boston is the largest city, at the inmost point of Massachusetts Bay, and the mouth of the Charles River. Despite its small size, Massachusetts features numerous topographically distinctive regions. The large coastal plain of the Atlantic Ocean in the eastern section of the state contains Greater Boston, along with most of the state's po...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Quality Assurance Specialist jobs
$67,073 to $84,918

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