Quality Assurance Specialist jobs in Boston, MA

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.
  • 12 Days Ago

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Quality Assurance Specialist I
  • Vericel
  • Cambridge, MA FULL_TIME
  • Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Quality Assurance professional looking to joi...
  • 21 Days Ago

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EHR Quality Assurance Specialist
  • Northeast Family Services Career Center
  • Dorchester, MA FULL_TIME
  • Northeast Family Services is looking for an experienced EHR Quality Assurance Specialist to join our growing team. Don’t miss this opportunity to take your career to the next level and join a growing,...
  • Just Posted

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Quality Assurance Specialist
  • Fortuna BMC
  • Lynnfield, MA FULL_TIME
  • In this role as a Mailroom Quality Assurance Associate, you will play a vital part in ensuring the quality and compliance of our print-mail services. You'll be a key figure in maintaining our high sta...
  • Just Posted

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Quality Assurance Specialist (Mechanical)
  • Defense Contract Management Agency
  • Lynn, MA FULL_TIME
  • See below for important information regarding this job. Additional vacancies may be filled from this announcement.
  • 14 Days Ago

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Quality Assurance Specialist III
  • LanceSoft Inc
  • Lexington, MA FULL_TIME
  • Job DescriptionDescriptionThe Quality Assurance Professional will work in the US External QA team responsible for Contract Manufacturing (CMO) and Contract Test Laboratories (CTL) oversight within the...
  • 1 Month Ago

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0 Quality Assurance Specialist jobs found in Boston, MA area

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Training and Quality Assurance Specialist
  • Complete Staffing Solutions, Inc.
  • Methuen, MA
  • Job Description Job Description Reports To: Customer Support Leadership Schedule: M-F 8.30-5pm Position Summary: Under t...
  • 4/24/2024 12:00:00 AM

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Quality Assurance Specialist
  • Katalyst HealthCares and Life Sciences
  • Boston, MA
  • Responsibilities: Quality Assurance: Assist in the implementation and maintenance of quality assurance programs for cell...
  • 4/22/2024 12:00:00 AM

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Senior Quality Assurance Specialist
  • QIAGEN
  • Beverly, MA
  • Overview At the heart of QIAGEN's business is a vision to make improvements in life possible. We are on an exciting miss...
  • 4/22/2024 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...
  • 4/21/2024 12:00:00 AM

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Quality Assurance Specialist
  • US Tech Solutions
  • Worcester, MA
  • Job Description: The Quality Associate supports the Quality Function that they are responsible for within Operations. Th...
  • 4/21/2024 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...
  • 4/21/2024 12:00:00 AM

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Quality Assurance Specialist
  • Axelon Services Corporation
  • Ayer, MA
  • Job Description: Field QA Specialist Devens, MA This role is 100% on-site. Work Schedule: Mon - Fri, 2PM - 10:30 PM EST ...
  • 4/20/2024 12:00:00 AM

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Operations Quality Assurance Specialist
  • Point32Health
  • Canton, MA
  • Under the direction of the Quality Assurance Supervisor, the Quality Assurance Specialist listens to and scores calls ba...
  • 4/20/2024 12:00:00 AM

Boston has an area of 89.63 square miles (232.1 km2)—48.4 square miles (125.4 km2) (54%) of land and 41.2 square miles (106.7 km2) (46%) of water. The city's official elevation, as measured at Logan International Airport, is 19 ft (5.8 m) above sea level. The highest point in Boston is Bellevue Hill at 330 feet (100 m) above sea level, and the lowest point is at sea level. Situated onshore of the Atlantic Ocean, Boston is the only state capital in the contiguous United States with an oceanic shoreline. Boston is surrounded by the "Greater Boston" region and is contiguously bordered by the citi...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Quality Assurance Specialist jobs
$68,929 to $87,267
Boston, Massachusetts area prices
were up 2.5% from a year ago

Quality Assurance Specialist in Mcallen, TX
Those interested in a Quality Assurance Specialist position should highlight in their resumes engineering experience, quality assurance knowledge, time management, and teamwork.
December 06, 2019
Quality Assurance Specialist in Lubbock, TX
When recruiting for a telemarketing quality assurance specialist, you’ll often find candidates weighted too far toward one skillset or the other, or even trying to transition from technology QA into telemarketing QA when they’re wholly different animals.
February 24, 2020
Quality Assurance Specialist in Wichita, KS
This is a great opportunity for someone who wants to be part of a growing business as a Quality Auditor and work in a great Technical team.
January 11, 2020