Quality Assurance Specialist jobs in Wilson, NC

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 assurance specialist
  • Merck
  • Durham, NC FULL_TIME
  • Job Description

    Our Quality Assurance group ensures all materials inside our products and the products themselves are manufactured, tested, and distributed in alignment with our high standards of quality.

    Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers, we create an interdependent global manufacturing network committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

    Our Company will construct a new manufacturing facility to significantly expand its production capacity for a medicine for the treatment of certain forms of bladder cancer.

    Global demand has outpaced our current maximum manufacturing capabilities. Once this new facility is fully operational, we will triple our current manufacturing capacity, which is expected to support the anticipated demand for the foreseeable future.

    This investment reaffirms our Company’s longstanding commitment to producing this medicine for the patients who need it.

    The facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.

    The Quality Assurance Specialist will support this expansion. Project activities requiring support include the capital project to construct the facility, process and technology introduction, compliance improvements, and manufacturing readiness to initiate production of commercial product.

    The focus for the position includes all aspects of Quality oversight for drug product, drug substance, media preparation, and sterile supply.

    Position Responsibilities :

    Reporting to the Quality Assurance Organization, will independently manage project assignments.

    Ensure individually assigned aspects of the project proceed in compliance with cGMP, regulations, and our Company’s Quality Management System.

    Supporting areas such as Design, Commissioning, Qualification and Compliance covering Manufacturing Equipment (isolator, restricted access barrier, incubator, washer, autoclave, formulation vessel, lyophilizers, etc.).

    Provide QA shop floor support in the execution and review of GMP documentation such as IQ, OQ and other technical documents to meet schedule milestones.

    Provide QA shop floor support on batch review, alarm response, incursion response and deviation management.

    Provide QA shop floor support on Aseptic techniques, aseptic observations, cleaning techniques, and gowning observations.

    Partner with site functions to solve problems and achieve goals.

    Makes decisions guided by policies and procedures that impact the team’s ability to meet performance objectives.

    Consults on an as-needed basis with next level manager on more complex decisions.

    Education Minimum Requirement :

    Bachelor's and / or Master’s (or other advanced) Degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline.

    Required Experience and Skills :

    With Bachelor’s Degree, at least 3 years of experience in the pharmaceutical industry or highly regulated industry.

    With Master’s (or other advanced) degree, at least 1 years of experience in the pharmaceutical industry or highly regulated industry.

    At least 1 year of experience in aseptic manufacturing or other clean room environment .

    Strong contemporary knowledge of relevant current good manufacturing practices (cGMPs), regulations and current industry trends.

    Effective decision making, problem solving and communication skills. Ability to manage multiple priorities.

    Demonstrated ability to work in fast-paced, complex environments and escalate appropriately.

    Schedule : Monday - Friday, 6 AM - 2 : 30 PM EST. (May include weekends and holidays)

    Preferred Experience and Skills :

    GMP quality experience with biological drug substance or drug product.

    GMP experience with qualification of equipment.

    Experience with Quality Risk Management.

    Project Management experience in a highly regulated industry.

    Experience with Kneat, SAP, Veeva and / or GLIMS.

    Experience in deviation management with focus on quality review and approval.

    Experience in Aseptic processing, aseptic observations, and techniques.

    Electronic manufacturing batch records (eMBR) experience.

    In accordance with all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

    If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package.

    To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. VETJOBS #EBRG

    Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).

    Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated.

    Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

    Last updated : 2024-03-03

  • 23 Days Ago

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Quality assurance specialist
  • Novo Nordisk
  • Clayton, NC FULL_TIME
  • About the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-cha...
  • 24 Days Ago

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Quality assurance specialist
  • Novo Nordisk A/S
  • Clayton, NC FULL_TIME
  • About the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-cha...
  • 24 Days Ago

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Quality assurance specialist
  • Amgen
  • Holly Springs, NC FULL_TIME
  • HOW MIGHT YOU DEFY IMAGINATION? Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion ...
  • 2 Days Ago

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Quality Assurance Specialist
  • Cliff IT Solutions Inc
  • Sanford, NC CONTRACTOR
  • Hello,We are hiring for a Quality Assurance Associate/Specialist for one of our prominent client based at Sanford, NC Below are the details: This is a 12 months contract job.Responsibilities: The Sanf...
  • 3 Days Ago

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Quality Assurance Specialist (USA)
  • Poppies Bakeries
  • Battleboro, NC FULL_TIME
  • USA Battleboro Quality / R&D This is what your day will look like: You assist with the establishment, development, and management of the quality department at the production plant. You ensure product ...
  • 9 Days Ago

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0 Quality Assurance Specialist jobs found in Wilson, NC area

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Quality Assurance Inspector
  • Draken
  • Kinston, NC
  • At Draken, we have created a new standard in aviation service capabilities for all branches of the United States Militar...
  • 3/28/2024 12:00:00 AM

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Quality Assurance Manager
  • Lennar Corp.,
  • Raleigh, NC
  • Overview Summary of Position Requirements: The Quality Assurance Manager is responsible for inspecting and evaluating th...
  • 3/28/2024 12:00:00 AM

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QA/Expeditor - Garner Chili's - No Experience Required
  • Brinker International
  • Garner, NC
  • Role Overview Our Quality Assurance Specialists ensure each Guest receives perfectly prepared, high-quality food. They p...
  • 3/27/2024 12:00:00 AM

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Quality Assurance Specialist
  • Advanced Recruiting Partners
  • Raleigh, NC
  • Position Background: The Quality Specialist II provides support to the overall Quality Assurance program at the site. En...
  • 3/25/2024 12:00:00 AM

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Quality Assurance Supervisor
  • Synerfac
  • Nashville, NC
  • Details: QA Supervisor Summary We are looking for a detail-oriented and proactive Quality Assurance Supervisor to overse...
  • 3/25/2024 12:00:00 AM

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Quality Assurance Intern
  • Catalent, Inc.
  • Greenville, NC
  • Quality Assurance Intern The Position Catalent's Greenville, N.C. facility specializes in end-to-end turn-key solutions ...
  • 3/25/2024 12:00:00 AM

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Quality Assurance
  • eTeam, Inc.
  • Cary, NC
  • Position NameQA The role is a combination of manual testing and automated testing for web and native iOS/Android mobile ...
  • 3/24/2024 12:00:00 AM

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Director, Quality Assurance
  • Envestnet
  • Raleigh, NC
  • Envestnet is seeking a passionate and talented Director, Quality Assurance to join our technology team. This position is...
  • 3/24/2024 12:00:00 AM

Wilson is a city in and the county seat of Wilson County, North Carolina, United States. Located approximately 40 mi (64 km) east of the capital city of Raleigh, it is served by the interchange of Interstate 95 and U.S. Route 264. Wilson had an estimated population of 49,610 in 2012, according to the Census Bureau. In the early 21st century, Wilson was ranked as 18th in size among North Carolina’s 500-plus municipalities. From 1990 to 2010, the city population increased by more than 40 percent, primarily due to construction of new subdivisions that attracted many new residents. This has been ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Quality Assurance Specialist jobs
$59,334 to $75,117
Wilson, North Carolina area prices
were up 1.5% 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