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Quality Specialist

Company: Avantor
Location: Morrisville
Posted on: January 24, 2023

Job Description:

Job SummaryUnder moderate supervision, responsible for technical quality tasks, including inspecting and processing raw materials and reviewing and releasing finished products. Perform Batch Record Review and manufactured product release processing. Observe cGMP good documentation practices.Available Shift? Monday - Friday, 7:30am to 4:00pm
Why Avantor?

  • Full-Time Health Benefits on Your First Day
  • Sign-On Bonus
  • Quarterly Incentive Bonuses paid
  • Competitive Time off Package (PTO and Holidays)
  • Employee Stock Options
  • Retirement Plan Options with company match
  • Direct HireWhat does the position do?
    • Follows company policies, procedures, work instructions, and training requirements focusing on customer service, production, and quality.
    • Keeps customer interests and regulatory requirements in mind, ensures customer needs are met by reviewing order requirements, customer documentation requirements, proper filling and assembly requirements, and, where needed, ensures other technicians understand and follow documented VWR Solon procedures and GMP requirements.
      • Ensures customer requirements are met.
      • Verifies adherence to policies, procedures, and work instructions.
      • Ensures documentation and physical product segregation and containment of non-conforming material identified during the production process.
      • Reviews production documentation for accuracy, completeness, and GDP compliance.
      • Assists in correcting order issues and ensures actions that are taken are appropriate.
      • Communicates issues / concerns to area owner and direct manager.
      • Ensures that the area is in a state of "audit readiness" at all times.
      • Performs inspection tasks by following established work instructions and procedures, by using required tools and methods and, when applicable, equipment, to determine acceptability of product, components, and documentation.
      • Performs pre-fill, in-process, and final inspections with the aid of documented work instructions and inspection information as the need arises.
      • Stops production when a non-conformance (NCM) is observed and follows appropriate NCM procedures.
      • Documents non-conformances following applicable VWR Solon procedures and work instructions.
      • Documents and trends any quality production issues discovered during the course of inspection duties.
      • Ensures cleanliness of work areas during the inspection processes.
      • Applies problem solving tools such as 5M+E, 5 Why's, or other root cause analysis tools / methods to identify and permanently resolve issues.
      • Adheres to VWR Solon's QMS and VWR Policies, where applicable.
      • Walks the floor to observe, train, and facilitate / support change.What do you need to have?
        • High School completion or equivalent (GED) and a minimum of 3 years related experience and/or training in a regulated industry is required; OR
        • Bachelor's degree is required
        • Experience in a Quality Assurance role within the medical device, biotech, or pharmaceutical industry is preferredWhat would be nice to have?
          • Must be able to balance multiple tasks and prioritize efficiently
          • Knowledge of ISO 9001, ISO 13485, 21 CFR 820, 21 CFR 11, ISO 17025, or EXCiPACT standard
          • Demonstrated experience or knowledge in conducting root cause analysis as it relates to nonconforming material investigations
          • Knowledge and experience using Microsoft Outlook, Word, Excel, and Access, or equivalent software packages
          • Good interpersonal skillsWhat's the environment like?
            • Works on the production floor with adequate lighting and ventilation with occasional elevated noise levels and a varying range of temperatures.
            • Work assignments are diversified.
            • Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.
            • A frequent volume of work and deadlines impose strain on routine basis.
            • Minimal physical effort is required; however, the position does require frequent walking, standing, bending, reaching, lifting or possibly carrying objects weighing up to 50 lbs.
            • While performing the duties of this Job, the employee is occasionally exposed to fumes or airborne particles and toxic or caustic chemicals.DISCLAIMER:
              The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
              Avantor is proud to be an equal opportunity employer.EEO Statement:We are an Equal Employment/Affirmative Action employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.For more information about equal employment opportunity protections, please view the Equal Employment Opportunity is THE LAW Poster, EEO is the Law Poster Supplement, and Pay Transparency Non-Discrimination Provision using the links below.EEO is the LawOFCCP EEO SupplementPAY TRANSPARENCY NONDISCRIMINATION PROVISION3rd Party Non-Solicitation Policy:By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation.

Keywords: Avantor, Cary , Quality Specialist, Other , Morrisville, North Carolina

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