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Quality Assurance Specialist

Company: Medical Science & Computing (MSC), a Dovel company
Location: Bethesda
Posted on: November 19, 2021

Job Description:

We are currently searching for a Quality Assurance Specialist to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC and it is on-site in Bethesda, Maryland. Duties & Responsibilities

  • Provide Quality Assurance input and oversight in aseptic processing/manufacturing facilities within the NIH.
  • Provide on-the-floor QA oversight in the cleanroom and laboratory environments and support to ensure compliance to GMP regulations and USP guidance throughout those areas.
  • Perform quality walk-throughs and process observations.
  • Review test methods and EM data.
  • Ensure timely resolution and escalation of issues within the operational areas.
  • Ensure products are manufactured in compliance with USP guidelines.
  • Ensure all product-related and facility Deviations are initiated, investigated and resolved.
  • Ensure that associated CAPAs are initiated and resolved, as needed.
  • Review and approve Change Control, Deviation, CAPA, as needed.
  • Generate and revise standard operating procedures and associated documents as needed.
  • Identify compliance risks and escalate the issues to appropriate levels of management for resolution.
  • Capture metric information for use in continuous improvement of areas of responsibility and report to management, as needed.
  • Conduct vendor qualification programs to support aseptic processing/manufacturing facilities within the NIH. Requirements
    • Bachelor's degree in Regulatory Science or related field.
    • 3 years of experience performing Quality Assurance functions in an FDA regulated facility (either a GMP facility or a Compounding Pharmacy).
    • Knowledge of the FDA regulations that cover manufacturing such as USP 797, USP 800, USP 823, FDA 21CFR211 and/or FDA 21CFR212.
    • Knowledge of the ISO requirements for a quality management system.
    • Experience authoring SOPs and trending and tracking of data. Due to our contractual requirements and federal orders, including an Executive Order from the White House and an emergency regulation from the Centers for Medicare & Medicaid Services (CMS), the position for which you are applying requires that you provide proof of your vaccination status. If you are unable to receive the COVID-19 vaccine for medical reasons or because of a sincerely held religious belief, you may request an exemption from the vaccination requirement which shall be reviewed after the submission of requested documentation. If an accommodation is granted, the conditions may include weekly testing and masking. All Guidehouse employees also agree to follow any additional health and safety mitigation policies that may be required in the workplace. #LI-GH1 Company Description We are a trusted government partner that blends deep domain expertise with advanced technologies to help our customers solve complex problems that improve, protect, and save lives. As a rapidly growing company, we combine entrepreneurial spirit, customer focus, and an outcomes-based approach to support agency missions in health IT, life sciences, public safety, and grants management. The Dovel Family of Companies offers employees an opportunity to advance beyond a specific role or contract, we offer a path to develop an enriching career. We believe in empowering a culture of innovation, customer success, and employee growth. What you'll get---
      • Time Off! Flexible schedules and company paid holidays allow you to take the time you need.
      • Investment in YOU! 401(K) company contributions are yours to keep with no waiting period.
      • Choices! Unique healthcare plans to choose from with options like fertility and orthodontia benefits.
      • Discovery! With our tuition assistance and training programs, we support your career advancement.
      • Tax Savings! Enroll in pre-tax Health or Dependent Care Flexible Spending, HSA with company contributions, parking, and/or transit commuter benefits.
      • Support! Working parents and busy professionals - we've got you covered with a supportive culture, confidential Employee Assistance Program and a membership to Care.com.
      • Perks! Employee discounts, peer recognition programs, company-wide wellness challenges, and fun community events.
      • A Voice! A unique culture where you can influence decisions and have your voice heard. We are an Equal Opportunity Employer with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, disability, or veteran status.

Keywords: Medical Science & Computing (MSC), a Dovel company, Bethesda , Quality Assurance Specialist, Other , Bethesda, Maryland

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