Quality Assurance Specialist

Location
Bethesda, MD
Posted
Aug 11, 2020
Closes
Sep 19, 2020
Ref
225979
Function
Administrative, Other
Industry
Other
Hours
Full Time
Job Summary/Company: Our client, a medical sciences company that partners with various federal agencies, is looking for a Quality Assurance Specialist to join its team. If you have a background in regulatory science and quality assurance functions in a FDA-regulated facility, please submit your resume and give us a call at 202-463-5100.

Responsibilities:
  • Provide Quality Assurance input and oversight in a hospital compounding Pharmacy. Perform quality walk-throughs and process observations.
  • 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.
  • Ensure products are manufactured in compliance with USP guidelines; and that all product-related and facility Deviations are initiated, investigated and resolved
  • 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.
Qualifications/Background Profile:
  • Bachelor's degree in Regulatory Science or related field required.
  • At least 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.
  • Experience authoring SOPs and trending and tracking of data.


Qualified candidates should send their resume AND call Sparks Group for additional details. Please note, resume must include a valid email address in order to be considered. We look forward to discussing your background, your current job search, and your potential career path with Sparks Group!

Sparks Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, pregnancy, citizenship, family status, genetic information, disability, or protect veteran status.

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