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Quality Assurance Specialist

4 weeks ago

Winchester, Virginia, United States Aditi Consulting Full time
Job Summary

We are seeking a highly motivated and detail-oriented Quality Assurance Associate to join our team at Aditi Consulting. The successful candidate will be responsible for ensuring the quality and compliance of our manufacturing processes and products.

Key Responsibilities
  • Recommend and implement changes to Standard Operating Procedures (SOPs) and batch records as needed to ensure compliance with regulatory requirements.
  • Review and provide feedback on proposed SOP revisions to management.
  • Conduct real-time audits of batch records in production suites to ensure completeness, documentation, and conformance to critical process parameters.
  • Perform room and equipment clearances, microbial swabbing, and routine testing of in-process and finished product samples.
  • Monitor production manufacturing areas for compliance with SOPs, cGMP, and safety requirements.
  • Work cross-functionally to assess the impact of potential deviations and assist in identifying if an investigation is required.
  • Initiate deviation problem reports in Trackwise for issues discovered by QA.
  • Manage quality status of WIP and finished good materials on physical inventory and in the inventory system.
Requirements
  • Preferred: Bachelor's Degree in a related science or technical field in combination with 2 years of prior relevant work experience.
  • Minimum: High School Diploma in combination with 4+ years of relevant work experience in a regulated GMP manufacturing environment.
  • Additional qualifications desired: Lean Six Sigma, ASQ certification, or other professional certifications.
What We Offer

Aditi Consulting offers a competitive pay rate range, medical, dental, vision, PTO benefits, and ancillaries for eligible employees. We use AI technology to engage candidates during the sourcing process, but human-based decision making is used in employment decisions.