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Quality Assurance Specialist

Norfolk, VA

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Remedy Professional Placement is seeking a Quality Systems Specialist for a local Biotech manufacturing company in Norfolk, Virginia.

The Quality Systems Specialist will be a highly motivated individual, self-started with an A+ attitude and proven ability to follow through who will be involved in managing agile/lean operations. The position will manage a number of tasks and projects simultaneously. This position will be responsible for performing diverse responsibilities requiring sound judgment, problem solving skills and a working knowledge of all GXP quality systems.

Requires a good working knowledge, comprehension, and experience with quality systems, measuring techniques and equipment in a regulated (GMP) environment. Strong verbal, written and technical skills required. Able to work with minimal supervision, demonstrate initiative and self-direction. Ability to collaborate and assist with solving practical problems. Strong interpersonal skills including teamwork, listening and giving feedback are required.

Principle Duties:

  • Provide leadership to and manage the daily activities of the QA Systems and Compliance.
  • Demonstrate leadership by ensuring the continuous improvement of the Quality Management Systems,
  • Manage the Internal and External Audit programs to ensure Suppliers are in compliance with applicable regulations.
  • Formulate and implement the Business’ long-range quality and compliance policy.
  • Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction
  • Works in partnership with Manufacturing, Engineering, Maintenance and Quality in designing and enhancing Quality Management Systems to facilitate overall regulatory compliance and conformity to ISO 9001 requirements.
  • Develops and maintains internal audit plans
  • Non-Conforming Events, Corrective and Preventive Actions (CAPA), Training
  • Document Control, Management Controls, Internal Audits.
  • Manage multiple Global Quality Systems functions including but not limited to: Non-Conforming Events, Corrective and Preventive Actions (CAPA), Training; Document Control, Management Controls including Management review and Quality Planning; Internal Audit Programs
  • Take initiative to liaise with external QMS consultants and regulatory counsel to confirm sufficiency of quality systems and documentation


  • Experience in managing external Audits, Customer, ISO and/or FDA Inspections
  • Proven ability to collaborate with all levels/functions in executing quality objectives
  • Technical and business writing and presentation experience and delivery
  • Bachelor’s degree or higher in relevant field
  • Track record of meeting deadlines and goals
  • LEAN manufacturing experience preferred 
  • Strong problem solving and analytical skills
  • Multi-tasking and prioritizing responsibilities

V3 Certified 


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