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QA/Validation Specialist

The QA Validation Specialist performs highly diversified duties that focus on validations, compliance audits, training, and method development for the Quality Assurance department.  Generates accurate records including protocols and reports evidencing completion of these activities.

Responsibilities

  • Supports conformance to regulatory requirements and generates internal documents to establish company procedures.
  • Performs equipment validations by performing testing, analyzing data, and writing reports.
  • Ensures that recording forms, inspections, and procedures are properly completed and documented.
  • Performs audits for Good Manufacturing Practices (GMP’s) and various regulatory compliance programs and prepares report of audit findings.
  • Coordinates and responds to audit activities in a constructive manner and uses findings to improve operations where possible.
  • Interfaces with all other departments in technical and regulatory matters.
  • Tracks and analyzes data to help ensure compliance with regulatory laws and specifications.
  • Documents protocols and diagrams in electronic format such as Visio or MS Office.
  • Contributes to an environment in which all team members are respected regardless of their individual differences and are motivated to improve both their individual and team contributions to achieve desired business results.
  • Performs duties in compliance with company policies, safety rules, SOP’s, and GMP’s.

Requirements

  • Bachelor’s degree in a technical or scientific skill or 3 years of experience in validation protocols or environmental health in a manufacturing environment.
  • Strong knowledge of general science or environmental health.
  • Strong mathematical and problem solving skills.
  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
  • Ability to write routine reports and operating procedures.
  • Strong interpersonal skills with the ability to influence others in a positive and effective manner.
  • Ability to meet deadlines in a fast-paced environment with a strong eye for detail.
  • Demonstrate a commitment to quality performance through personal example by adopting a customer-based philosophy in the level of service provided.
  • Must be able to follow verbal and written instruction and communicate clearly and concisely both in writing and verbally.
  • Ability to coordinate and collaborate with multiple departments and represent different points of view without long-term negative consequences.

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