Quality Document and Change Specialist

Description

Position Summary & Responsibilities:

This Quality Specialist role is responsible for supporting representation for quality related change projects, tracking risk mitigation requirements, and required project collaborations for clear communication. In this role you will be responsible for processing and tracking document revisions, change controls, departmental trending, and some system admin oversight.

• Utilization of LLDC Document System and Trackwise to process revisions and changes
• Serve as a contact for quality related departmental projects for reagents and instruments (equipment, expansions, testing, etc.)
• Utilize project management tools to maintain organized records of action items
• Collaborate with SMEs in departments to maintain clear oversight to project requirements, impacted documents or procedures, and project costs.
• Support utilization of risk management skills to identify and address impacts to projects

Education, Skills, & Experience:

• Bachelors degree with 3+ years of GMP experience
  • Associates degree with 5+ years of GMP experience also accepted
  • High School Diploma or GED with 7+ years of progressively responsible and related GMP experience also accepted
• Experience working in a FDA production environment
• Prior knowledge of MES, SPC, or SAP a plus
• Strong PC skills including proficiency in Excel, PowerPoint, Outlook, Word, Visio, and Project
• Exhibits strong analytical and problem-solving skills. Clearly expresses ideas (verbal and written) and demonstrates the ability to utilize quality system tools and techniques effectively.
• Strong time management skills and accountability
• Familiarity with relevant domestic and international regulations and industry standards (e.g. ISO, FDA QSR).
• Strong interpersonal skills and ability to work with all levels of an organization.

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