The Quality Specialist is responsible for performing multiple activities in support of their group or clients under minimal supervision. The Specialist applies technical proficiency and attention to detail in "troubleshooting," as well as the ability to interpret and execute project plans and lead initiatives with minimal guidance.

GENERAL RESPONSIBILITIES AND REQUIRED SKILLS:

In addition to the attributes of a Quality Specialist:

• Presents a solid understanding of quality assurance concepts and practices
• Demonstrates knowledge of applicable regulations and the interpretation and application of regulations and compliance concepts related to document control
• Presents a solid understanding of both digital and paper document control best practices
• Exercises independent judgment to optimize compliance procedures and identify opportunities for continuous improvement
• Able to manage and anticipate client expectations
• Displays effective communication skills (written and verbal), within their area(s) of expertise
• Demonstrates proactive thinking and actions
• Responsible for reviewing and authoring SOPs and Work Instructions, with minimal supervision
• Acts as a representative of their Quality division on assigned project sub-teams and/or task forces
• Demonstrates proficiency in influencing others within project teams regarding quality or compliance concerns
• Displays an ability to develop innovative ideas for solving problems
• Displays solid organizational and project management skills
• Has the ability to read and respond to audiences appropriately
• Performs other duties as assigned

In addition to Quality Associate Responsibilities:

• Independently manages the full life cycle of the Document Control processes including

• Maintain GXP archives, including receipt, processing and storage of GXP records.

• Facilitate the lifecycle of controlled documents in the electronic document management system (document creation, revision, issuance, and obsolescence)
  • CMC Documents (Master Batch Records, Analytical Methods, Specifications, etc.)
  • QA Controlled Documents (Standard Operating Procedures, Work Instructions, etc.)
  • Document Distribution (including batch record and logbook issuance)

• Interacts with internal and external customers and functional groups at various management levels to provide excellent customer service

• Associate Degree and 2 - 5 years of relevant work experience, or
• relevant comparable background