Quality Assurance, Material Introduction Specialist

Overview
This position supports introduction of Active Pharmaceutical Ingredients (API), Excipients, Chemicals, and non-chemical components to Renaissance quality information systems (QIS/LIMS). Applying a current knowledge of regulatory requirements and practices of industry. The incumbent works with various departments such as engineering and validations to execute introduction of APIs, Excipients, Chemicals, and non-chemical components. Will provide accurate updates to team members, managers, and other business unit personnel. Ensure Standard Operating Procedures are maintained and applied. To participate in process improvement and to maintain the retention of the cGMP documentation required for component introduction
Responsibilities

• Implement new Active Pharmaceutical Ingredients, Excipients, Chemicals, and non-chemical component specifications.
• Revision of Active Pharmaceutical Ingredients, Excipients, Chemicals, and non-chemical component specifications.
• Participate in process improvements and projects within the company.
• Review documents for compliance with company standards for formatting, review, approvals, and implementation.
• Create and maintain procedures for document workflow, document retention, archiving and retrieval.
• Maintain documentation within L drive under appropriate folders.
• Attends client/project calls.
• Initiate Change Controls in Trackwise for the introduction of Active Pharmaceutical Ingredients, Excipients, Chemicals and non-chemical components, revisions to effective specifications and LIMs standards, and revisions to other documentation as necessary, and ensuring that action items are closed within project timelines.
• Initiate Change Controls in Trackwise for updates to industry guidelines.
• Generate quality standards based on understanding of industry guidelines.
• Work with Purchasing and Project management on obtaining source documentation required for introductions.
• Review vendor documentation for Chemicals and non-chemical components to ensure all required documentation is present and complete.
• Communicates key information to project management to assist with project timelines
• Any other tasks as requested by management.

Communications

• • Effectively interact with other scientists, engineers, validations, project managers and colleagues from numerous functions. Serve on multi-disciplinary project teams.
  • Effectively communicate progress, delays etc., to the manager, upper management, members of other business unit and clients.

Qualifications
Bachelor's degree required or equivalent work experience
Entry level - no experience required. Prefer at least 2 years of relevant experience in the pharmaceutical industry and experience with GMP documentation review, Quality Systems, and Health Authority Regulations.