Position Role & Responsibilities:

• Support the creation, revision, and maintenance of the company's controlled documentation.
• Format, track and issue controlled cGMP documents including protocols, batch records, labels, forms, and logbooks.
• Tracking of master batch records, tracking of all batch production records and reconciliation of labels issued.
• Help maintain the electronic Quality Management System (eQMS) in relation to document management, and assist with implementation of eQMS for Training.
• Assist in review of cGMP controlled documents as necessary
• Maintain an archive of completed files [paper and electronic] (batch records, validations, etc)
• Maintain and manage the tracking, quality and contents of satellite quality binders.
• Interface with other departments regarding documentation requirements.
• Participate in and support quality audits (internal and external) suppling approved procedures and completed records, as requested.
• Administer Biennial review process.
• Complete reconciliation of Controlled Documents.
• Perform additional job-related duties as required.

Requirements:

• Comprehensive knowledge in principles and practice of current Good Manufacturing Practices (cGMPs)
• Knowledge, experience, and application of good documentation practices (GDP)
• Contributing to authoring, revising, and reviewing of SOPs.
• Due to the nature of work, overtime and weekend work maybe required based on needs.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

Preferred Education and Experience

• A.A., B.S. in Sciences or related scientific field preferred. Equivalent direct experience is also acceptable as a substitute for formal education.
• 2-5 years' experience in manufacturing cGMP environment performing Quality Documentation / Training management duties preferred.

Additional Desired Skills and Knowledge:

• Solid experienced with computer skills in Microsoft Office (Word and Excel). In particular, formatting experience in Word is preferred.
• Detail oriented team player with effective planning, organization, and execution skills.
• The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems.
• The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision without neglecting attention to detail.
• The ability to enable and drive change while being focused on internal and external customers.
• Capability to manage multiple priorities.