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Responsibilities

• Ensures that documentation is maintained/archived in accordance with internal procedures and regulatory requirements (i.e. GxP, etc.).
• Administration of company Electronic Document Management System. This includes but is not limited to supporting maintenance of the system's validated state, as well as configuring the system to meet new business and user needs.
• Compiles global regulatory submission certifications and documentation as required by business partners for ex-US submissions.
• Supports the review and approval of data and documentation for the preparation of Annual Product Review Reports (APRs).
• Provides support with product and process investigations and data analysis, as requested by Quality management.
• Utilizes knowledge of regulatory requirements to identify, describe and communicate issues and participates in problem resolution and corrections.
• Initiates, tracks, and provides support for problem resolution as required through the Quality Management System and notifies necessary departments of issues.
• Supports and maintains an environment that fosters communication and teamwork within Quality Assurance and related departments.
• Authors, revises and approves job related controlled documents.
• Maintains all accurate regulatory documentation.
• Provides guidance to personnel from a wide range of departments relative to documentation issuance, handling and archival, annual product reviews, MyQUMAS.
• Evaluates accuracy, completeness and adequacy of data/reports from internal and external sources.
• Maintain current knowledge base within relevant technical discipline of FDA regulations and awareness of the necessity and impact of compliance of the business.
• Organizes and facilitates activities for assigned projects as assigned.
• Communicates and participates in identified improvements as well as mitigation of potential gaps.
• Supports regulatory inspections, as requested.
• Performs other related assignments and duties as required and assigned.

Requirements:

• BS required for external candidates and 4 years minimum relevant experience, or equivalent level of experience in pharmaceutical or related industries; or graduate degree (MS preferred) with 2 years minimum relevant experience.
• A thorough understanding and working knowledge of Quality Systems and tools.
• Demonstrated sound understanding and well-developed working knowledge and ability in primary discipline.
• Knowledge of GxP and FDA regulations acquired through experience, training, or education; and awareness of impact on cross functional areas.
• The ability to effectively compile/report data and the ability to assist with administration of a Quality System is required.
• The incumbent reports to the Sr. Manager, Quality, Documentation Systems. The position has no direct supervisory experience over subordinates. The incumbent must:
• Possess the ability to independently prioritize workload.
• With minimal guidance and supervision, conducts routine and non-routine activities in the primary discipline with minimal guidance and supervision.
• With minimal guidance and supervision, plans, performs, and reports to management regarding QA and compliance activities.
• May interact with other departments/teams within the Company and with external regulatory agencies and business partners.