The Quality Systems Associate - Document Control will join our client and bring their knowledge and experience in service to patients and pursue excellence in quality and compliance. Responsibilities of the position include ensuring consistent application of regulatory expectations to documents and the management of applicable repositories, managing the document change control process, and aiding other personnel in utilizing the document control system.
Essential Duties And Responsibilities
Responsible for maintenance of the Document Control System and execution of applicable program activities, acting as the site's subject matter expert on document control.
Coordinates document control and training timelines.
Oversees Periodic Review Timeliness
Performs Impact Assessments for Document Change Controls.
Coordinates and performs training verification
Performs True Copy verification
Ensuring all GMP documentation is maintained and controlled per company policies and procedures, including issuance and reconciliation of controlled copies.
Authors procedural documents related to area of responsibility.
Interpreting compliance and regulatory requirements for incorporation into departmental systems, procedures, and documentation.
Track, trend, and analyze Document Control System metrics for the site.
Developing collaborative relationships with end users and providing guidance on standard processes in document control.
Support overall quality system programs as needed to include but not limited to training, supplier quality, change control, and deviation/CAPA systems.
Support cGMP compliance and inspection readiness within the organization.
Fosters the development of a Quality Culture within the cGMP environment.
Practice and promote a safety and quality mindset and quality excellence approach to all activities.
Facilitates document establishment and revision through management of Document Change Requests and Document Change Controls.
Participation in the editing and reviewing of controlled documents, ensuring adherence to applicable internal procedural and external regulatory requirements.
Basic Qualifications And Capabilities
Bachelor's degree with a minimum of 2 years of experience or a combination of 8 years of education and experience in document control and training within a regulated industry.
Strong organization and execution skills with a proven track record of successfully managing multiple projects and priorities.
Excellent interpersonal and written communication skills and experience using various software/electronic applications required.
Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment.
Ability to work autonomously and within established guidelines, procedures, and practices.
Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
Continuously looking for opportunities to learn, build skills, and share knowledge with others.
Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
Previous document control and training administration experience within the Pharmaceutical Industry.
Previous experience working with Veeva or other electronic document and training management systems.
Previous experience writing and/or revising Standard Operating Procedures.