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Quality Assurance Systems Specialist
2 months ago
Role: Quality Systems Coordinator
The Quality Systems Coordinator plays a crucial role in overseeing documentation processes to ensure compliance with our stringent standards and regulatory requirements. The successful candidate will exhibit meticulous attention to detail, outstanding organizational capabilities, and a commitment to upholding the integrity of all documentation activities.
Key Responsibilities:
- Manage and uphold the document control system (both electronic and physical), ensuring all records are current and readily accessible.
- Facilitate the approval process for documents through the Quality Management System (QMS) to the relevant reviewers and approvers.
- Assign training obligations within the QMS and ensure documents are published for user access.
- Supervise the organization and review of incoming documents to guarantee compliance with established company standards.
- Collaborate with various departments to enhance document workflows and increase operational efficiency.
- Conduct routine audits to verify the accuracy and completeness of documentation and naming conventions.
- Provide guidance to staff on document control protocols and best practices.
- Assist the internal Quality Assurance team with administrative tasks as required.
- Organize, format, and update Standard Operating Procedures (SOPs) related to Document Management.
- Effectively prioritize multiple tasks on a daily basis and promptly address any issues.
- Perform additional duties as assigned.
Qualifications:
- Bachelor's Degree with a minimum of 2 years' experience in a pharmaceutical or FDA-regulated environment.
- At least 1 year of experience in Quality Assurance or quality systems management within a GMP setting.
- Proficiency in MS Word, Excel, PowerPoint, and other relevant applications.
- Excellent written and verbal communication skills.
- Able to communicate and work independently with scientific and technical personnel.
- Experience with Quality Management Systems is preferred.
