Job Overview
The QA Documentation Controller is responsible for managing, organizing, and maintaining quality assurance (QA) documents. The role involves ensuring that all documents related to quality control processes, standard operating procedures (SOPs), and compliance are up to date, accurate, and readily accessible. This role is critical for supporting quality assurance efforts, regulatory compliance, and continuous improvement within the organization.
Key Responsibilities
* Document Management:
o Maintain and manage all QA-related documents, including SOPs, work instructions, manuals, batch records, specifications, certificates, and regulatory documents.
o Ensure documents are correctly formatted, filed, and archived in line with internal protocols and regulatory requirements.
o Establish document control processes, including version control and document approvals.
* Compliance:
o Ensure that all controlled documents comply with relevant standards (e.g., ISO, GMP, FDA) and regulatory requirements.
o Monitor the distribution and access of documents to ensure they are used appropriately by authorized personnel.
o Assist with internal and external audits by ensuring documentation is available and compliant with standards.
* Review and Updates:
o Regularly review and update documents to ensure they reflect current processes and regulations.
o Collaborate with relevant departments to ensure accurate and timely document revisions.
o Track document change control and maintain historical document versions.
* Training and Support:
o Train staff on document management systems, procedures, and regulatory requirements related to documentation.
o Provide support to staff in locating and accessing quality-related documentation.
* Reporting:
o Generate reports on document control activities and compliance status for management review.
o Track key metrics related to document control, including audit outcomes and process improvements.
* System Management:
o Oversee the use and maintenance of electronic document management systems (EDMS) and ensure data integrity.
o Set up user access, permissions, and workflows for document approvals and distribution.
Qualifications and Skills
* Education:
o Bachelor’s degree in Quality Assurance, Engineering, Life Sciences, or related field. (Experience may compensate for educational requirements.)
* Experience:
o Minimum of [X] years of experience in document control or quality assurance in regulated industries such as pharmaceuticals, medical devices, manufacturing, etc.
o Experience with electronic document management systems (e.g., SharePoint, MasterControl, Q-Pulse) is preferred.
* Skills:
o Strong organizational and attention-to-detail skills.
o Excellent communication skills, both written and verbal.
o Proficiency in Microsoft Office Suite and familiarity with QA and compliance software.
o Knowledge of regulatory standards (ISO, FDA, GMP, etc.) and documentation best practices.
o Ability to manage multiple tasks and prioritize workload effectively.
* Other Competencies:
o Analytical mindset with the ability to identify gaps in documentation processes and recommend solutions.
o Strong problem-solving skills and adaptability to handle evolving compliance standards.
o Collaborative attitude, working effectively across teams to ensure quality objectives are met.
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