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QA Document Control Specialist
2 months ago
Join Our Team as a Document Control and Records Management Specialist
Are you passionate about ensuring compliance and maintaining high standards in document management? Do you thrive in a fast-paced environment and have excellent organizational skills? If so, we have the perfect opportunity for you As a Document Control and Records Management Specialist, you will play a crucial role in maintaining documents in compliance with business needs and regulatory expectations. You will support process improvements and manage both paper-based and electronic document workflows. Join us and be a part of a dynamic team that values precision, efficiency, and continuous improvement.
Summary:
The Document Control and Records Management Specialist will be responsible for maintaining documents in compliance with business needs and regulatory expectations, and supporting process improvements in these areas. The individual will manage paper-based and electronic document workflows, including chain of custody, issuance, review, and archival of records. Excellent organizational skills, the ability to work independently on multiple tasks, and the ability to thrive in a fast-paced environment are required.
Key Responsibilities:
Support teams in document requests, approvals, and archivals.
Issue and reconcile paper records.
Manage on-site and off-site GMP document archival.
Implement process improvements for document control and records management.
Assist in enhancing document control processes in eDMS.
Perform non-technical document reviews.
Revise SOPs related to Document Control and Records Management.
Identify efficiencies in paper-based document maintenance.
Support internal/external audits and inspections.
Ensure compliance with GxP regulations and company policies.
Follow Good Documentation Practices and Data Integrity requirements.
Complete required training on time.
Required Background:
Education: BS or MS degree, preferably in Sciences or Engineering.
Experience: 7-10 years of Quality Assurance experience in the pharmaceutical industry OR BS degree with 2-5 years of experience/MS degree with 2 years of experience.
Demonstrated aptitude or ability to learn and gain a strong understanding of GxP regulations (including GMP, GLP, GCP, GVP, or other applicable standards).
Join us and make a difference in ensuring the integrity and compliance of our document management processes. Your expertise will help us maintain the highest standards and support the success of our business operations.
