Job Description

We are seeking a highly organized and proactive Document Control and Records Management Specialist to join our team. This position is crucial in ensuring the accuracy and compliance of document workflows, both paper-based and electronic, in alignment with business needs and regulatory requirements. As part of the team, you will help drive process improvements in document control and records management, supporting a fast-paced and dynamic environment.

Key Responsibilities:

• Support cross-functional teams in processing document requests, approvals, and archival.
• Issue and reconcile paper records such as batch records, logbooks, and protocols.
• Manage the archival of all GMP documentation, both on-site and off-site, including maintaining the on-site archival room.
• Implement and develop process improvements for Document Control and Records Management processes.
• Assist in optimizing document control processes, including document types, lifecycles, and workflows in eDMS.
• Revise SOPs related to Document Control and Records Management.
• Collaborate with cross-functional teams to identify efficiencies in the management of paper-based documents.
• Provide support for internal and external audits and inspections, ensuring documentation is in compliance with regulatory and internal requirements.
• Adhere to Good Documentation Practices (GDP) and Data Integrity requirements for documentation, records, and data management.
• Complete all assigned training according to the required timelines and requalification cadence.
• Additional duties as assigned to support the department’s goals and objectives.

Basic Qualifications:

• Education: BS or MS degree in a relevant field, preferably in Sciences or Engineering.
• Experience: 7-10 years of Quality Assurance experience in the pharmaceutical industry, or a BS degree with 3-5 years of experience, or an MS degree with 2 years of experience.

Preferred Qualifications:

• Strong understanding of GxP regulations (including GMP, GLP, GCP, GVP, or other applicable standards).
• Demonstrated ability to implement process improvements and drive efficiency in document control and records management.
• Desire to contribute to a high-growth, transformational company that values boldness, relentlessness, curiosity, and collaboration.
• Must be able to work on-site full-time at [Company Name]'s location. This position is not eligible for remote work.

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