Document Control Analyst

Job Description

Job Description

The Document Control Analyst (DCA) plays a key role in managing and maintaining critical documentation that supports Laboratory Operations, Research & Development, Pathology, and Regulatory functions within a collaborative, cross-functional environment. Reporting to the Quality Department, the DCA helps ensure compliance with laboratory certification standards, internal Standard Operating Procedures (SOPs), and quality systems requirements as defined by U.S. and international regulatory bodies. The DCA requires proficiency in both paper- based and electronic document control systems, as well as a continuous improvement mindset, offering recommendations to enhance quality and document control processes across the organization.

Job Responsibilities:

• Utilize electronic Quality Management System (eQMS) to manage documentation in compliance with ISO standards and company procedures.
• Maintain a secure, traceable, and compliant documentation system for SOPs, validations, training records and related documents.
• Create, issue, and manage logbooks used throughout the company.
• Ensure periodic reviews of documents to maintain alignment with customer requirements, internal procedures and process improvements.
• Ensure document structure and content comply with ISO standards, cGxPs, and company policies
• Support the creation and refinement of QMS procedures and work instructions.
• Collaborate cross-functionally with teams to develop, review and release-controlled
• Manage document change control processes, including routing, approval, and electronic signatures (e.g., via DocuSign).
• Provide document control oversight, ensuring accuracy, completeness, and compliance with cGxP requirements.
• Support internal customers by addressing documentation-related issues and driving solutions.
• Develop and implement communication strategies to track and prioritize document-related projects.
• Drive continuous quality improvement projects
• Identify and escalate quality issues and collaborate on effective resolutions.
• Oversee the collection, organization, storage and retrieval of both paper and electronic documents.
• Administers the document lifecycle: creation, approval, publication, revision, retirement and archival.
• Prepares and update document templates and assist in scanning and digitizing paper records
• Maintains the master document database.
• Maintain the master document database and ensure documentation is readily accessible to authorized personnel.
• Performs or support audits of document control processes to ensure ongoing compliance.
• Perform additional duties as assigned.

Knowledge, Skills & Experience:

• 1-2 years of experience in a regulated Quality Assurance or Quality Control environment required.
• Experience with electronic systems such as eQMS, SAP, Microsoft SharePoint, Microsoft Teams.
• Prior experience managing Document Control activities in a regulated industry is preferred.
• Familiarity with quality systems such as ISO 13485 and 21 CFR 820 is preferred.
• Working knowledge of and adherence to Standard Operating Procedures (SOPs) in alignment with company policy and Quality Manual.
• Consistent compliance with all company safety protocols.
• Demonstrated ability to work independently, manage multiple priorities, and thrive in fast-paced, dynamic
• Strong written and verbal communication skills, capable of engaging with all levels of the organization.
• Demonstrated problem-solving and interpersonal
• Proficient with Windows OS and Microsoft Office Suite (Word, Excel, and Power Point).
• Skilled in data collection, organization and accuracy.
• Comfortable navigating various software platforms and document control
• Excellent attention to detail and organization skills.
• Proven ability to thrive in collaborative, team-based environments, including participating in peer reviews and sharing information across departments.

Education, Certification & Licensures:

• Associate degree in technical or business-related field is required
• Bachelor's degree preferred
• Relevant professional experience may be considered in lieu of a formal degree.

Other:

• Ability to use copiers, fax machines, binding machine and PDF scanners to keep inventory and ordering records. Visual acuity and analytical skill to distinguish sufficient detail.
• Must possess the ability to sit or stand for long
• Must possess the ability to perform repetitive
• Ability to lift up to 25
• May have exposure to biohazardous material in the lab
• Exposure to xylene, DAB, and alcohol, which emit The xylene, and DAB are carcinogenic.
• This position is based at the Company's Scottsdale, AZ headquarters and is expected to spend 70% of time on site (with flexibility for limited remote work during each week as determined with manager)