Job Description

Position Title: Document Controller / Sr Document Controller

Summary: The Document Controller / Senior Document Controller plays a pivotal role in overseeing the corporate documentation control system within a biotech environment. This position is responsible for the creation, management, and optimization of manufacturing and quality system documentation. Candidates should be capable of operating with minimal supervision and adhering to established company policies, procedures, and regulatory standards specific to the biotechnology sector.

Key Responsibilities:

• Change Control:
• Collaborate with Quality Assurance and other relevant departments to manage document modifications essential for biotech projects, including new biotech products, biotechnological equipment, and components.
• Ensure all documentation meets the rigorous standards for accuracy, clarity, and compliance with both internal policies and external biotech regulatory requirements.
• Oversee the cross-functional review and approval of documentation changes, facilitating discussions to resolve issues and guarantee comprehensive participation and quality review.
• Analyze changes to the Bill of Materials (BOMs) and integrate these changes into electronic data management systems like Master Control or ERP systems.
• Enhance and streamline the change control process, proposing and implementing improvements.
• File Maintenance and Auditing:
• Manage the archiving of quality records including manufacturing Device History Records (DHRs), Change Packets, Design History Files, Validations, Complaints, and Receivers.
• Audit documents and change control files and maintain corresponding electronic logs and databases, ensuring compliance with GMPs, Federal Regulations, ISO standards, and company procedures.
• Address and follow up on Corrective/Preventive Action Requests as they relate to document control.
• Training and Compliance:
• Develop and provide targeted training sessions on document control systems and processes specific to biotech applications.
• Create and maintain metrics to monitor and report on the effectiveness of the document control processes.
• General Administration:
• Generate and present status and operational reports for management reviews.
• Represent the document control department in internal and external audits, and participate in departmental and company-wide meetings.
• Undertake additional duties as needed, in accordance with business policies and regulatory requirements.

Interactions:

• Work closely with QA Documentation for effective planning and scheduling, ensuring alignment with departmental and corporate objectives.
• Provide essential support to other departments requiring assistance with documentation processes, ensuring smooth and compliant operations across the company.

Work Environment:

• Office-based with a combination of sitting, standing, and walking to perform job functions.
• Flexible work hours to meet project deadlines, with occasional travel required.

Physical Demands:

• Ability to occasionally lift up to 30 pounds.
• Frequent use of computer and other office equipment.

Requirements:

• Education: High school diploma required; Bachelor’s degree in a relevant field such as Business Administration or Management Science preferred.
• Experience: 1 to 8 years of experience in documentation control within a biotech or similar regulated environment.
• Skills: Advanced command of English with excellent writing, grammar, and proofreading skills; proficient in Microsoft Office and experienced with Electronic Data Management Systems.
• Attributes: Highly detail-oriented, self-motivated, and capable of leading documentation control activities with minimal supervision.

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