Senior Document Controller

Aurora Lifesciences; South Yorkshire; On-site; GBP 50,000 - 70,000; Full time

Job summary

Aurora Lifesciences is seeking an experienced Senior Document Controller to manage controlled documentation and quality records within a regulated manufacturing environment. You will support document lifecycle management, change control, audit readiness and compliance with ISO13485 and applicable regulatory requirements.

The role will work closely with Quality, Regulatory, Manufacturing and Engineering teams to ensure documents are accurate, approved, traceable and available when required.

Qualifications

• At least seven years’ experience in Quality, Quality Systems or document control within medical devices, pharmaceuticals or another regulated industry.
• Practical experience with ISO13485 Quality Management System.
• Knowledge of 21 CFR Part 820 or equivalent regulated quality requirements.
• Strong experience managing controlled documents, quality records and change control workflows.
• Experience supporting audits or regulatory inspections.
• Experience reviewing manufacturing records, batch records or product release documentation.
• Experience training or supervising junior colleagues is desirable.
• Experience using an eQMS, document management system or PLM platform is highly desirable.

Responsibilities

• Process document, item and engineering change requests in line with approved change control procedures.
• Review change orders for accuracy, completeness and appropriate approvals.
• Manage the creation, review, approval, issue, revision, withdrawal and archiving of controlled documents.
• Ensure quality records are filed and retained in accordance with ISO13485 and internal procedures.
• Assign document numbers, revision levels and controlled identifiers.
• Maintain document registers, training matrices and associated training records.
• Ensure current document versions are available at the point of use.
• Monitor outstanding document reviews, approvals and change control activities.
• Retrieve records for internal audits, external audits and regulatory inspections.
• Train employees on document control, ISO13485 and change control requirements.
• Support and supervise junior documentation team members.
• Identify opportunities to improve document control processes and electronic systems.
• Releasing work-in-progress and final packaging labels.
• Reviewing manufacturing, production and product-handling records.
• Checking records for completeness, accuracy, traceability and Good Documentation Practice compliance.
• Reviewing batch records, device history records or equivalent product documentation.
• Working with document originators to correct errors before approval or product release.
• Ensuring changes to labels, specifications and manufacturing records follow the approved change control process.

Job description

About the Role

Aurora Lifesciences client an innovative medicaltechnology organisation that is looking for an experienced Senior Document Controller to manage controlled documentation and quality records within a regulated manufacturing environment.The Senior Document Controller will support document lifecycle management, change control, audit readiness and compliance with ISO13485 and applicable regulatory requirements. The role will work closely with Quality, Regulatory, Manufacturing and Engineering teams to ensure documents are accurate, approved, traceable and available when required.

Key Responsibilities

• Process document, item and engineering change requests in line with approved change control procedures.
• Review change orders for accuracy, completeness and appropriate approvals.
• Manage the creation, review, approval, issue, revision, withdrawal and archiving of controlled documents.
• Ensure quality records are filed and retained in accordance with ISO13485 and internal procedures.
• Assign document numbers, revision levels and controlled identifiers.
• Maintain document registers, training matrices and associated training records.
• Ensure current document versions are available at the point of use.
• Monitor outstanding document reviews, approvals and change control activities.
• Retrieve records for internal audits, external audits and regulatory inspections.
• Train employees on document control, ISO13485 and change control requirements.
• Support and supervise junior documentation team members.
• Identify opportunities to improve document control processes and electronic systems.

Product Release and Manufacturing Support

The Senior Document Controller will also support operational quality activities, including:

• Releasing work-in-progress and final packaging labels.
• Reviewing manufacturing, production and product-handling records.
• Checking records for completeness, accuracy, traceability and Good Documentation Practice compliance.
• Reviewing batch records, device history records or equivalent product documentation.
• Working with document originators to correct errors before approval or product release.
• Ensuring changes to labels, specifications and manufacturing records follow the approved change control process.

Experience Required

• At least seven years’ experience in Quality, Quality Systems or document control within medical devices, pharmaceuticals or another regulated industry.
• Practical experience working within an ISO13485 Quality Management System.
• Knowledge of 21 CFR Part 820 or equivalent regulated quality requirements.
• Strong experience managing controlled documents, quality records and change control workflows.
• Experience supporting audits or regulatory inspections.
• Experience reviewing manufacturing records, batch records or product release documentation.
• Experience training or supervising junior colleagues is desirable.
• Experience using an eQMS, document management system or PLM platform is highly desirable.

Skills and Capabilities

The successful Document Controller will have:Excellent attention to detail and organisational skills.Strong knowledge of ISO13485 document and record control requirements.Practical understanding of change control and document change orders.The ability to read manufacturing drawings, specifications and technical documents.Familiarity with bills of materials and item-related documentation.Strong written and verbal communication skills.Confidence challenging incomplete or inaccurate documentation.The ability to manage multiple priorities in a regulated environment.A proactive and hands-on approach