Document Coordinator

Sanofi • Pocono Township, PA

4d • $27 - $36 • Onsite

About The Position

The Document Coordinator supports quality control operations by reviewing test data and coordinating the lifecycle of quality control documentation. The role reviews executed tests for accuracy, completeness, and compliance; helps ensure work follows cGMP, HSE, data integrity, and applicable quality requirements; and supports investigations and corrective actions. It also coordinates document workflows and stakeholder reviews, maintains controlled records and current versions, and supports inspections and laboratory personnel training.

Requirements

• Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related field.
• 3–5 years of experience in QC laboratory operations.
• Strong understanding of GxP requirements and/or pharmaceutical quality systems.
• Experience with analytical testing methods and equipment.
• Proficiency in document management systems, such as QualiPSO or electronic document management systems.
• Knowledge of test data review processes and data integrity principles.
• Experience coordinating documentation workflows and managing stakeholder reviews.
• Excellent attention to detail and organizational skills.
• Strong written and verbal communication skills.

Nice To Haves

• Experience working in a pharmaceutical environment is preferred.
• Knowledge of iShift functionality and navigation is preferred.

Responsibilities

• Ensure qualification and training for assigned analytical testing when required.
• Review QC data from tests performed by other analysts promptly and in line with scheduled plans.
• Report quality or HSE events to the manager in a timely manner and participate in relevant investigations and impact assessments.
• Support root cause analysis for testing deviations and support laboratory and deviation investigations.
• Coordinate quality control documentation lifecycle activities, including review, approval, and distribution workflows.
• Ensure documentation complies with good documentation practices (GDP).
• Create, maintain, and update QC technical documentation and SOPs; monitor revision schedules and coordinate periodic reviews.
• Liaise with subject matter experts to develop document content, coordinate stakeholder reviews, and consolidate feedback.
• Support metadata management and document control activities in quality systems such as QualiPSO.
• Execute assigned CAPAs related to remediation plans and continuous improvements.
• Maintain laboratory facilities and instruments in an appropriate quality and safety status.
• Perform assigned analytical testing in a timely manner and according to scheduled plans.
• Perform tasks in accordance with cGMP, HSE requirements, and applicable instructions, procedures, and records.
• Record required raw data, calculations, and related information in compliance with cGMP and data integrity requirements.
• Coordinate creation, review, and approval of QC SOPs and technical documents; manage document change requests and assess impacts on testing operations.
• Facilitate cross-functional document review meetings and maintain document control records and version management.
• Support regulatory inspections by providing documentation and technical expertise.
• Monitor documentation metrics and report completion status.
• Train laboratory personnel on new or revised procedures.

Benefits

• Health and wellbeing benefits, including high-quality healthcare and prevention and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Employee benefit programs may be available to eligible employees.
• Rewards package recognizing employee contributions.
• Opportunities for career growth through promotion or lateral moves, at home or internationally.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level