Document Coordinator

BioSpace; Swiftwater (Monroe County); On-site; USD 60,000 - 75,000; Full time

Job summary

Sanofi, a global biopharma company, seeks a Document Coordinator to support QC data review, GDP-compliant documentation, and the lifecycle of QC documentation. You will collaborate with SMEs to maintain SOPs and ensure tests and records meet cGMP standards.

The role emphasizes data integrity, regulatory readiness, and cross-functional teamwork across quality systems. This position is based in Swiftwater, PA and involves on-site activities in Manufacturing & Supply.

Qualifications

• Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or related field.
• 3–5 years of experience in QC laboratory operations, pharma environment preferred.
• Strong understanding of GxP requirements and pharmaceutical quality systems.
• Experience with analytical testing methods and equipment.
• Proficiency in document management systems (e.g., QualiPSO, electronic document management systems).
• Knowledge of test data review processes and data integrity principles.
• Experience coordinating documentation workflows and managing stakeholder reviews.

Responsibilities

• Test Data Review: ensure trained/qualified for analytical testing and review data.
• QC data review of executed tests to meet schedules.
• Inform manager of quality or HSE deviations and assist investigations.
• Support root cause analysis investigations for testing deviations.
• Coordinate QA documentation lifecycle activities and approvals.
• Ensure GDP-compliant documentation and update QC SOPs.
• Manage document revision schedules and SME content development.
• Coordinate stakeholder reviews and consolidate feedback.
• Train lab personnel on new or revised procedures.
• Review test data for accuracy, completeness, and compliance.

Skills

GxP knowledge

Analytical testing methods

Document management systems

Quality systems

Attention to detail

Verbal communication

iShift navigation

Education

Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or related field

Tools

QualiPSO

Job description

Job title: Document Coordinator

Location: Swiftwater, PA

About The Job

Join a global network that powers how Sanofi delivers seamlessly, purposefully, and at scale. In Manufacturing & Supply, youll help reimagine how life-changing treatments reach people everywhere, faster.

About Sanofi

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

Main Responsibilities

• Test Data Review: Ensuring that he/she is trained and qualified to the assigned analytical testing that requires to be qualified
• Performing the QC data review of executed tests by other analysts in a timely manner, ensuring adherence to the committed scheduled plans
• Informing his/her manager of any quality or HSE event (deviations, OOx,) in a timely manner to ensure investigation and impact assessment are performed appropriately Participating actively to any investigation, where he/she is involved, to ensure investigations and impact assessment are performed appropriately
• Support root cause analysis investigations for testing deviations

Document Coordination

• Coordinate quality control documentation lifecycle activities
• Manage document workflows, including review, approval, and distribution processes
• Ensure documentation compliance with good documentation practices (GDP)
• Create, maintain, and update QC technical documentation and SOPs
• Monitor document revision schedules and coordinate periodic reviews
• Liaise with subject matter experts (SMEs) for document content development
• Support metadata management and document control activities in quality systems (e.g., QualiPSO)
• Coordinate stakeholder reviews and consolidate feedback

Other Accountabilities

• Executing assigned CAPAs related to remediation plans, continuous improvements
• Ensuring that his/her lab/facilities, lab instruments are kept in a quality and safety status to ensure that they can be used appropriately.
• Executing analytical testing in a timely manner, ensuring adherence to the committed scheduled plans
• Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records, related to these tasks
• Recording all expected raw data, calculations, information, related to his/her tasks, to comply with cGMP and data integrity requirements
• Supporting laboratory and deviation investigations

Typical Activities

• Review test data for accuracy, completeness, and compliance
• Coordinate the creation, review, and approval of QC SOPs and technical documents
• Manage document change requests and assess impact on testing operations
• Facilitate document review meetings with cross-functional teams
• Maintain document control records and ensure proper version management
• Support regulatory inspections by providing documentation and technical expertise
• Participate in CAPA investigations related to testing or documentation issues
• Monitor documentation metrics and report on completion status
• Train laboratory personnel on new or revised procedures

About You

Key Qualifications

• Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or related field
• 3-5 years of experience in QC laboratory operations. Working in a pharmaceutical environment is preferred.
• Strong understanding of GxP requirements and/or pharmaceutical quality systems
• Experience with analytical testing methods and equipment
• Proficiency in document management systems (e.g., QualiPSO, 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
• Knowledge of iShift functionality and navigation is preferred

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave.
• Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.