Documentation Specialist

We are seeking a detail-oriented professional for a Quality Systems Documentation Management contract position. This onsite role is critical for maintaining compliance and site inspection readiness through the rigorous management of physical and electronic documentation. Working closely with system owners and the broader team, you will ensure total alignment with Good Documentation Practices (GDP) and global and site-specific quality procedures.

Responsibilities

• Manage document issuance and reconciliation tasks using Veeva, an electronic document management system.
• Provide archiving assistance for paper records in the High Density Storage Room (HDSR).
• Partner with system owners to actively maintain the site in an inspection-ready state.
• Update the Record Inventory Management System (PRIMS) for archived paper documents, including archiving files and fulfilling document check-out requests.
• Assist the team with organizing paper batch records extracted from SAP to prepare them for issuance.
• Maintain strict adherence to Good Documentation Practices (GDP) when performing data entry into quality systems.
• Guide and advise others on proper Quality System procedures and processes to ensure all internal documentation requests are submitted appropriately.

Education

• A Bachelor's degree is preferred.
• An Associate's Degree (AA) or a High School Diploma will be accepted if accompanied by at least two years of related GMP Biopharma experience.

Experience

• Prior experience working within a Good Manufacturing Practice (GMP) environment.
• Hands-on knowledge or familiarity with an electronic document management system, specifically Veeva.
• Practical knowledge of a quality system used for documentation, as well as archiving or organizing physical paperwork.
• Strong computer skills with a focus on data entry proficiency.