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Catalent · 13 hours ago

Document Control Specialist

Manassas, VA

Full-time

Onsite

Entry Level

2+ years exp

Catalent, Inc. is a leading global contract development and manufacturing organization dedicated to improving health through innovative products. The Document Control Specialist is responsible for the creation and maintenance of Quality System documentation, ensuring compliance with internal and regulatory standards, and supporting the Quality Assurance team with various projects.

BiotechnologyHealth CareManufacturingPharmaceutical

Responsibilities

Create, revise, and maintain all documentation related to the Quality System using technical writing best practices, ensuring proper formatting, numbering, and document control

Issue batch records to Production and Packaging departments in a timely and accurate manner

Review and sign off on completed batch production records to verify compliance with internal and regulatory requirements

Support third-party certifications and customer audits by preparing documentation and assisting on-site as needed

Manage the routing, review, and approval processes for controlled documents, deviations, change controls, and other QMS-related records

Perform internal audits to assess compliance with Quality System standards; document and report all findings and non-conformances

Collaborate in cross-functional meetings during New Product Introductions (NPIs) and Change Control processes

Track and document all areas of non-compliance and assist in the implementation and verification of corrective and preventive actions (CAPAs)

Work closely with Production, Packaging, R&D, and other departments to maintain and update records, specifications, and process documents

Other duties as assigned

Qualification

Quality System documentationHACCPGMP knowledgeExcel proficiencyTechnical writingSpanish languageCollaboration skillsAttention to detail

Required

HS Diploma or GED required

2+ years of experience working with documentation or quality systems required

Ability to read and follow documents (Standard Operating Procedures and Test Methods)

Knowledge of GMP and Quality systems

Previous experience in Excel and Microsoft Office

The employee must be able to lift and/or move up to 50 pounds

While performing the duties of this job, the employee is required to use hands to finger, handle, or feel and is frequently required to stand, walk, reach with hands and arms, stoop, kneel, crouch, or crawl, and talk or hear

The employee is required to sit, climb or balance and taste or smell

Preferred

Bachelor's degree in Food Science, Engineering, or technical major is preferred

PCQI or HACCP experience is preferred

Knowledge of spoken Spanish is a plus

Benefits

152 hours of PTO + 8 paid holidays

Company

Catalent

Catalent - Blow-Fill-Seal Sterile CDMO Business is focusing on complex clinical to commercial stage formulation and manufacturing. It is a sub-organization of Catalent Pharma Solutions.

Founded in 2007

Somerset, New Jersey, USA

10001+ employees