Catalent · 11 hours ago
Quality Documentation Specialist
Manassas, VA
Full-time
Onsite
Entry Level
2+ years expCatalent is a global leader in drug development and delivery, specializing in consumer health products. The Quality Documentation Specialist will be responsible for the creation and maintenance of Quality System documentation, ensuring compliance with regulatory standards and assisting 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
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.
10001+ employees
H1B Sponsorship
Catalent has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2021-01-06Acquired
Leadership Team
Alessandro Maselli
President & Chief Executive Officer
Charles Lickfold
Senior Vice President, Chief Information Officer
Recent News
2026-01-22
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