Job Description

JOB TITLE SPECIALIST I, QUALITY ASSURANCE – QUALITY OPERATIONS

Department Quality Assurance – Quality Operations

Reports To Supervisor, Quality Assurance – Quality Operations or above

Ladder Level 2

DESCRIPTION

Position Overview

The Specialist I, Quality Assurance performs routine activities associated with manufacturing of cell and

gene therapy products at the Abeona Therapeutics Inc. site in Cleveland, OH. This position is

responsible for document review which includes, but is not limited to: editing, formatting, and

proofreading prior to SME approval in the Quality Management System. This position is also

responsible for document archival and retention post product disposition. The Specialist I, Quality

Assurance will report to the Supervisor, Quality Assurance or above and will support all document

review and retention/archiving for the site.

 

Essential Duties and Responsibilities

Position is Day Shift with weekends (only as needed).

• Performs the following duties with minimal supervision.
• Manage the process for the creation, review, editing, and formatting of all GxP controlled documents prior to approval in the Quality Management System per Abeona Style Guide and/or applicable templates. Documents include but are not limited to, master production records, Quality Control test methods, forms, standard operating procedures, protocols and reports, etc.
• Manage electronic document management system (DMS) document lifecycle workflows and assignment of reviewers / approvers and training tasks.
• Format and proofread new documents to ensure compliance with approved templates, procedures and DMS requirements.
• Provide guidance to document initiators, owners, and users to ensure compliance with all applicable procedures / regulations, formats, and assist users with DMS workflow related issues.
• Control document lifecycle activities, including biennial review of procedures and document retention for select SOPs.
• Compile, organize, and label all batch-related documents into a final product lot disposition package.
• Organize, scan, label, catalog, and file all documents needing to be archived. Document types include but are not limited to, batch production records, studies, logbooks, laboratory notebooks, raw data, etc.
• Manage Document Storage Room for the Cleveland site.
• Manage storage of documents at off-site archive location(s) as needed.
• Maintain and ensure document retention periods in accordance with regulatory requirements.
• Support site inspections, as needed.
• Perform other duties as required.

Qualifications

• Minimum of a Bachelor’s degree in related field and/or equivalent experience.
• Minimum of 1-3 year of experience in quality and/or manufacturing in a pharmaceutical, biotech, or biologics cGMP regulated manufacturing environment preferred.
• Working knowledge of quality operations and ability to apply cGMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards.
• Basic knowledge of aseptic manufacturing processes.

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