Vaccinex is a clinical-stage biotechnology company engaged in the discovery and development of targeted biotherapeutics to treat serious diseases with unmet medical needs, including neurodegenerative diseases, cancer and autoimmune disorders. We believe we are the leader in the field of semaphorin 4D (SEMA4D) biology, and that we are the only company evaluating SEMA4D blockade as a potential treatment for neurodegenerative diseases, cancer or autoimmune disorders. Vaccinex has also developed a proprietary antibody discovery platform, ActivMab®, that enables efficient mammalian cell-based expression of a library of human antibodies using viral vectors. In addition, this fusion protein technology enables the direct incorporation of conformation-dependent multipass membrane proteins, such as GPCRs and ion channels, into the viral membrane.
The Quality Systems Associate is responsible for executing tasks related to maintaining and managing electronic documents and records in a part 11 compliant database to achieve compliance with cGMP, GLP, and GCP requirements at Vaccinex.
- Maintain an electronic documentation management system (EDMS) compliant with FDA regulations and expectations.
- Assist in updates of EDMS database as required.
- Manage SOPs for the use of the Policies & Procedures and Records & Reports quality systems.
- Manage the preparation, routing, review, approval, distribution, and archival of new and revised controlled documents.
- Conduct periodic review of SOPs and other controlled documents to ensure they are current.
- Train personnel in the use of the EDMS and assist in the generation of SOPs by Vaccinex GXP personnel.
- Ensure the timely review and approval of controlled documents by tracking and coordinating the review process in a proactive fashion
- Collaborates with cross-functional departments to ensure timely implementation of document change requests.
- Manage a controlled access to the archive of all records compliant with cGMP, GLP, and GCP regulations and expectations building on the existing Vaccinex retention program; coordinate the record submission and maintenance of the Trial Master File for each clinical program.
- Maintain GXP training programs and associated training records.
- Generate quality metrics related to document and record management on a periodic basis.
- Perform other duties as required.
- BS/BA degree in biological or physical sciences, or equivalent combination of education and experience, is required.
- At least 2 years in the regulated bio/pharmaceutical industry with previous experience with document and record management is preferred.
- Scientific technical background with an emphasis on skills and know-how related to the manufacture, laboratory testing, and release of therapeutic biologic products (e.g., therapeutic monoclonal antibodies, vaccines) in the biopharmaceutical industry is strongly preferred.
- Excellent attention to detail is a must have.
- Strong interpersonal and team skills; ability to manage multiple initiatives and projects simultaneously is required.
- Excellent written and oral communication skills; ability to work independently and as a team member; demonstrated strong leadership skills is required.
- Must be competent in computer programs such as Microsoft Word, Microsoft Excel, Microsoft PowerPoint; experience with EDMS software is preferred.
Please Note: Due to the high volume of responses, only inquiries from qualified candidates can be addressed.
No telephone inquiries or recruiters, please.
Vaccinex, Inc. is an equal opportunity employer.
Please send resume via e-mail to email@example.com.