QA Document Control Specialist

How you’ll make an impact:

You will be working cross-functionally to provide document support within 2seventy bio. You will work in collaboration with the QA Training group and the rest of the Quality Organization to ensure timely completion of training assignments.

About the team:

The QA Document Control team is all about efficiency, excellent customer support, and compliant thinking. Whether it's making sure we are successful during inspections, supporting our peers, or helping deliver on our Quality objectives, you will feel a sense of satisfaction every day. Come work with an incredible group that excels at rising to challenges and brings a unique sense of fun and camaraderie to our daily tasks! 

How you’ll spend your time:

As a Senior Associate reporting to a Senior Manager of Document Control and Training, you will:

• Support the maintenance of the document control system, including formatting, numbering, record retention and change control
• Review new and revised controlled documentation for appropriate format, content and consistency with other documentation and compliance to document control procedures
• Support improvement initiatives to strengthen document management processes and systems
• Assist in development and use of document templates, standards and conventions
• Support customers in development and use of document standards
• Track documents during the routing, review and approval process
• Maintain filing and archiving of paper records
• Issue and manage electronic records in the EDMS
• Assist with the archival & retrieval of records to off-site document storage facility(ies)
• Provide support for all documentation control activities
• Provide support during audits of regulatory agencies
• Other duties as assigned

Who you are and what you’ve accomplished:

•  BS/BA with 3-5 years of document control experience supporting GMP documentation programs and systems in pharmaceutical or biopharmaceutical industries
• Technical writing experience a plus
• Veeva QualityDocs experience preferred
• Firm understanding of FDA and global requirements related to cGMP documentation
• Strong oral and written communication skills
• Excellent interpersonal, teamwork, and organizational skills
• Must be capable of multi-tasking and performing assignments that have loosely defined objectives with minimal supervision
• Expert Proficiency with Microsoft products and document publishing software (e.g. Excel and Adobe Pro); must be able to learn additional applications as needed
• Must be able to work in a fast-paced environment and function under pressure
• Must have excellent attention to detail and time management skills as well as the ability to manage multiple priorities with aggressive timelines and changing priorities