Senior Document Control Specialist II

How you’ll make an impact:

As a Senior Document Control Specialist II, you will make an impact by advising and assisting 2seventy employees with Veeva Vault workflows and any document control needs that help contribute to the overall success of the company!

About the team:

The Quality Assurance department is all about working collaboratively with our stakeholders to promote our Quality Culture and do things right. Whether it’s making sure documents are up to date, quality records are managed compliantly, or QMS data is compiled, we are driven by providing the highest quality products to our patients. Come work with a energized group of employees that loves rising to the challenge much as we do to support our patients and the 2seventy organization!

How you’ll spend your time:

• 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+ years of document control experience supporting GMP documentation programs and systems in pharmaceutical or biopharmaceutical industries
• Technical writing experience a plus
• 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