Document Control Specialist
Fullscript’s purpose — helping people get better — is core to everything we do. We’ve created a virtual dispensing solution that supports practitioners as they support millions of patients across North America with the industry’s best supplements. That said, our purpose extends well beyond our platform. Helping people get better is at the core of our business decisions and how we treat our #fullscriptfam.
By joining us, you stand with our purpose. You are an independent thinker, who likes to leave things better than you found them. You do things not because they are easy but because they are right. Ready to make an impact?
As the Document Control Specialist you will have a strong commitment to data integrity, compliance, and quality in their responsibilities related to: validating supplier product data and content; review of practitioner, patient, and consumer educational content and information; and support in the company’s regulatory compliance. Responsibilities include current and future brand partner content (to include descriptions, images, and video), guidance for educational content to support Healthcare Practitioner and patient knowledge base, and quality assurance related supplier product data and data structure initiatives. Additionally duties include supporting regulatory compliance and certification processes.
What you’ll do:
- Support the Core Values of Fullscript
- Support the Quality Assurance and Regulatory Affairs team as well as other functional groups in the following areas:
- Maintain oversight for the use and maintenance of the company document control processes.
- Developing documents (standard operating procedures, forms, product labeling, specification and sheets) to ensure regulatory compliance. Establish/maintain procedures for inspection readiness, good documentation practices, and change control.
- Ensure documents follow the standard format and review quality records to minimize typographical errors and other types of documentation errors.
- Assist to develop and maintain documents and other required records for state level prescription programs.
- Verify that all items requiring revision control have been correctly entered into the document control process, and that they are properly linked to ensure full traceability.
- Ensure documents and records meet quality standards prior to the submission for final review and signatures.
- Coordinates the revision, review, approval and decommissioning of company SOPs (Standard Operating Procedures), workflows and other cGMP (current Good Manufacturing Practice) documents.
- Organizes and ensures accurate and reliable filing systems for all hard-copy and electronic GMP (Good Manufacturing Practice) documents. Maintain onsite and electronic documentation storage as applicable.
- Create reports and assist in closing actions out in a timely manner.
- Process requests for information, retrieve files and other records as required and lead the efforts to keep the document control system in compliance.
- Oversee State level regulatory registrations filings and registered agent services.
- Performs other tasks as required.
What you bring to the table:
- Ability to read, write, and orally communicate at a high level in correlation at a professional level to solicit/explain information.
- Prior experience within the Dietary Supplement industry is a plus.
- Working familiarity in the use of software applications such as: Google Suite, Excel, Word PowerPoint and Adobe Acrobat.
- Must be well-organized and proficient at reviewing and editing documentation.
- High attention to detail and ability to solve problems and communicate issues; ability to work on multiple projects (multitask) simultaneously.
- Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet deadlines.
- Ability to work independently with minimal supervision and to work on a team.
- Knowledgeable technical writing is a plus.
- Bachelor degree preferred.
Our team handles a lot of sensitive health information, which means we require all candidates that receive and accept employment offers to complete a background check before being hired.
What we can offer you:
- Generous PTO and competitive pay
- Fullscript’s 401k program for financial health
- Flexible benefits package (medical, dental, vision) and workplace wellness program
- Training budget and company-wide learning initiatives
- Discount on Fullscript catalog of products
- Ability to work Wherever You Work Well*
*Our Wherever You Work Well philosophy means Fullscript teammates get to pick their own office — whether that’s in-office, at home, or a bit of both. We also believe pups make life better, which also means some of our physical locations are dog-friendly. 🐶
Fullscript is committed to diversity in its workforce and is proud to be an equal opportunity employer. We are excited to work with talented people, period. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion or belief, national or ethnic origin, gender, age, disability, sexual orientation, gender identity and/or expression, marital or civil status, political affiliation, family or parental status, or any other status protected by the laws or regulations in the jurisdictions in which we operate. Accommodations are available on request for candidates taking part in all aspects of the selection process. Please send an email to email@example.com and let us know the nature of your request and your contact information.
Want to learn more? Check us out at www.fullscript.com or find us on social media.