Document Control Specialist III (1128-679)
This is a hands-on, non-supervisory position that supports the important work of USP’s Quality Assurance Document Control team. The incumbent’s primary responsibility is to manage company documents while also ensuring their accuracy, quality and integrity. They are also responsible for adhering to USP’s record retention policies and the need to safeguard information and retrieve data effectively. They will also assist in reviewing, editing and formatting, SOPs and other technical / scientific documents. The incumbent anticipates and solves problems and issues within his/her area of responsibility. In addition, the incumbent independently leads, designs, develops and implements new tools and techniques used in the Document Management system.
Roles and Responsibilities
- Independently lead and coordinate the operation, maintenance and improvement of the document control system
- Review, edit and format documents and initiate/manage document workflows
- Assign effective date of approved documents and send training notification
- Store, manage and track company documents
- Scan, image, organize and maintain documents, adhering to the company's document lifecycle procedures
- Archive inactive records in accordance with the records retention schedule
- Coordinate the triennial/annual review of documents
- Interact with International locations as needed to coordinate document review and revision.
- Collaborate with USP staff as needed during the document revision process
- Track progress of documentation tasks, ensuring accurate and timely delivery of all projects
- Track and trend data and prepare monthly quality metric reports
- Independently lead the design, development, implementation and operation of an electronic document control/management system
- Independently identify and lead Process Improvement initiatives
- Provide training on Document Control concepts and tools, and design/develop training and instructional materials
- Performs other related duties as required
- Model USP values in all aspects of work performance and interaction.
- Associate’s degree required or equivalent combination of education and experience
- At least 7 years of document control experience in a pharmaceutical, biotech, or other regulated industry
- Strong computer skills, advanced experience with Microsoft Office Suite required (Word, Access, Excel and Visio)
- Experience with electronic document control software required
- Familiarity with document databases and repositories required
- Bachelor’s degree preferred
- Good understanding of ISO 9001, ISO 17025 and some understanding of cGMPs
- Working knowledge of Adobe Acrobat
- Highly motivated, self-directed and the ability to work independently
- Ability to stay focused and to carry out tasks in a timely and accurate manner
- Ability to prioritize, manage time well, multitask and troubleshoot
- Strong interpersonal, communication and customer service skills are essential because document control specialists regularly communicate with internal and external business partners
- Ability to work as a team member, maintaining day to day activities while being responsive to changing priorities
- Ability to communicate and interface with customers, third parties and diverse audiences at all levels of the organization
- Must have demonstrated initiative and ability to work independently while handling multiple tasks
- Demonstrated decision making skills
- Demonstrated hands-on experience in designing and or implementing a document management system
- Demonstrated leadership potential and ability to lead teams and cross functional projects
- Demonstrated verbal and written communication skills
- Excellent writing, proof reading and presentation skills
- Demonstrated presentation/ facilitation skills
USP offers an impressive benefits package, including:
- Generous paid time off – 13 paid holidays, 10 sick days and 15 vacation days per year to start
- An annual 401(k) contribution, beginning after 1 year of service, of 10% of pay (base and bonus) every pay period that vests immediately
- Comprehensive individual and family healthcare plans with affordable premiums and low annual deductibles ($250/individual or $500/family)
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
Being a part of USP means belonging to a diverse culture made up of more than 1,000 talented professionals working together at five international locations. We share our expertise in science, IT, human resources, quality assurance, communications, administrative management, and more...all to support an overall mission dedicated to making a difference by providing standards and programs that help improve the quality of medicines, dietary supplements, and foods worldwide.
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.Required Experience Job Location Rockville, Maryland, United States Position Type Full-Time/Regular