Documentation Administrator

Location
Rockville, MD
Posted
Jul 01, 2022
Ref
DOCUM001691
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time

Summary of the Position

This position is responsible for providing document management support for physical reference materials including but not limited to USP Reference Standards (RS), Pharmaceutical Analytical Impurities (PAI), Certified Reference Materials (CRM), and FCC Analytical Materials (FAM). The incumbent will be responsible for working within the pre-defined operational aspects of the program to manage the timely approval, distribution, and archiving of product specific documents. The incumbent will work closely with RSE, RMA, Exec Sec, RSP and QA teams, along with the product management function within USP.

Roles and Responsibilities

• Provides document management for USP’s physical materials programs, following appropriate prioritization for the approval of RSCEP’s, RSCF’s, PAIR’s and other related documents.

• Creates and deploys accurate document signature routings. 

• Maintains Excel database to record and track development status of product documents (RSCEPs, PAIRs, etc.). 

• Prompts stakeholder action as needed to ensure timely document delivery.

• Participates in purchase requisition approval process in Oracle EBS for physical materials. 

• Provides department-controlled document support and management for RMS and other GLTO groups as needed. 

• Maintains relationships with global Business Operations team, working closely to achieve on-time delivery of products and works to resolve logistical and other operational bottlenecks. 

• Facilitates group interactions through both interpersonal and tool-based communications.

• Collaborates with management and coworkers to develop, improve, and standardize document-related processes.

• Supports cross-departmental and cross-divisional activities related to streamlining product development and release.

Basic Qualifications

• Bachelors degree

• One year of experience in a role that involve aspects of document management,

• Equivalent work/education experience considered

Skills Sought

• Ability to develop strong working relationships at all levels.

• Good communication skills with the ability to get results without authority across departments

• Excellent work-ethic and a drive for professional growth

• Demonstrated MS Office (Word, Excel) skills 

Preferred Qualifications

• Understanding of USP processes and various functions within the organization 

• Working knowledge of the pharmaceutical industry, with basic knowledge of drug substance, drug product, NDA and ANDA, reference standards and pharmacopoeias

• Experience with creating reports for management utilizing MS Excel skills 

• Experience in Oracle ERP.

• Bachelor’s degree or comparable, relevant work experience 

• Experience working with DocuSign or other document signature platform

• Demonstrated ability to get results without authority. 

Supervisory Responsibilities

N/A

Benefits

USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing are protected.

About USP

The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements 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. 

COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired:

As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully present vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.