Job Information
The U.S. Pharmacopeial Convention (USP) Document Control Specialist in Hyderabad, India
Description
Who is 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's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,100 talented professionals across five global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.
Brief Job Overview
This is a hands-on, non-supervisory position that supports the important work of USP’s Quality Assurance Document Management team. The Document Control Specialist is the expert in management of all quality documentation and training with respect to business objectives, provides guidance regarding Document workflow, proof-reading, and accuracy of documents. All Document Control functions must be compliant with applicable ISO Requirements and industry best practices. This position is responsible for organizing, maintaining, and updating all controlled documents and ensuring training is executed in a timely manner. The Document Control Specialist trains all levels of users in electronic document management system (EDMS) functions and collaborates with all departments to maintain a compliant document management system and meet business needs. This position works independently, with minimal supervision, to accomplish daily tasks by efficiently and effectively utilizing the Company’s EDMS. The Document Control Specialist will drive continuous improvement within the system and create and maintain metrics regarding document status, priority, change management, and training completion.
How will YOU create impact here at USP?
The Document Control Specialist is the EDMS SME, responsible for managing all aspects of the document management processes, as well as training.
Review, edit and format documents, approves document change requests, release approved documents and manages document workflows, including new document, document revision and document obsoletion.
Manages EDMS users including activating and deactivating users, assigning appropriate roles per business needs, maintaining/assigning job codes, creation of new hire training infocard and assigning new hire mandatory trainings.
Creation of training courses, sessions, and support trainers on updating of class roll.
Serves as the MasterControl System Administrator SME and provides training/guidance to all levels of system end-users regarding processes of document management and training, and EDMS. Resolve issues during trouble-shooting requests.
Designs/develops/maintains training courses, instructional materials, and training records for the various levels of system users.
Improves and streamlines processes of document management, training, and user management.
Develops/maintains/reports metrics periodically regarding document management and training. Identifies negative data trends and escalates immediately as necessary.
Tracks/follows up key activities, e.g., miss assigned document review, overdue triennial review, pending/ overdue training tasks, etc.
Prioritizes activities by compliance and business requirements
Communicates effectively with cross-functional and external stakeholders
Coordinate with USP Global Site SME’s and MasterControl Customer Support Team to resolve any application issues/glitches for a quick resolution.
Manages/Supports QA department record retention schedules
Assumes other responsibilities as assigned by functional manager
Who USP is Looking For?
The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:
Masters/Bachelor’s degree in science (chemistry/pharmacy) or computers required or equivalent combination of education and experience.
At least 3 years of document control experience in a pharmaceutical, biotech, or other regulated industry
Strong computer knowledge (MS Office)
Demonstrated initiative and ability to work independently while handling multiple tasks, as well as part of a team in a dynamic environment.
Must have strong technical writing and proofreading skills, as well as exemplary attention to detail due to demand for accuracy in controlled documents.
Ability to clearly communicate, both verbal and written and interface with customers and third parties, and diverse audiences at all levels of the organization.
Strong focus on internal and external customer service
Additional Desired Preferences
EDMS experience as Administrator
Good understanding of QMS Systems and ISO Standards.
Excellent written and verbal communication skills including well-developed interpersonal skills used to influence the behavior of others.
Any diploma in computers or relevant QMS certifications on document management systems and good documentation practices is an added advantage.
Outstanding organizational skills and ability to work systematically and cross-functionally, driving assigned tasks to completion.
Supervisory Responsibilities
None
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 is protected.
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 vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—from the standards we make to the partnerships and conversations we cultivate. An environment where every employee feels fully empowered and valued irrespective of, but not limited to, personality, race, ethnicity, physical and mental abilities, education, religion, gender identity and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
Note: 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.
Job Category Administrative
Job Type Full-Time