Quality System Associate

At USP we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship professional development and leadership opportunities. Our partnerships standards and research reflect our belief that ensuring broad participation in scientific leadership results in stronger more impactful outcomes for global health.

USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair merit-based selection processes that enable the best scientific mindsregardless of backgroundto contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment.

Brief Job Overview

This is a hands-on non-supervisory professional position that supports the important work of USPs Quality Assurance Activities. The Quality systems Associate is the expert in management of the tool of Quality Management System (MasterControl) including 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 managing user accounts organizing maintaining and updating all controlled documents and ensuring training is assigned and executed in a timely manner. The Quality System Associate trains all levels of users in QMS tool and collaborates with all departments to maintain a compliant document management/training system and meet business needs. This position works independently with minimal supervision to accomplish daily tasks by efficiently and effectively utilizing the Companys QMS tool. The Quality System Associate will drive continuous improvement within the system and create/report metrics regarding document status priority change management training completion and issue management. This position is also leading/supporting workflow development by utilizing the QMS tool to enhance the quality system and improve the process efficiency.

This position is also responsible for performing documentation review/release of lab projects batch records and equipment qualification. This position will also support the Global Supplier Quality Management Program.

How will YOU create impact here at USP

As part of our mission to advance scientific rigor and public health standards you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity regulatory excellence and evidence-based decision-making to ensure health systems worldwide can rely on strong tested and globally relevant quality standards.

Additionally USPs People and Culture division in partnership with the Equity Office invests in leadership and workforce development to equip all employees with the skills to create high-performing inclusive teams. This includes training in equitable management practices and tools to promote engaged collaborative and results-driven work environments.

The Quality System Associate has the following responsibilities:

Document Control activities (at least 50%) :

• The Quality System Associate is the QMS tool 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. Review of Standard Operating Procedures (SOPs) and other documentation including work instructions to ensure accuracy and compliance.
• Manages QMS tool 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 QMS tool(s). 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 issue management and user management.
• Develop improve workflows in the QMS tool to enhance the efficiency of processes.
• Develops/maintains/reports metrics periodically regarding document management training issue management user management. 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 SMEs and MasterControl Customer Support Team to resolve any application issues/glitches for a quick resolution.
• Assumes other responsibilities as assigned by
• Adhere and promote USP core values & DEIB (Diversity Equity Inclusion and Belonging) within the department and throughout the organization.

Other QA activities (not more than 50%):

• Review/approve the following QA activities
• Equipment IQ/OQ/PQ documents
• Equipment calibration documents
• Quality-related issues complaints deviations and investigations with appropriate corrective/preventive actions.
• Review/approval of technical and analytical documents of moderate to high complexity for Reference Standards and/or Analytical Reference Materials (ARM)
• Batch Records
• Lab data projects
• Support the Supplier Quality Management program by conducting supplier evaluations audits and supplier performance/metrics.
• Other assignments as required

Who is USP 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 degree in Science( Chemistry/) with 5-7 years relevant experience in a pharmaceutical industry preferably working in QA Document Control function/Analytical Reviewer role/Quality Control in API or formulations industry.
• 1-2 years of document control experience in a pharmaceutical biotech or other regulated industry
• Hands-on experience in laboratory handling of analytical equipment qualification of analytical equipment calibration metrology and other laboratory activities is preferable.
• Strong computer working knowledge of MS Word PowerPoint Excel etc.
• 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

• Experience in managing QMS tool(s) as an Administrator
• Understanding of GMP GLP and ISO regulations and the integration of the regulations into working systems in the laboratory.

• Excellent written and verbal communication skills including well-developed interpersonal skills used to influence the behavior of others.
• Any diploma in computers or relevant QA/QC/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.
• Strong knowledge of MS office tools such as Word Excel and power point presentation.

Supervisory Responsibilities

None

Benefits

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

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 specificwritten agreement with USP

Required Experience:

IC