Specialist, Quality Assurance

MSD•Wilson, NC

About The Position

The Specialist, Quality Assurance manages site standard operating procedure (SOP) documentation and related quality-system processes. The role creates, formats, maintains, distributes, and archives SOPs, work instructions, setup sheets, flowcharts, forms, and job aids in electronic repositories and/or an electronic Quality Management System (eQMS). It coordinates document review and approval, SOP re-approvals, document numbering, records retention and legal holds, hard-copy libraries, training communications, and updates to SOP information in the Learning Management System (LMS). The specialist champions the SOP Management subsystem, supports system health and improvement, and manages the Wilson Procedures Workgroup. The position also supports cross-functional work, including data integrity projects and second-person review of Annual Product Reports. Learning and Development responsibilities include maintaining training data and records, entering training information in the LMS, and assisting with training materials and room setup. Other duties or assignments may be added as workload needs change. The primary location is Wilson, North Carolina. The role is a regular employee position, has a first-shift/day designation, and requires occasional weekend and off-shift work to support product launches or compliance-driven actions. No relocation, visa sponsorship, or travel is offered or required. The listed base salary range for the primary location is $87,300–$137,400, with eligibility for an annual bonus and long-term incentive, if applicable.

Requirements

High school diploma.
Five years of functional experience in quality document control management.
Excellent proficiency with office software, including Microsoft Word, Microsoft Excel, Visio, and Adobe Acrobat.
Excellent typing and document-formatting skills, including spelling accuracy.
Ability to coordinate, log, track, and follow up on outstanding items.
Self-motivation and a strong sense of urgency to meet timing requirements.
Ability to produce accurate, properly documented work for GMP purposes.
Ability to manage multiple day-to-day tasks and prioritize based on deadlines and schedule changes.
Ability to achieve objectives requiring cooperation across the organization.
Willingness to work occasional weekends and off-shift hours to support product launches or compliance-driven actions.
Required skills include audits, compliance, CAPA, detail orientation, documentation review, document management, continuous improvement, GMP compliance, good documentation practices, periodic reviews, quality assurance tools, QMS, quality standards, and records retention.

Nice To Haves

Bachelor of Science or other four-year college degree.
Excellent technical writing skills.
Detail-oriented approach.
Learning and Development experience.
Project management skills.
Problem-solving skills.
Experience with product quality reviews.

Responsibilities

Create and format SOPs, work instructions, setup sheets, flowcharts, forms, and job aids.
Maintain controlled documents in electronic repositories and/or an applicable eQMS.
Manage and track document review and approval processes, including SOP re-approvals.
Distribute SOPs, flowcharts, job aids, and updated tables of contents to departmental area libraries weekly.
Distribute setup sheets to packaging lines.
Maintain current and archived central hard-copy SOP, setup-sheet, and flowchart libraries.
Manage documents according to records-retention requirements and identify legal holds.
Issue and manage site SOP and flowchart numbers.
Manage the Manufacturing Division Wilson Procedures Workgroup in the electronic repository and/or applicable eQMS.
Cascade communications for SOP training and update new and revised SOP URLs, effective dates, and training requirements in the LMS.
Champion the Chapter 10 SOP Management subsystem and ensure site alignment.
Monitor system health and identify system improvements.
Support cross-functional data integrity projects.
Perform second-person review of Annual Product Reports.
Provide limited-time support for other assigned cross-functional projects to help maintain business continuity.
Use and maintain site training data in the LMS or other authorized tools, including training inputs, materials, and reports.
Enter training data in the LMS and maintain hard-copy training completion records and archives.
Assist the Learning and Development Specialist with material reproduction and training-room scheduling and setup as needed.
Perform other duties or assignments as needed to address workload shifts.