Specialist, Quality Assurance

MSD•Wilson, NC

3d•$87,300 - $137,400

About The Position

The Specialist, Quality Assurance manages site standard operating procedure (SOP) documentation and related quality records. This includes creating, formatting, maintaining, distributing, tracking, and archiving SOPs, Work Instructions, Setup Sheets, Flowcharts, Forms, and Job Aids in electronic repositories and applicable electronic Quality Management Systems (eQMS), as well as maintaining associated hard-copy libraries. The role manages document review, approval, re-approval, numbering, retention, legal holds, training communications, and learning-system updates. It champions the Chapter 10 SOP Management subsystem, monitoring system health and identifying improvements to maintain site alignment. The position also supports cross-functional Data Integrity projects, performs second-person reviews of Annual Product Reports, and provides limited-resource support for other projects as needed to maintain business continuity. Learning and Development duties include managing site training data and reports in the Learning Management System (LMS) or other authorized tools, entering training data, maintaining hard-copy training records and archives, and assisting with training materials and room setup. The role requires accurate, well-documented work for GMP purposes, coordination and follow-up across the organization, and the ability to manage changing priorities and multiple tasks. Occasional weekend and off-shift work may be required to support product launches or compliance-driven actions. The position is based in Wilson, North Carolina, and is a first-shift role.

Requirements

High School Diploma.
Five years of functional experience in quality document control management.
Excellent proficiency with office software, including MS Word, MS 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-motivated, with a strong sense of urgency to meet timing requirements.
Ability to produce accurate, properly documented work for GMP purposes.
Ability to manage multiple tasks and prioritize based on deadlines and schedule changes.
Ability to achieve objectives requiring cooperation from people across the organization.
Willingness to work occasional weekends and off-shift hours to support product launches or compliance-driven actions.
Required skills include audits and compliance, CAPA, attention to detail, 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 four-year college degree.
Excellent technical writing skills.
Strong attention to detail.
Learning and Development experience.
Project management skills.
Problem-solving skills.
Product Quality Reviews.

Responsibilities

Create and format SOPs, Work Instructions, Setup Sheets, Flowcharts, Forms, and Job Aids.
Maintain controlled documents in electronic repositories and applicable eQMS platforms.
Manage and track document review and approval processes, including SOP re-approvals.
Distribute SOPs, Flowcharts, Job Aids, updated Tables of Contents, and Setup Sheets to the appropriate departmental libraries and packaging lines.
Maintain current and archived central hard-copy libraries for SOPs, Setup Sheets, and Flowcharts.
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 or applicable eQMS.
Cascade communications regarding SOP training and update new and revised SOP URLs, effective dates, and training requirements in the LMS.
Champion the Chapter 10 SOP Management subsystem, maintain site alignment, monitor system health, and identify improvements.
Support cross-functional Data Integrity projects.
Perform second-person reviews of Annual Product Reports (APRs).
Support additional cross-functional projects as assigned to help maintain site business continuity.
Use and maintain site training data, materials, inputs, and reports in the LMS or other authorized tools.
Enter training data in the LMS and maintain hard-copy training completion records and archives.
Assist the L&D Specialist with material reproduction and training-room scheduling and setup as needed.
Perform other duties or accept assignments as needed to address workload shifts.