Specialist, Quality Assurance

Merck•Wilson, NC

5d•$87,300 - $137,400

About The Position

The Specialist, Quality Assurance manages site standard operating procedure (SOP) documentation, including creation, formatting, repository maintenance, review and approval tracking, distribution, retention, numbering, and re-approval. The role supports SOP training communications and updates training requirements and effective dates in the Learning Management System (LMS). It champions the Chapter 10 SOP Management subsystem, monitors system health, and identifies improvements. The position also supports cross-functional Data Integrity projects, performs second-person reviews of Annual Product Reports (APRs), and may assist with other projects as needed to support site business continuity. Learning and Development responsibilities include maintaining training data and reports in the LMS or other authorized tools, entering and archiving training completion records, and assisting with training materials and room setup. The successful candidate will be accurate and well organized, able to coordinate and follow up on outstanding work, prioritize deadlines, manage multiple tasks, and collaborate across the organization. The role is based in Wilson, North Carolina, is a first-shift position, and may require occasional weekend and off-shift hours to support product launches or compliance-driven actions.

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 skills, including formatting and spelling.
Ability to coordinate, log, track, and follow up on outstanding items.
Self-motivation and a strong sense of urgency in meeting timing requirements.
Ability to produce accurate, properly documented work for GMP purposes.
Ability to manage multiple day-to-day tasks and prioritize work based on deadlines and schedule changes.
Ability to achieve objectives requiring cooperation from people throughout the organization.
Willingness to work occasional weekends and off-shift hours to support product launches or compliance-driven actions.
Required skills listed: Audits Compliance, Corrective and Preventive Action (CAPA), Detail-Oriented, Documentation Review, Document Management, Driving Continuous Improvement, GMP Compliance, Good Documentation Practices, Periodic Reviews, Quality Assurance Tools, Quality Management Systems (QMS), Quality Standards, and Records Retention.

Nice To Haves

Bachelor of Science four-year college degree.
Excellent technical writing skills.
Detail-oriented.
Learning and Development experience.
Project management.
Problem solving.
Product Quality Reviews.

Responsibilities

Create and format SOPs, Work Instructions, Setup Sheets, Flowcharts, Forms, and Job Aids.
Maintain controlled documents in the electronic repository and/or applicable electronic Quality Management System (eQMS).
Manage and track document review and approval processes.
Distribute SOPs, Flowcharts, Job Aids, and updated Tables of Contents to departmental area libraries weekly.
Manage distribution of 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 eQMS.
Cascade communications about SOP training.
Update new and revised SOP URLs, effective dates, and training requirements in myLearning LMS.
Manage SOP re-approval processes in the applicable eQMS.
Champion the Chapter 10 SOP Management subsystem, ensure 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 maintain site business continuity.
Use and maintain site training data in the LMS or other authorized tools to manage and monitor training inputs, materials, and reports.
Enter training data in the LMS and maintain hard-copy training completion data and archives.
Assist the L&D Specialist with material reproduction and training room scheduling and setup as needed.
Perform other duties or assignments as needed to compensate for workload shifts.