DirectJobHub
Jobs · Quality Assurance · North Carolina

Specialist, Quality Assurance

· Wilson, NC · 1 wk ago
Quality Assurance$87k–$137k/yrFull-time

About the role

This position manages Standard Operating Procedure (SOP) documentation and training data for the Wilson manufacturing site. Core duties include creating, formatting, and maintaining SOPs, Work Instructions, Setup Sheets, Flowcharts, Forms, and Job Aids in an electronic repository and/or electronic Quality Management System (eQMS); managing review and approval workflows; distributing controlled documents to departmental libraries and packaging lines; maintaining hard‑copy libraries (current and archived); applying records‑retention rules and legal holds; issuing SOP/FC numbers; administering the Manufacturing Division Wilson Procedures Workgroup in the eQMS; cascading SOP training communications; updating training URLs and effective dates in the myLearning LMS; managing SOP re‑approval processes; and championing the Chapter 10 SOP Management subsystem. The role also supports cross‑functional Data Integrity projects, performs second‑person review of Annual Product Reports, and assists with Learning & Development activities such as LMS data entry, training material reproduction, and training room scheduling.

Responsibilities

  • Create and format SOPs, Work Instructions (WIs), Setup Sheets, Flowcharts, Forms, and Job Aids.
  • Maintain SOPs, Setup Sheets, Flowcharts, Forms, and Job Aids in electronic repository and/or eQMS.
  • Manage and track Review and Approval Processes within electronic repository and/or eQMS.
  • Manage weekly distribution of SOPs, Flowcharts, Job Aids, and updated Table of Contents to departmental area libraries.
  • Manage distribution of setup sheets to packaging lines.
  • Maintain Central SOP/Setup Sheet and Flowchart hard‑copy libraries (current and archived).
  • Manage documents per records‑retention requirements and identify Legal Holds.
  • Issue and manage SOP/FC numbers for the site.
  • Manage Manufacturing Division Wilson Procedures Workgroup in electronic repository and/or eQMS.
  • Cascade communications for SOP Training.
  • Update New & Revised SOP URLs with current Effective Dates and Training Requirements in myLearning (LMS).
  • Manage SOP re‑approval processes for SOPs in applicable eQMS.
  • Champion the Chapter 10 subsystem (SOP Management), ensuring site alignment; monitor system health and identify improvements.
  • Support Data Integrity cross‑functional projects.
  • Perform second‑person review of Annual Product Report(s) (APR).
  • Support additional cross‑functional projects assigned on a need‑by‑basis for business continuity.
  • Utilize and maintain site training data within the LMS (or other authorized tools) to manage and monitor training inputs, materials, and reports.
  • Perform training data entry in the LMS and maintain hard‑copy training completion data, including archives.
  • Assist L&D Specialist with material reproduction, training room scheduling, and setup as needed.

Requirements

  • High School Diploma (minimum); Bachelor of Science 4‑year College Degree preferred.
  • 5 years functional experience in quality document control management.
  • Excellent office software proficiency: MS Word, MS Excel, Visio, Adobe Acrobat.
  • Willingness to work occasional weekends and off‑shift hours to support product launches or compliance‑driven actions.
  • Excellent typing, formatting, and spelling skills.
  • Ability to coordinate, log, track, and follow up on outstanding items.
  • Self‑motivated with strong sense of urgency to meet timing requirements.
  • Work must be accurate and properly documented for GMP purposes.
  • Ability to manage multiple tasks daily and prioritize based on deadlines and schedule changes.
  • Ability to achieve objectives requiring high cooperation across the organization.
  • Preferred: Excellent technical writing skills, detail orientation, Learning & Development experience, project management, problem solving.

Skills

  • Required: 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, Records Retention.
  • Preferred: Product Quality Reviews.

Pay

Salary range for the primary location (USA – North Carolina – Wilson): $87,300.00 – $137,400.00 per year. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. Compensation varies based on education, qualifications, certifications, experience, skills, geographic location, government requirements, and business needs.

Benefits

Comprehensive benefits package including medical, dental, and vision healthcare and other insurance benefits (for employee and family), retirement benefits (401(k)), paid holidays, vacation, and compassionate and sick days. More details at https://jobs.merck.com/us/en/compensation-and-benefits.

Schedule

  • Shift: 1st – Day
  • Travel: No travel required
  • Flexible Work Arrangements: Not Applicable
  • Occasional weekends and off‑shift hours may be required for product launches or compliance actions.

Location

Primary location: USA – North Carolina – Wilson. Additional locations may have different compensation guidelines; see posting for details.

Similar jobs