New · posted Nov 5
Merck · Pharmaceuticals
Specialist, Quality Assurance
- Wilson, NC
- On-site
- Full-time
- Associate & Specialist
What you need
Education Minimum Requirement
- High School Diploma
- Bachelor of Science 4-year College Degree (Preferred)
Required Experience and Skills
- Functional experience in quality document control management. (5 years)
- Excellent office software proficiency (MS Word, MS Excel, Visio, and Adobe Acrobat)
- Must be willing to work occasional weekends and off shift working hours to support product launches or compliance driven actions
Required Skills
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
Travel Requirements
No Travel Required
Preferred Experience and Skillsnice to have
- Excellent technical writing skills
- Detailed Oriented
- Learning and Development
- Project management
- Problem solving
VETJOBS
Preferred Skillsnice to have
Product Quality Reviews
Current Employees apply HERE
Current Contingent Workers apply HERE
Competencies/Leadership Behaviors/Skills
- Excellent typing skills – formatting, spelling, etc.
- Ability to coordinate, log, track, and follow-up on outstanding items.
- Self-motivated with a strong sense of urgency to meet timing requirements.
- Work must be accurate and properly documented for GMP purposes.
- Must be able to manage multiple tasks day to day.
- Ability to achieve objectives requiring a high level of cooperation from others throughout the organization.
- Must be able to prioritize tasks based on deadlines and schedule changes.
- Employees are expected to perform other duties or to accept other assignments to compensate for workload shifts as the need arises in addition to the major responsibilities listed above.
What you'll do
Standard Operating Procedure management core responsibilities include
- Creating and formatting SOPs, Work Instructions (WIs), Setup Sheets, Flowcharts, Forms and Job Aids.
- Maintaining SOPs, Setup Sheets, Flowcharts, Forms and Job Aids in electronic repository and/or applicable electronic Quality Management System (eQMS).
- Managing and tracking Review and Approval Processes within electronic repository and/or applicable electronic Quality Management System (eQMS).
- Managing weekly distribution of SOPs, Flowcharts, Job Aids and updated Table of Contents to departmental area libraries.
- Managing distribution of setup sheets to packaging lines.
- Maintaining the Central SOP/Setup Sheet and Flowchart hard copy Libraries – current and archived.
- Managing documents per records retention requirements and identifying Legal Holds.
- Issuing and management of SOP/FC numbers for the site.
- Managing our Manufacturing Division Wilson Procedures Workgroup in electronic repository and/or applicable electronic Quality Management System (eQMS).
- Cascading communications for SOP Training.
- Updating New & Revised SOP URLs with current Effective Dates and Training Requirements in myLearning (Learning Management System (LMS)).
- Manage SOP re-approval processes for SOPs in applicable electronic Quality Management System (eQMS).
- Champions the Chapter 10 subsystem, SOP Management, ensuring site alignment. Monitors system health and identifies system improvements.
Cross-functional team support responsibilities, but not limited to
- Responsible for supporting Data Integrity cross functional projects.
- Responsible for performing second person review of Annual Product Report(s) (APR).
- Responsible for supporting any additional cross functional projects that are assigned on need-by-basis that require limited time resource support to achieve business continuity at the site.
Learning and Development core responsibilities
- Utilizes and maintains site training data within the Learning Management System (LMS), or other authorized tools, to manage and monitor training inputs, materials, and reports.
- Performs training data entry functions within the LMS and maintains hardcopy training completion data, including archives.
- Assists L&D Specialist with material reproduction and training room scheduling and setup as needed.
Pay and benefits
$87,000 – $137,000 a year
Employer providedAdditional location(s) Compensation Information
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Medical, dental and vision insurance
401(k) retirement benefits
Paid holidays
Vacation
Sick and compassionate days
Annual bonus and long-term incentive
Where you'll work
Wilson, NCOn-siteOpen in Maps (opens in a new tab)
More jobs in Wilson, NCWorking conditions
1st - Day
Hazardous Material(s)
NA
Employee Status
Regular
Relocation
No relocation
VISA Sponsorship
No
Flexible Work Arrangements
Not Applicable
Job Posting End Date
11/12/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Equal opportunity, accessibility and legal noticesMerck's statements, word for word
US and Puerto Rico Residents Only
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
The primary location for this posting is:
USA - North Carolina - Wilson
Where required by law, the compensation range for this role is provided below.
The salary range for the primary location of this role is:
$87,300.00 - $137,400.00
This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Job intelligence
The context around this role
Live data · November 5, 2026
Salary intelligence
How the pay compares
This role's midpoint is 24% above the US median for Quality Systems & Document Control roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US16 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $87,000 | — | $137,000 |
| All US (middle half) | $67,000 | $90,000 | $106,375 |
This role: Merck's own published range. Comparisons: the base pay employers published on open Quality Systems & Document Control roles at the same level on Regulatory Jobs, November 5, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Systems & Document Control
The general path across 81 open Quality Systems & Document Control roles on Regulatory Jobs, with the titles they carry most. Not Merck's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 43 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs17
- Quality systems and risk5
- Collaboration and leadership5
- GMP and compliance3
- Data and digital systems2
- Investigations and CAPA1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Systems & Document Control work in pharmaceuticals, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and AnswersNamed in the posting
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- ISOISO 9001(official source, opens in a new tab)Quality management systems requirements
- WHOWHO good manufacturing practices(official source, opens in a new tab)World Health Organization GMP norms and standards for medicines
Company hiring pulse
Merck on Regulatory Jobs
- 40
- Open roles
- 40
- Distinct roles
- 7
- Locations
By discipline
- Clinical29 73%
- Quality6 15%
- Regulatory5 13%
By level
- Director29 73%
- Associate & Specialist5 13%
- Senior & Principal4 10%
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Specialist, Quality Assurance at Merck
Applications close November 12. $87K–$137K a year, employer provided.