Specialist, Quality Assurance

MSD; Wilson (NC); On-site; USD 87,000 - 137,000; Full time

Benefits offered by this job

401(k) retirement benefits

Medical, dental, vision insurance

Paid holidays and vacation

Job summary

MSD is seeking a qualified professional to manage SOPs, WIs, and change control within the eQMS for a Wilson, NC site. You will steward document control, training alignment, and cross-functional support to ensure GMP compliance.

Responsibilities include maintaining document libraries, performing second-person reviews, and driving data integrity initiatives across the organization. A science/quality background and strong writing skills are essential.

Qualifications

• Functional experience in quality document control management (5 years).
• Excellent office software proficiency (MS Word, MS Excel, Visio, Adobe Acrobat).
• Willing to work occasional weekends and off shift hours to support launches or compliance actions.

Responsibilities

• Managing SOP/Setup Sheet/Flowchart libraries and change control in eQMS.
• Overseeing training mappings and LMS data related to SOPs and revisions.
• Performing second-person reviews of Annual Product Reports (APR).
• Supporting cross-functional projects to sustain business continuity at the site.

Skills

Audits

Compliance

CAPA

Document Management

GMP

QMS

Records Retention

Detail-Oriented

Problem Solving

Cross-functional coordination

Education

Bachelor of Science 4-year College Degree (Preferred)

High School Diploma

Tools

MS Word

MS Excel

Visio

Adobe Acrobat

Job description

**Job Description****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.**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.**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**Preferred Experience and Skills:*** Excellent technical writing skills* Detailed Oriented* Learning and Development* Project management* Problem solving#MSJRVETJOBS**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**Preferred Skills:**Product Quality ReviewsCurrent Employees applyCurrent Contingent Workers apply**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 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.The primary location for this posting is:USA - North Carolina - WilsonWhere 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 - $137,400.00This 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 .**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.**Additional 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**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