Specialist, Quality Assurance

Merck; North Carolina; Presencial; USD 60.000 - 90.000; Tempo integral

Resumo da vaga

Merck is seeking a Quality Documentation Specialist to manage SOPs, WIs, Setup Sheets, Flowcharts and related job aids. The role includes maintaining electronic and hard-copy libraries, coordinating approvals, and ensuring alignment with GMP standards.

Training updates and communications will be cascaded to the site teams. Responsibilities include managing data integrity and cross-functional support projects, with attention to retention policies and rapid response to regulatory actions.

Qualificações

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

Responsabilidades

• Create and format SOPs, WIs, Setup Sheets, Flowcharts, Forms and Job Aids.
• Maintain SOPs, Setup Sheets, Flowcharts, Forms, and Job Aids in eQMS or other repositories.
• Manage and track Review and Approval processes in the eQMS.
• Distribute SOPs, Flowcharts, Job Aids, and update Table of Contents weekly to department libraries.
• Distribute Setup Sheets to packaging lines and maintain central hardcopy libraries.

Conhecimentos

Typing skills

Coordination and tracking

Self-motivation

GMP documentation

Multi-tasking

Prioritization

Formação

High School Diploma

B.Sc. degree (Preferred)

Ferramentas

MS Word

MS Excel

Visio

Adobe Acrobat

Descrição da vaga

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

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 Reviews

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.

Equal Employment Opportunity Statement:

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:

EEOC Know Your Rights

EEOC GINA Supplement

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