Specialist, Quality Assurance

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

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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

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