Job Requisition Summary
Associate III, Quality Systems
The Associate III, Quality Systems will play a critical role in supporting the transition of Quality Control Data Management activities from Labware Laboratory Information Management Systems (LIMS) to SAP Quality Management (SAP QM). This position will be responsible for reviewing, revising, and creating controlled quality documentation to align with new SAP QM business processes. The individual will collaborate with Quality Control, Quality Assurance, and cross-functional teams to ensure all procedures, workflows, and training materials accurately reflect the new operating system while maintaining compliance with GMP and company quality standards.
This role will manage document lifecycle activities within Veeva Vault, support change control activities associated with the system transition, coordinate training assignments, and ensure documentation compliance throughout implementation and post-go-live activities.
Key Responsibilities
- Review existing controlled documents and identify references to Labware LIMS requiring revision for SAP QM implementation.
- Revise SOPs, work instructions, forms, and associated quality documents to reflect SAP QM processes.
- Author new SOPs and process documents supporting new SAP QM workflows and QC data management activities.
- Coordinate documentation deliverables required to support change control closure.
- Ensure document compliance, traceability, version control, and training requirements are met throughout the document lifecycle.
- Partner with business process owners and SMEs to document future-state workflows.
- Translate process maps and business requirements into compliant procedural documentation.
- Maintain documentation systems and records in accordance with GMP and company requirements.
- Other assigned duties deemed appropriate withing the position scope
Preferred Qualifications
- Experience supporting implementation or migration projects involving Labware LIMS, SAP QM, or other quality systems.
- Knowledge of change control, deviation management, and training processes.
- Experience within pharmaceutical, biotechnology, animal health, or other regulated manufacturing environments.
- Document Coordinator certification or similar document control certification preferred.
Experience
- Experience managing controlled documentation within a regulated GMP environment.
- Experience authoring and revising SOPs, work instructions, and quality system documents.
- Experience supporting change controls and quality system processes.
- Experience with electronic document management systems preferred.
- Experience with Veeva Vault, Labware, SAP, TrackWise, or similar quality systems strongly preferred.
- Experience supporting laboratory or quality control processes preferred.
Skills
- Strong proficiency with Microsoft Office Suite (Word, Excel, Outlook).
- Working knowledge of SAP and/or SAP Quality Management (SAP QM).
- Experience with Veeva Vault document management workflows.
- Knowledge of document control systems and quality records management.
- Familiarity with GMP, quality systems, and compliance requirements.
- Excellent technical writing and SOP authoring skills.
- Strong attention to detail and document accuracy.
- Ability to interpret process flows and convert them into clear procedural documentation.
- Strong organizational and project management skills.
- Effective verbal and written communication skills.
- Ability to collaborate across multiple departments and stakeholders.
- Ability to manage multiple document revisions and competing priorities simultaneously.
Education
- High School Diploma with a minimum of five (5) years of relevant experience; OR
- Associate Degree from an accredited institution with a minimum of three (3) years of relevant experience.