Senior QA Documentation Specialist

Creative Solutions Services, LLC; Portsmouth (NH); On-site; USD 90,000 - 120,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a QA Specialist III to review and approve GMP documentation across Manufacturing, Validation, MES, and Quality Control. This role serves as SME for QA document review of equipment/instrumentation, validation maintenance, and computer/analytical systems.

You will interact with QA Specialists, PMs, and management, ensuring superior internal customer service and escalating items as required.

Qualifications

• Bachelor of Science.
• Advanced - 5-10 years in quality assurance and validation processes.
• Strong understanding of CSV validation guidelines, templates, and SOPs.

Responsibilities

• Review and approve documents (SOPs, work instructions, eBR, forms) in the Document Management System.
• Review non-DMS documents (CMMS forms, instrument data sheets, memos).
• Follow documentation revision procedures and escalate issues as needed.
• Participate in routine meetings and data queries; compile reports.
• Apply Data Integrity principles in all aspects of work per Lonza DI policies.
• Assist with quality systems and regulatory compliance.

Skills

GMP knowledge

Quality assurance

Validation processes

Project management

Data integrity

Education

Bachelor of Science

Tools

LIMS

TrackWise

SAP

Syncade

Job description

Creative Solutions Services, LLC is seeking a QA Specialist III to review and approve GMP documentation across Manufacturing, Validation, MES, and Quality Control. This role serves as SME for QA document review of equipment/instrumentation, validation maintenance, and computer/analytical systems.

You will interact with QA Specialists, PMs, and management, ensuring superior internal customer service and escalating items as required.