GMP Documentation Specialist 2

Key Responsibilities

• Independently review and approve GMP documents in the Document Management System, including SOPs, work instructions, electronic batch records, automation documentation, forms, checklists, scanned documents, and related materials.
• Review and approve electronic and paper-based validation and qualification documents, including protocols and summary reports for equipment, instrumentation, maintenance validation, computer systems, and analytical systems.
• Review and approve non-DMS documentation, including preventive maintenance records, CMMS forms, instrument data sheets, functional equivalency memoranda, DMS withdrawal forms, periodic review audit trails, and facility forms.
• Document review observations, suggested edits, and comments clearly and accurately.
• Apply company documentation review procedures to ensure all changes are appropriately justified, accurately reflected, and compliant with applicable requirements.
• Collaborate with internal customers and cross-functional partners to obtain information, resolve documentation issues, and ensure timely completion of assigned work.
• Escalate complex or unresolved quality issues to the Senior QA Specialist, Project Manager, or Quality management as appropriate.
• Participate in routine meetings, data queries, project activities, and report compilation as assigned.
• Apply data integrity principles to all aspects of work in accordance with company policies, guidelines, and procedures.
• Perform other duties and responsibilities as assigned.

Required Qualifications

• Bachelor of Science degree in a science-related discipline or equivalent relevant experience.
• Approximately 5–10 years of experience in Quality Assurance within a biotechnology, pharmaceutical, or other GMP-regulated environment.
• Extensive experience with quality assurance, documentation review, and validation processes.
• Strong understanding of GMP requirements and applicable regulations, including ICH Q7–Q11 and applicable sections of 21 CFR Parts 210, 211, 600–680, and 820.
• Advanced knowledge of Quality Systems, including deviations, change controls, CAPAs, and other quality events.
• Experience reviewing and approving process, equipment, cleaning, computer system, and analytical system validation documentation.
• Proficiency with Microsoft Office applications, including Word, Excel, Outlook, and PowerPoint.
• Strong written and verbal communication skills.
• Ability to manage multiple priorities and complete assignments within required timeframes.
• Demonstrated attention to detail, sound judgment, and decision-making ability.
• Ability to identify issues requiring escalation and take appropriate action with or without detailed guidance.
• Ability to work effectively both independently and collaboratively in a cross-functional environment.
• Business-fluent English communication skills.

Preferred Qualifications

• Experience with company’s CSV validation guidelines, templates, SOPs, and quality procedures.
• Experience with LIMS or similar laboratory and enterprise systems.
• Experience with Document Management Systems, TrackWise, SAP, Syncade, CMMS, or comparable platforms.
• Experience supporting gLIMS, MES, automation, computer system validation, or analytical systems.
• Experience managing or coordinating medium- to large-scale Quality or validation projects.
• Experience working directly with Manufacturing, Quality Control, Engineering, Validation, or technical operations teams.

Pay

The hiring rate for this position is $65 to $70.71 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors.