GMP Documentation Specialist 2

Position Summary:

• The QA Specialist III is responsible for reviewing and approving GMP documentation supporting site operations, including Manufacturing, Validation, Manufacturing Execution Systems (MES), Quality Control, equipment and instrumentation, maintenance validation, and computer and analytical systems.
• This position serves as a Quality Assurance subject matter expert for documentation review and supports customer-specific documentation and project activities.
• The QA Specialist III works closely with QA Specialists, QA Project Managers, Quality leadership, and cross-functional stakeholders to identify, resolve, and escalate quality issues in accordance with company procedures and regulatory requirements.
• The role requires strong attention to detail, sound judgment, effective communication, and a commitment to data integrity and customer service.

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.

Key Stakeholders:

This position will regularly interact with:

• Quality Control
• Global gLIMS Team
• Manufacturing Operations
• Validation and Engineering
• Quality Assurance Project Managers
• Quality and Site Management
• Internal customers and project teams

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.

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.

Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, Sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.