Quality Assurance Specialist III

Position Summary:

The QA Specialist provides independent Quality support for GLP and GCLP studies by performing document review protocol and experiment record review data review and quality event oversight activities. The role focuses on ensuring data integrity traceability and compliance with internal SOPs and applicable regulatory expectations while maintaining strict independence from study execution.

This position includes highvalue QA activities that can be performed remotely with controlled system access and clear separation from operational responsibilities.

Essential duties include but are not limited to:

1. Study-Audit Support

Support execution of internal audits by:

• Create study-specific audit schedule prior to First patient-in (FIP) for study-specific audit
• Create audit plan execute and draft the report for each scheduled audit (interim or associated with the final report) using objective evidence-based language under QA lead oversight

• Execute the audit through the review of controlled document including:
• SOP alignment
• Version verification
• Study governing documents (Lab manual Project Specification Document Data Transfer Agreement clinical protocol)
• Conduct QA review of clinical protocols sample analysis protocols (SAP/SAR) and amendments ensuring:
• Version verification
• Internal consistency
• Alignment with study objectives and SOPs
• Assure closure of quality events pertaining to study at the time of data reporting
• Perform QA review (sampling) of experiment records / batch records including:
• Need access to LIMS/BSI and other systems hosting data source
• Ensure alignment between protocol-defined activities and recorded execution
• Training status of staff
• Qualification status of equipment and reagents
• Conduct QA review (sampling) against DTA of data tables listings and summaries including:
• Table-to-source traceability (raw data output)
• Internal consistency checks
• Sample ID reconciliation and data alignment (BSI)
• Apply data integrity (ALCOA) principles during review of electronic data systems

1. Computerized Systems Audit Support

• Support execution of internal audits by:
• Preparing audit checklists
• Compiling pre-audit document packages
• Assisting with document-based audit reviews
• Provide audit preparation support including:
• Evidence list preparation
• Pre-audit document collection

• Draft audit reports and summaries using objective evidence-based language under QA lead oversight

1. Data Integrity Assessment

• Conduct data integrity audits of paper and electronic records
• Evaluate:
• Audit trails and metadata
• System controls (e.g. access security validation)
• Data lifecycle controls (collection processing reporting)
• Assess compliance with:
• ALCOA principles
• 21 CFR Part 11 / Annex 11 for electronic systems
• Identify:
• Data discrepancies manipulation risks or gaps
• System vulnerabilities affecting data reliability

Miscellaneous:

• Assist in training new and existing personnel as needed
• Participate in regulatory notified body and customer audits as needed
• Provide back-up coverage for other Quality Specialists
• Carry out other duties/projects as assigned

Qualifications:

Minimum Required:

• Bachelors Degree or Master Degree in Life Sciences Pharmacy Biology Chemistry
• 4 years of related experience in a life science GxP environment with CRO experience preferred
• Hands-on experience with
• ICH-GCP (E6 R2/R3)
• FDA regulations (e.g. 21 CFR Part 11)
• EMA / EU CTR / Annex 11
• GxP frameworks (GCP GMP GLP GCLP)

Preferred certification

• ASQ Certified Quality Auditor (CQA)
• ISO 9001 / ISO 13485 Lead Auditor
• GxP Lead Auditor certifications (e.g. CQI/IRCA)
• Clinical QA certifications (e.g. CCQAP)

Other Required:

• High attention to detail
• Strong written and verbal communication
• Ability to meet deadlines and perform administrative functions
• Data review expertise across computerized systems including LIMS
• Understanding of Audit trails metadata and system validation
• Knowledge of Computer System Validation (CSV) and Computer System Assurance (CSA)
• Data governance frameworks
• Must be able to interpret raw data vs reported data discrepancies
• Microsoft Office suite proficiency including Office Word Excel PowerPoint
• Ability to organize tasks work independently and adapt to changing priorities
• Ability to function independently within a minimally supervised environment with exceptional attention to detail required
• Demonstrated highly developed communication skills including well-developed writing skills and verbal and interpersonal skills
• Must be able to read write speak fluently and comprehend the English language

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