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 high‑value 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

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

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
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:

Bachelor's 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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Quality Assurance Specialist III