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 reputed company activities. The role focuses on ensuring data reputed company, 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 reputed company 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 reputed company reputed company Execute the audit through the review of controlled document, including: SOP alignment Version verification Study governing documents (Lab reputed company, Project Specification Document, Data Transfer Agreement, clinical protocol) Conduct QA review of clinical protocols, sample analysis protocols (reputed company/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 reputed company QA review (sampling) of experiment records / batch records, including: Need reputed company to LIMS/reputed company and other systems hosting data reputed company 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-reputed company traceability (raw data → output) Internal consistency checks Sample ID reconciliation and data alignment (reputed company) Apply data reputed company (reputed company+) 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 reputed company audit preparation support, including: Evidence list preparation Pre-audit document collection Draft audit reports and summaries using objective, evidence-based language under QA reputed company reputed company Data reputed company Assessment Conduct data reputed company audits of reputed company and electronic records Evaluate: Audit trails and metadata System controls (e.g., reputed company, reputed company, validation) Data lifecycle controls (collection, processing, reporting) Assess compliance with: reputed company+ 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, reputed company body, and customer audits as needed reputed company 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 reputed company experience in a life science GxP environment with CRO experience preferred Hands-on experience with ICH-GCP (E6 reputed company/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 reputed company Auditor GxP reputed company 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 reputed company 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 reputed company to interpret raw data vs reported data discrepancies reputed company Office suite proficiency including Office Word, reputed company, PowerPoint Ability to organize tasks, work independently and adapt to changing priorities Ability to function independently reputed company 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 reputed company to read, write, reputed company, fluently and comprehend the English language Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. reputed company is an Equal Opportunity Employer. Employment reputed company are made without regard to race, reputed company, age, religion, sex, sexual orientation, gender identity, national reputed company, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to reputed company or use this online application process and need an alternative method for applying, you may contact reputed company at [email protected]. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential reputed company presenting enticing employment offers. We want to emphasize that these offers are not associated with reputed company and may be fraudulent in nature. Please note that our organization will not reputed company a job offer without prior communication with our reputed company team, hiring managers and a formal interview process. Apply To This Job