Pharmaron · 3 hours ago
Sr. Quality Assurance (QA) Specialist II- Early Phase / Kilo Lab
Coventry, Rhode Island, USA, 02816
Full-time
Onsite
Mid, Senior Level
$70K/yr - $80K/yr
2+ years expPharmaron is a global CRO helping pharma and biotech companies bring new therapies to life. They are seeking a Senior Quality Assurance (QA) Specialist II to ensure compliance with quality systems and provide support for quality issues in regulated studies.
BiotechnologyChemicalPharmaceutical
Responsibilities
Comply with the Company's Health and Safety, and Radiation Safety Program
Quality systems - to audit assigned aspects of the Company's regulated activities, with the exception of the Finance Department, and report to Test Site Management any non-compliance to the Company SOPs, protocols, policies, or relevant regulations
Identify critical non-compliances and report them immediately to the Study Lead, Director of Quality Assurance, and Test Site Management
Provide advice and support to assigned functions with regards to quality issues
Schedule and execute audits of plans, data, and reports for accuracy and compliance for regulated studies
Audit laboratory activities performed by operations for compliance
Schedule and execute facility audits of equipment, systems, and processes in compliance with QAU SOPs
Provide, track, and close written audit reports for all auditing activities
Contribute to the Quality Assurance Metrics Report to Management
Provide support for Regulatory and client inspections
Quality Assurance Unit - to adhere to the operations of the QAU and to make recommendations for further implementation or improvement of any of its systems
To prepare standard operating procedures for use by the Company as required
To assist the Company, meet its business objectives by demonstrating to Sponsors the quality processes and continuous improvement activities within the Company
Qualification
Required
Bachelors of Science in Chemistry + 2 years experience working in the regulated pharmaceutical
Experience working in a CRO Quality Department performing auditing
Knowledge of Bioanalysis
Knowledge and ability to apply GLP and Part 11 Code of Federal Regulations, GCP/ICH Guidelines, and other applicable regulations or guidelines
Attention to detail to ensure data and reports are accurate and the study conduct meets protocol
Benefits
Insurance including Medical, Dental & Vision with significant employer contributions
Employer-funded Health Reimbursement Account
Healthcare & Dependent Care Flexible Spending Accounts
100% Employer-paid Employee Life and AD&D Insurance, Short and Long Term Disability Insurance
401k plan with generous employer match
Access to an Employee Assistance Program
Company
Pharmaron
Pharmaron is a contract research organization that offers research and development services for the life science industries.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$907.82MKey Investors
GL Capital
2019-11-22Post Ipo Equity· $587.82M
2019-01-28IPO
2015-12-14Series Unknown· $280M
Leadership Team
Katherine Lee
Chief Business Officer
Recent News
2026-01-16
Precedence Research
2025-11-07
Business Wire
2025-10-29
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