Pharmaron · 15 hours ago
Sr. Quality Assurance (QA) Specialist II
Coventry, Rhode Island, USA, 02816
Full-time
Onsite
Mid, Senior Level
$65K/yr - $75K/yr
2+ years expPharmaron is a global CRO helping pharma and biotech companies bring new therapies to life. The Quality Assurance Associate will work in a GxP compliant Bioanalytical CRO Laboratory, responsible for daily QA duties and supporting the development, implementation, and maintenance of the Quality Management System.
BiotechnologyChemicalPharmaceutical
Responsibilities
Perform administrative and support tasks to assist PLSB Head of Quality in maintaining all key Quality Systems including but not limited to; Document Control, Training and Qualification Management, Deviation and CAPA Management, Audits and Inspections, Equipment Qualification and Management, Archival and Records Management, and tracking and trending
Perform initial intake, documentation, notification, administrative review, tracking, filing, and completion support for records related to the above referenced quality systems
Ensure all records are indexed, labeled, tracked, and filed appropriately in paper and electronic format
Maintain robust cross-referencing tracking tools with required information to support Head of Quality review of trends, risks, issues, and gaps
Provide reports to Lead Quality Specialist of upcoming, outstanding, and incomplete tasks and events
Support PLSB technical and laboratory staff in navigating basic QA procedures and escalate issues to Head of Quality when appropriate
Assist Head of Quality on all assigned projects, including reconciliation and organization of legacy information for increased accuracy, reduced error, closure of historical gaps, and ease of access
Additional duties, as required
Qualification
Required
Two years of Quality Assurance experience within the pharmaceutical or biotechnology industry, in a regulated environment; GLP or other regulatory experience is desired
Strong technical writing skills
Preferred
Bachelor's degree in science, preferably in biology or similar field
ISO 9001:2015 Quality Systems experience, a plus
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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