Pharmaron · 2 hours ago
Sr. Quality Assurance (QA) Specialist II
Coventry, RI
Full-time
Onsite
Senior Level
6+ years expPharmaron is a global leader in life sciences solutions, supporting drug discovery through clinical and commercial manufacturing. The Sr. Quality Assurance (QA) Specialist II will ensure cGMP compliance across analytical laboratories and quality systems, partnering with cross-functional teams to oversee documentation and support audits.
BiotechnologyChemicalPharmaceutical
Responsibilities
Ensure compliance in QC and analytical laboratory operations, including sampling, testing, OOS investigations, and reference standard programs
Review and approve method transfer plans, validation protocols, reports, and reference standard documentation
Oversee stability programs, including protocol approvals, reports, data summaries, and related change controls, deviations, and CAPAs
Support instrument qualification, calibration, maintenance, and software validation activities
Manage contract laboratory and supplier oversight, including audits, quality agreements, deviations, and qualifications
Review analytical data for clinical Phase 1 through commercial API manufacturing
Oversee API release, labeling, and issuance of Certificates of Analysis and Conformance
Conduct risk assessments and implement mitigation strategies
Support coordination and execution within the electronic QMS
Support regulatory inspections, client audits, and internal audit programs
Review and support execution of client quality agreements
Provide timely QA responses to client requests, inquiries, and change controls
Qualification
Required
Bachelor's degree in Chemistry or related field
6+ years of pharmaceutical QA experience
Hands‑on experience with deviations, OOS, CAPAs, and change controls
Strong understanding of ICH Q1, Q2, Q7, Q9
Knowledge of FDA, CFR, USP, Ph. Eur. and related regulations
Experience in risk assessment development and mitigation
Excellent attention to detail with strong written and verbal communication skills
Preferred
Knowledge of GAMP 5 and 21 CFR Part 11 for computer system validation
Experience with phase‑appropriate quality systems
Prior experience supporting audits and inspections
Experience in a CMO/CDMO environment
Benefits
A collaborative, inclusive work culture
Clear opportunities for professional growth and career development
Competitive compensation and benefits package
The chance to make meaningful impact on projects that advance human health
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
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2025-10-29
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