Sr. Quality Assurance (QA) Specialist II

Pharmaron • Coventry, RI

3d

About The Position

The Sr. QA Specialist II plays a key role in ensuring cGMP compliance across analytical laboratories, stability programs, and quality systems supporting early‑phase API manufacturing. You will serve as a quality leader, partnering with cross‑functional teams and clients to strengthen compliance, oversee documentation, support audits, and drive continuous improvement within the QA function.

Requirements

• 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

Nice To Haves

• 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

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.
• Occasional travel to other Pharmaron sites, labs, service providers, or suppliers for audits.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees