Quality Assurance (Qa) Specialist II

Position: Quality Assurance (QA) Specialist II

Location: Coventry, RI

Salary: Competitive, based on experience

About Pharmaron

Pharmaron is a global CRO (Contract Research Organization) helping pharma and biotech companies bring new therapies to life. With over 21,000 employees worldwide across 23 locations in the US, UK and China, we support drug discovery through to manufacturing with fully integrated, high-quality services.

We're proud of the impact we make and just last year, we supported over 780 discovery projects, 1,000+ CMC programmes, and 1,000+ clinical trials across all phases. Our teams are involved in everything from small molecules, ADC's, biologics, and gene therapies and we work with more than 3,000 global customers. To learn more,

Job Overview

The QA Specialist II plays a key role in ensuring cGMP compliance across analytical laboratories, stability programs, and quality systems supporting 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.

Key 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.

What We are Looking for:

• 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 Qualifications

• 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

Why Pharmaron?

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

Collaborative Culture: You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.

Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package:

• 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

How to Apply:

Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!

As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.