Sr. Quality Assurance (QA) Specialist II

Pharmaron•Coventry, RI

About The Position

Pharmaron is excited to invite applications for a Sr. Quality Assurance (QA) Specialist II , supporting Quality Control, Analytical Operations, and the Stability Program within our dynamic CDMO environment. If you are driven by high standards, thrive in a collaborative scientific setting, and enjoy ensuring compliance for manufacturing, this role offers the challenge and impact you're looking for. The Sr. 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.

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.