Pharmaron · 2 hours ago
Sr. Quality Assurance (QA) Specialist II- Early Phase / Kilo Lab
Coventry, RI
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expPharmaron is a global leader in life sciences services, supporting drug discovery through clinical and commercial manufacturing. They are seeking a Sr. QA Specialist II to ensure compliance with cGMP and quality systems in early-phase kilo lab manufacturing, providing oversight for various quality assurance activities and collaborating with cross-functional teams.
BiotechnologyChemicalPharmaceutical
Responsibilities
Review and approve batch records, protocols, reports, and analytical data for accuracy and compliance
Lead QA oversight of deviations, investigations, change controls, OOS/OOT, and CAPA activities related to kilo lab operations
Approve COAs, quality statements, and data summaries per client agreements
Support and ensure readiness for internal and external audits
Serve as the primary QA point of contact for clients during kilo lab projects
Participate in client meetings, teleconferences, and audits to provide QA updates and ensure alignment with project expectations
Review and approve client‑provided documentation and specifications
Support timely QA response to client inquiries, deviations, and change requests
Provide QA oversight for analytical method development, qualification, validation, and transfer
Review analytical protocols, reports, and supporting data to ensure compliance
Oversee stability program design, execution, documentation, and investigations in accordance with ICH guidelines
Oversee cleaning verification for kilo lab equipment and facilities
Review and approve cleaning documentation in alignment with cGMP requirements
Support investigations into cleaning failures or residues to ensure cross‑contamination control
Identify and drive process improvements that enhance compliance and operational efficiency
Support SOP development, updates, and training for kilo lab and analytical teams
Foster a collaborative, quality‑driven culture aligned with cGMP requirements for early‑phase API manufacturing
Occasional travel to other Pharmaron sites, service providers, or suppliers for audits or quality oversight
Qualification
Required
Bachelor's degree in Chemistry, Engineering, Pharmaceutical Sciences, or related field
8+ years of QA experience in the pharmaceutical or biotech industry
Strong understanding of phase‑appropriate quality systems for early‑stage clinical manufacturing
Experience with analytical method development, stability programs, and cleaning verification
Knowledge of FDA, CFR, USP, Ph. Eur., and ICH guidelines including Q1, Q2, Q7, Q9
Excellent communication, organization, and cross‑functional collaboration skills
Able to work independently in a fast‑paced, dynamic environment
Preferred
Prior experience in a CDMO with customer‑facing responsibilities
Experience supporting IND‑enabling activities and early‑phase clinical supply
Familiarity with electronic quality systems and digital documentation tools
Benefits
A collaborative, inclusive environment where your voice is valued
Meaningful work that directly impacts patient outcomes
Career development and internal mobility opportunities
Competitive compensation and benefits
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
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2025-10-29
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