Sr. Quality Assurance QA Specialist II FLSA Status Exempt
Location: Coventry Department: Quality Assurance - Early Phase Kilo Lab Salary: Competitive based on experience
Pharmaron is excited to invite applications for a Sr. QA Specialist II supporting early-phase kilo lab manufacturing within our dynamic CDMO environment. If youre seeking a role with significant impact, cross-functional collaboration, and opportunities to shape the quality framework of early-stage API development, this is the perfect next step in your QA career.
Job Overview
The Sr. QA Specialist II serves as the primary QA contact for all kilo lab operations, ensuring full compliance with cGMP phase-appropriate quality systems and client expectations. This role provides QA oversight of manufacturing activities, analytical method development, stability programs, cleaning verification, and key quality systems supporting early-phase clinical API supply.
You will work closely with manufacturing, analytical development, process chemistry, and client partners to maintain a high standard of compliance and operational excellence.
Key Responsibilities
• Documentation & Compliance • Review and approve batch records, protocols, reports, and analytical data for accuracy and compliance. • Lead QA oversight of deviations, investigations, change controls, OOSOOT, 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.
• Client Interaction • 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.
• Analytical & Stability Oversight • 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.
• Cleaning Program Oversight • 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.
• Continuous Improvement • 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.
Travel Occasional travel to other Pharmaron sites, service providers, or suppliers for audits or quality oversight.
Required Education & Experience
• Bachelors 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 Experience
• 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.
Why Pharmaron
Pharmaron is a global leader in life sciences services, supporting drug discovery through clinical and commercial manufacturing across small molecules, biologics, and advanced modalities. With over 21,000 employees worldwide, our culture is defined by our commitment to our people and customers.
What We Offer
• 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.
Our core values - Employees Number One and Clients Centered - shape everything we do and make Pharmaron a unique place to build your career.
How to Apply
Ready to take the next step in your QA career? Join Pharmaron and help shape the future of early-phase clinical manufacturing. Apply online today.
Pharmaron is an Equal Employment Opportunity employer committed to diversity, inclusion, and workplace excellence.