Quality Assurance (QA) Specialist II- Early Phase / Kilo Lab

Position: Quality Assurance (QA) Specialist II- Early Phase / Kilo Lab

Location: Coventry

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, visit www.pharmaron.com.

Pharmaron is excited to invite applications for a Sr. QA Specialist II, supporting early‑phase kilo lab manufacturing within our dynamic CDMO environment. If you're 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 Quality Assurance (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, 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.

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

• 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 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.

#LI-PR1

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.