Sr. Quality Assurance; QA Specialist II

Overview

FLSA Status: Exempt

Location: Coventry

Department: Quality Assurance

Salary: Competitive, based on experience

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.

• Analytical & Quality Control Oversight
  • 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.
• Quality Systems & Manufacturing Support
  • 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.
• Audits & Client Interaction
  • 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.
• Travel
  • Occasional travel to other Pharmaron sites, labs, service providers, or suppliers for audits.

• 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

• 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

Pharmaron is a global leader in life sciences solutions, supporting drug discovery through clinical and commercial manufacturing across small molecules, biologics, and advanced modalities. With over 21,000 employees globally
, our commitment to "Employees Number One" and "Clients Centered" drives our culture and success.

• A collaborative, inclusive work culture
• Clear opportunities for professional growth and career development
• Competitive compensation and benefits package
• The chance to make meaningful impact on projects that advance human health

Take the next step in your QA career and join a team committed to excellence in early‑phase development and clinical manufacturing.
Apply today!

Pharmaron is proud to be an Equal Employment Opportunity employer, fostering an inclusive workplace where all individuals can thrive.

Pharmaron (Stock Code: 300759.SZ/3759.HK) is a premier R&D 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 19,000 employees, and operations in China, the U.S., and the U.K., Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China.

Pharmaron is proud to be an Equal Employment Opportunity and Affirmative Action employer.