Sr. Quality Assurance (QA) Specialist II- Early Phase / Kilo Lab
About The Position
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. 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.
Requirements
- 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.
Nice To Haves
- 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.
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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
