Senior Specialist, Quality Assurance Validation

Key Responsibilities
- Independently review and approve initial Commissioning, Qualification, and Validation (CQV) lifecycle documents and subsequent changes.
- Review and approve periodic reviews, re-qualification, decommissioning/retirement plans, protocols, and summary reports.
- Review and approve SOPs, work instructions, deviations, CAPAs, and change controls for facilities, utilities, equipment, instruments, and systems.
- Provide instruction/guidance on CQV quality issues during regulatory agency inspections, deviations, and CAPA discussions.
- Support the Contract Service Providers program via routine maintenance of associated Quality Agreements.
- Report to management on timely deviation completions, CAPA implementations, and other CQV/CSV issues.
- Support Product Development and Product Development Quality initiatives as needed.
- Escalate to management any information on impacts of policies/procedures/industry quality regulations on quality systems.

Qualifications & Experience
- M.S. or B.S. with 3–5 years’ experience, including 1–3 years in a regulated function.
- Experience as a CQV/QA/QC representative in Pharmaceutical/Drug Substance Manufacturing (API, sterile, non-sterile, or biological), Medical Device Manufacturing, or a Laboratory environment.
- Demonstrated knowledge of cGMP regulations.

Required/Preferred Skills
- Working knowledge of: process control systems; process equipment & utilities; laboratory equipment & instrumentation; packaging & labelling equipment; environmental monitoring systems; supply chain systems.
- Effective interpersonal/organizational skills; demonstrated leadership; MS Office Suite proficiency.

Compensation/Benefits (as stated)
- New Brunswick, NJ (US): $78,980–$95,708 (full-time).
- Health coverage; wellbeing programs; 401(k), disability/life insurance and other protections; Paid Time Off.

Application Instruction
- Apply even if your experience doesn’t perfectly match the role.