Overview In this role you will serve as the QC compliance SME across analytical chemistry and microbiology, ensuring cGMP/GDP and regulatory alignment while driving inspection readiness and continuous improvement. You collaborate with QA, Manufacturing, Technical Services, and Regulatory Affairs to strengthen quality systems and improve lab performance. You will lead investigations, CAPA effectiveness, and data integrity initiatives, shaping compliant, efficient QC operations in our mission-driven organization. This is an on-site position in Bloomsbury, NJ with a strong focus on impact and cross-functional partnership.
Compensation / Benefits- comprehensive health benefits
- 401k with company match
- paid time off: 12 PTO, 5 PLP, 8 holidays
- occasional weekend/OT with notice
- career growth opportunities
- full-time on-site role in Bloomsbury, NJ
Responsibilities- Serve as the QC compliance SME for analytical chemistry and microbiology laboratories
- Ensure QC activities meet cGMP, GDP, SOPs, and regulatory standards
- Oversee equipment lifecycle management, computer system validation, and data integrity
- Lead compliance initiatives, inspection readiness, and audit outcomes
- Own QC dashboards and KPI monitoring, perform trend analysis and drive corrective actions
- Lead and oversee complex laboratory investigations (OOS/OOT/deviations) ensuring timely, compliant resolutions
- Identify recurring issues and implement CAPAs to prevent recurrence
- Support QA inspections and regulatory audits, and address findings with compliant actions
- Develop and implement QC training programs and technical modules
- Mentor QC scientists and analysts on compliance, foster data integrity and continuous learning
- Drive operations efficiency and process improvements across QC labs
- Support capacity planning, utilization optimization, and strategic projects (e.g., harmonization, system enhancements)
- Author, review, and approve SOPs, protocols, and reports to ensure regulatory compliance
Key requirements- 10+ years of experience in pharmaceutical QC, QA, or compliance within a cGMP environment
- Bachelor in Chemistry, Microbiology, Pharmaceutical Sciences, or related field; Master/PhD preferred
- Significant experience in analytical and/or microbiology operations
- Proven leadership in regulatory inspections, audits, and remediation
- Experience with method validation, stability programs, and lab investigations
- Authorized to work in the United States; no visa sponsorship
- Strong understanding of regulatory standards and industry best practices
- cross-functional collaboration
- excellent communication with regulators and auditors
- attention to detail
- cGMP and GDP knowledge
- FDA 503B regulations
- CFR, Eudralex, ICH, ISO guidance
