Quality Control Compliance Investigator responsible for managing Deviations, NCMRs, CAPAs, and OOS investigations within the Quality Control department.
Requirements
- Bachelor's degree in a science related field
- Minimum 8 years' experience in a cGMP environment
- 1-3 years' experience managing Quality Systems
- 1-3 years' experience with Master Control (preferred)
- 1-3 years of hands on experience in executing quality control analyses (preferred)
- Strong ability to critically assess SOPs, investigations, and project protocols for regulatory compliance
- Proficient in preparing internal reports, technical content, and data summaries with sound conclusions
- In-depth knowledge of cGMPs, 21 CFR Parts 210 and 211, ICH Q7, and USP–NF standards
- Solid understanding of risk management principles and their application in quality systems
- Advanced Excel skills, including the ability to create charts and graphs for data visualization
- Excellent written and verbal communication skills; able to work effectively in team environments
- Proficient in Microsoft Office applications, including Word, Excel, and PowerPoint
- Strong organizational and multitasking abilities; thrives in fast-paced, deadline-driven settings
- Capable of influencing and managing projects in a cross-functional, matrixed environment
- Proactive, solution-oriented communicator with strong attention to detail and problem-solving skills
- Able to work independently, manage time effectively, and troubleshoot technical issues as needed
Benefits
- Competitive pay
- Annual performance bonus
- Generous benefit package with comprehensive Medical/Dental/Vision coverage
- 401(k) plan with employer contribution
- Paid vacation, personal and sick days