QC Investigator
$90,000–$100,000 year
On-siteOrangeburg, New York, United States
Job Summary
Establish robust investigations for out-of-specification, out-of-trend, and laboratory events within quality control labs, ensuring integrity while adhering to FDA regulations and cGMP standards. Facilitate Phase I and Phase II reports, drive root cause analysis with cross-functional teams, and implement corrective actions for confirmed quality issues. Track investigation closure, monitor Key Performance Indicators, and support regulatory and customer audits. Requires a Bachelor's in chemistry or biological sciences with 3+ years in analytical chemistry and 5+ years in a QC role, plus proficiency in LabWare LIMS and advanced Excel. Salary ranges from $90,000 to $100,000 annually.
Required Qualifications
- Bachelor's degree in chemistry / biological sciences
- Strong knowledge and understanding of good manufacturing practices (cGMPs) for FDA regulated industries, ICH, and other regulations applicable to Good Laboratory Practices (GLP), Good Documentation Practices (GDP), Phase I analytical chemistry laboratory investigations and Phase II manufacturing Investigations
- Knowledge of compendial testing methodologies (USP, Ph. Eu, etc.)
- Knowledge of QC analytical laboratory operations, equipment, software, processes, QC systems, quality improvement tools, and problem-solving techniques
- Laboratory investigation root cause analysis and corrective action
- Proficiency in Microsoft Office Suite, LabWare LIMS, EDMS (Master Control), advanced Excel skills
- 3+ years in an analytical chemistry laboratory environment as a bench chemist with strong technical skills in the pharmaceutical/medical device/or biologics industry
- A minimum of 5 years in a QC role in an NDA, OTC (over the counter) drug or cosmetic manufacturing facility
- Experience conducting of out of specification investigations
- Experience with in root cause analysis
- Knowledge of the FD&C Act, ICH and 21 CFR Parts 210/211 & 11 along with industry required standards for pharmaceutical and OTC drugs
- Superior communication and leadership skills
- Participation in continuous improvement activities in an analytical laboratory environment
- Ability to define problems, collect data, establish facts, and draw valid conclusions
- Ability to analyze data/information and to assess and resolve complex problems in a timely fashion
- Technical writing
- Ability to prioritize commitments and make decisions on best path forward to ensure timely investigation resolution
- Ability to work independently and stay on task in a fast-paced environment without direct supervision
- Ability to function in a rapidly changing environment and balance multiple priorities simultaneously
- Ability to wear personal protective equipment such as gloves, gowning, etc.
- Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored visa sponsorship
Desired Qualifications
- Master's level preferred
- Additional certifications such as CQE, CQA, ASQ-Six sigma green belt or black belt desirable
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