Contract Research Associate

Key Responsibilities: Oversee and execute complex and critical deviations and investigations related to quality and manufacturing. Facilitate the generation of clear, concise, and thorough investigation reports. Support quality and manufacturing investigations resulting from Out of Specification Results (OOSs) Phase II. Investigate in-process and finished good non-conformances (NONCs) to identify root causes. Conduct root cause analysis and provide quality, compliance, and technical feedback. Assist with Corrective Action Preventive Action (CAPA) reports. Support coordination and investigations resulting from critical and adverse customer complaints. Ensure timely approval and compliance of investigation documentation. Track, monitor, and close quality and manufacturing investigations. Participate in audits, customer interactions, and regulatory inspections. Qualifications: Bachelor's degree in a scientific discipline. 3-5 years of experience in the Pharma or Medical Device industry with an emphasis on quality. Working knowledge of QSR, ISO 9001:2000, ISO 13485:2003, and cGMP's. Proficiency in Microsoft Office Suite, SharePoint, LIMS, Master Control; advanced Excel skills. Excellent organizational, interpersonal, analytical, and problem-solving skills. Strong writing and leadership skills. EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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