Vacancy expired!
Piper Clinical Solutions is actively seeking a QA Investigations and Deviations Specialist to work for a large global biotechnology company focused in cell therapy in the greater Newark NJ area. This position is hybrid work from home / remote and onsite. Candidates expected to be onsite 2-3 days per week.
Responsibilities for Quality Assurance (QA) Specialist: • Assess deviations for manufacturing, analytical labs, environmental monitoring and manufacturing sciences and technology to classify critical level • Conduct investigations, develop root cause analysis, and create CAPAs as needed • Responsible for writing, reviewing and revising investigation reports, CAPAs, and present findings to the leadership team • Ensure timely close out of all investigations, assist with root cause analyses, oversee change controls, and write up corrective action and preventative actions (CAPAs). Technical Requirements for Quality Assurance (QA) Specialist: • Bachelor's degree in biology, chemical engineering, biochemistry, or related field. • Minimum 5 years of experience working in a pharmaceutical or biotechnology GMP regulated environment. • At least 3 years of experience with conducting investigations and determining root cause analysis in manufacturing, analytical labs, warehouse, environmental monitoring, and/or engineering • Excellent organizational skills and proven experience working in a fast-paced environment. Compensation & Benefits for Quality Assurance (QA) Specialist: • Compensation: $65,000-115,000 based on previous salary history and experience • Full Benefits: Medical, Dental, Vision, PTO, etcVacancy expired!