Company: Minaris Regenerative Medicine LLC

Job title: Compliance Investigator, Manufacturing

Location: Allendale, NJ

Duties: Determine the causes and preventative actions of Deviations, Non Conformances, OOS, OOT, field complaints and environmental excursion investigations. Drive investigations to true root cause using appropriate investigation tools. Benchmark industry standards to develop, advocate and implement investigative and impact assessment tool sets. Define and implement effective preventative actions to prevent recurrence. Manage multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates. Collaborate with cross functional teams to develop and track Corrective and Preventive Action (“CAPA”) plans. Identify and create appropriate trending rules that trigger corrective actions. Analyze process data and evaluate trends to identify major improvement opportunities. Effectively utilize change management approach. Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process. Champion CAPA plans and implementation. Provide communication plan for ongoing deviations and CAPA’s. Effectively create and communicate CAPA plan to responsible parties. Oversee timely completion of deviations, CAPAs and Change Controls as necessary.

Requirements: Bachelor’s degree or foreign equivalent in Biochemistry, or related field, and 1 year of experience in the position offered or related position in a biotechnology environment, including 1 year of experience with: performing root cause analysis in a pharmaceutical or FDA regulated operation; working in GMP Operations or Quality Assurance in Cell Therapies, Biotechnology or Bio-Pharma; performing deviation investigation and CAPA creation/implementation with all relevant associated documentation; producing and understanding technical/scientific writing within the biotechnology industry; and applying advanced knowledge of Microsoft Word, PowerPoint, Project and Excel.

Send resume to Minaris Regenerative Medicine LLC at rm.minaris.com/en/careers and search by job title.