QA Compliance Specialist

Job Title QA Compliance Investigator Job Description Join a dynamic team dedicated to improving processes and ensuring compliance in a growing organization. As an Investigator, you will be responsible for writing and completing investigations and deviations, ensuring compliance from both a compliance and operations perspective. You will conduct root cause analyses and manage the full lifecycle of investigations, from opening to closing, independently. Responsibilities Write and complete investigations and deviations ensuring compliance with manufacturing and GMP standards. Conduct root cause analysis and own the entire lifecycle of investigations. Interview manufacturing personnel and communicate with vendors regarding investigations. Determine causes and preventive actions for deviations, non-conformances, OOS, OOT, field complaints, and environmental excursions. Drive investigations to true root cause using appropriate tools and benchmark industry standards. Define and implement effective preventive actions to prevent recurrence. Manage multiple investigations to meet compliance deadlines and product release dates. Collaborate with cross-functional teams to develop and track CAPA plans. Identify and create appropriate trending rules to trigger corrective actions. Analyze process data and evaluate trends to identify improvement opportunities. Utilize change management approaches effectively. Develop training materials to train personnel on writing problem statements and using root cause analysis tools. Champion CAPA plans and their implementation. Provide communication plans for ongoing deviations and CAPAs. Oversee timely completion of deviations, CAPAs, and change controls. Essential Skills 2-3 years of experience writing and reviewing deviations and investigations. Experience within a pharmaceutical company supporting manufacturing. Previous experience in a quality assurance team. Experience with CAPA, GMP, and biopharma/biotech environments. Proficiency in technical writing and root cause analysis. Ability to own and author deviations. Additional Skills & Qualifications Bachelor's degree in a related scientific field. Experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology, or Bio-Pharma. Preferred experience in pharmaceutical or FDA regulated operations. Experience using e-Quality Management Systems preferred. Proficiency in IT skills such as Visio, Microsoft Project, and Excel. Work Environment Work closely with a team of QA/QC professionals and collaborate cross-functionally with the manufacturing team. The team currently consists of 2-3 other investigators. Role involves working at two sites that are a block away from each other. First shift, Monday through Friday, with a start time of 8am or 9am. The company offers a supportive work culture focused on growth and expansion, with the mission of saving patients' lives. Job Type & Location Contract to Hire position based out of Allendale, NJ. Pay and Benefits Pay range: $45.00-$45.00 per hour. Benefits may include: Medical, dental & vision Critical illness, accident, and hospital coverage 401(k) retirement plan - pre-tax and Roth post-tax contributions available Life insurance (voluntary life & AD&D for the employee and dependents) Short and long-term disability Health spending account (HSA) Transportation benefits Employee assistance program Time off or leave (PTO, vacation, or sick leave) Workplace Type Fully onsite position in Allendale, NJ. Application Deadline Position anticipated to close on July 13, 2026. Equal Opportunity Employment The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. #J-18808-Ljbffr Actalent