Quality Assurance Specialist + Manage QMS documentation and quality records. + Review quality records and perform batch record review for final release of product. + Identify essential documentation concerns, discrepancies, or compliance issues. + Process documents within electronic quality management systems and act as eQMS administrator. + Assist with and ensure completion of Nonconformance and Planned Deviations. + Participate in the Corrective and Preventative (CAPA) process, including investigations, root cause analysis, and action plan assignment. Track and monitor CAPA investigations, CAPA plans, implementation, and surveillance. + Coordinate the execution of the Calibrated Equipment Program. Perform product complaint entries, product complaint investigations, product complaint close-out reports, and participate in product complaint review calls with customers. + Assist in analyzing company data, including customer complaints and non-conformance reports (NCRs), for patterns or trends; identify potential problems before they occur. + Maintain the data collection and reporting of specified quality metrics and key process indicators; assist with data review and preparation for management review. Prepare and assist with company audits by outside organizations. + Manage training documentation. EXPERIENCE NEEDED + BS in Scientific discipline + 2-3+ years experience in Medical Device or Pharmaceutical QA + Batch record review + CAPA + Product design regulations + Customer complaint review + Knowledge of FDA regulations + QMS certification Job Type This is a Contract-to-Hire position with a duration of 12 Month(s). Work Site This is a fully on-site position in Easton, Pennsylvania. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people 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. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.