Quality Engineer

Quality Engineer who, under minimal supervision, provides Quality oversight activities for the aseptic fill/finish manufacturing suite and Quality Assurance technical expertise to ensure aseptic manufacturing facility, processes, and support systems are compliant with company guidelines and CGMP regulations marketed products and/or their raw materials, APIs, excipients or components. 100% Onsite in Billerica, 5 days a week. Must Haves: 2 years exp with fill finish, quality events, capa, change controls, on the floor batch records, aseptic exp. Key Responsibilities/Essential Functions Provide technical expertise in conducting investigations and making recommendations for targeted data and information collection as required for quality events. Collaborate with cross-functional production support teams to identify root cause and determine appropriate corrective action/preventative actions for investigations. Resolve unique and/or adverse situations, gather and review information from diverse functional areas, and make appropriate quality recommendations based on evidence. Review and approve protocols, validation documents, investigations and procedures. Approve change controls and represent Quality in Change Control Board meetings as needed. Provide Quality on the floor presence in support of manufacturing operations. Represent QA in a range of internal team meetings, processes and initiatives. Alert management of critical issues that have significant impact to manufacturing objectives and timelines, while providing a range of achievable solutions. Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards. Actively demonstrates the values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork. In the case of absence, reports to Manager above or a peer incumbent will function as a backup for this position. Basic Qualifications BS/BA degree in a scientific discipline with 2 years of progressive experience in the pharmaceutical or radiopharmaceutical industry or related GMP environment, or equivalent. This position is site-based and requires a presence on-site five days per week. Other Requirements Aseptic fill-finish experience, including familiarity with validation of aseptic manufacturing technologies and facilities is preferred. Routinely scheduled work, and/or work required on evenings, weekends, and or holidays and, even in adverse weather conditions to support manufacturing operations. See Essential Personnel Policy. Handling of and, or exposure to potentially hazardous chemical, radiological and or biological materials. Required to follow all safety procedures and use personal and protective equipment provided. Ability to travel up to 10% domestically. Work Schedule is Monday - Friday 10-6pm