Great opportunity to get your foot in the door with one of the top Medical Device companies in the greater North Billerica, MA area! If interested, please reach out directly to Lindsee Allienello at lallienello @ actalentservices.com. Description: + 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 company's 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 4-6 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. + 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. 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.