Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market. JOB SUMMARY This position is primarily responsible for management and completion of site investigations. This position is an individual contributor role that works cross-functionally to collect information used to assess impact, identify root cause, and mitigate recurrence through CAPAs. This position requires attention to detail, organization, multi-tasking, and comfort interacting cross-functionally with people who might be junior or senior to the incumbent. The successful candidate is able to work under the appropriate amount of direction based on level and possesses the ability to work on complex problems by analyzing procedures and data to create solutions. ESSENTIAL DUTIES AND RESPONSIBILITIES Owns, leads, authors, and drives site investigations to closure. Participates in or leads deviation related meetings, including: Cross-functional Triage meetings to gather facts/data upon event discovery Investigation planning meetings to aligning internal review team and area subject matter experts on an agreed upon investigational path forward Deviation and CAPA Review Board meetings to update leadership on current status of investigations Specialist may lead triage meetings and Deviation Review Board. Identifies Root Cause by utilizing common and advanced root cause analysis tools such as Control Charts, Fishbone Diagrams, 6Ms and 5 Whys. Authors Minor, Major and Critical investigation reports by utilizing robust technical writing skills to communicate moderate to complex technical issues. Serves as liaison between multiple teams including Manufacturing, MSAT, Engineering, Quality Control, Supply Chain and Quality Assurance to conduct and complete thorough deviation investigations. Ensures appropriate CAPAs are defined to address the identified root cause, and suitable Effectiveness Checks are put into place to proactively ensure the effectiveness of the CAPA. Monitors assigned deviations to ensure on time closure. Maintains SOPs and other GMP documents as needed to support the program. Participates in the Quality Risk Management program when requested. May support regulatory inspections as a Subject Matter Expert (SME) for Deviations. Acts as a mentor to peers for Root Cause analysis and Investigation writing. This position is a delegate for other Investigation Specialists. Specialist may be a delegate for the Manager, Investigations. KNOWLEDGE, SKILLS, AND ABILITIES To perform this job successfully, an individual should be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required: Strong knowledge of cGMP regulations and the ability to apply them to commercial manufacturing. Knowledge and understanding of Root Cause Analysis processes in a regulated environment. Skill in effective verbal and written communications. Ability to respond quickly to complex inquiries from customers, co-workers, and supervisors regarding deviation details. Demonstrated conflict resolution skills in a cross-functional setting with the ability to keep objectives on track. Proven technical writing skills within a cGMP manufacturing environment are required. Formal Technical Writing certification is strongly preferred. Knowledge of and skill in using computer software and hardware applications. Proficiency with Microsoft applications, including MS Word, MS Excel and Teams (required), and with eQMS applications such as TrackWise (preferred). Demonstrated ability to work collaboratively to accomplish deadlines and objectives. Demonstrated ability to work in a fast-paced environment, with the ability to manage multiple projects and objectives for on-time event closure. Ability to be proactive, detail-oriented, and adapt to changing priorities. Biotech industry experience strongly preferred EDUCATION and/or EXPERIENCE BS in scientific discipline such as Bioprocess Engineering, Biochemistry, Chemistry, Biology or related discipline Experience with quality management system (MasterControl, TrackWise, etc.) software preferred Experience interacting with clients in a Contract Development and Manufacturing Organization (CDMO) preferred Years of Experience Requirements Senior Specialist: Minimum 8 years’ experience in quality management systems, conducting investigations and/or root cause analysis working in a regulated or cGMP environment preferred Equivalent education and experience may substitute for stated requirements Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook! AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances. AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.