QC Specialist, Microbiology

  • Anywhere

Company :
Bristol-Myers Squibb

Location :
Bothell, Washington

Expiry Date :
Mon, 14 Dec 2020 23:59:59 GMT

Apply Job :
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Description :
At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results. General Summary: The QC Specialist, Microbiology is a full-time position that plays a key role in supporting the objectives of the contamination control strategy at the Juno Manufacturing Plant (JuMP) located in Bothell, WA. The primary focus for this role is the maintenance and continuing improvement of business processes specific to the JuMP Environmental Monitoring (EM) and site contamination control programs. This includes EM risk assessment, trending and interpretation of EM data, and oversight of the EM excursion business process. The QC Specialist owns or supports investigation and/or change control strategies for processes that impact environmental control. Additionally, this role works closely with stakeholders in manufacturing, engineering, and validation to drive alignment to site contamination control goals and standards. The QC Specialist, Microbiology is a Subject Matter Expert for compendial and rapid microbiology laboratory methods, and serves as the technical lead for evaluation, validation, and implementation of new microbiology methods. Minimum Requirements Education: Bachelors degree, preferably in biology, microbiology, or biochemistry Experience Five years experience in a cGMP/FDA-regulated environment Experience with application of root cause analysis tools for the purpose of investigation execution Experience and extensive understanding of environmental control regulations and guidelines with in-depth knowledge of cGMPs Proven experience working as a detailed-oriented team player with effective planning, organization and execution skills Strong computer skills with MS Office (e.g. Word, Visio and Excel) Ability to work effectively at a fast pace with cross functional departments to finalize time-sensitive deliverables Innovative, proactive, and resourceful; committed to quality and continuous improvement Experience with Quality Systems (e.g. Document Management System, Quality Management System, Learning Management System, Change Control, Deviations, and CAPA programs) Essential Duties – Oversight of the EM excursion business process, and metrics relating to the health of the process – Execute and continually improve the EM trend program – Compile and evaluate EM data for specific initiatives related to the strengthening of the JuMP contamination control strategy – In addition to interpretation of EM data, provide technical expertise for interpretation of data in support of root cause analysis and continuous improvement of processes such as cleaning, gowning, and facility flow. – Proficient in Microsoft Office programs, with advanced/expert proficiency in MS Excel. – Good interpersonal skills and ability to work with others in a positive, collaborative manner. – Ability to work independently and perform with a high degree of accuracy. – Ability to learn and apply Federal (FDA) Good Manufacturing Practice (GMP) requirements and guidelines and documentation practices. – Experience in GMP-regulated environment is preferred, working knowledge of Good Manufacturing Practices (21 CFR 210/211, 600, & 820). BMSCART Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.