Senior Specialist, QC Equipment Qualification
Expiry Date :
Tue, 15 Jun 2021 23:59:59 GMT
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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. Job Summary Bristol Myers Squibb is seeking a Senior Specialist, QC Equipment Qualification and lifecycle management, at Cell Therapy Facility (CTF) in Devens, MA. The QC Sr. Specialist Equipment Qualification is responsible for qualification, calibration and maintenance of Quality Control equipment in support of analytical and microbiology QC laboratories. This includes, but is not limited to, interfacing with QC method SMEs, Site Engineers, Facilities, and vendors to facilitate and leading in equipment lifecycle management, including qualification, calibration, maintenance and decommission activities. The Sr. Specialist role is stationed in Devens, MA and reports to the Associate Director of CTF QC Systems. Job Responsibilities: Serves as the QC equipment system owner and manages the lifecyle activities of QC laboratory equipment, including: – Support creation of equipment User Requirement, IOPQ protocols. – Collaborating with QC laboratories, Site Engineering, Facility Services and other departments for the commissioning and decommissioning of laboratory equipment. – Schedule, facilitate and participate in performing the qualification, calibration, maintenance, repairs of QC laboratory equipment, whether performed internally or by vendors. – Maintain equipment records in accordance with GMP requirements and written procedures. – Maintain electronic equipment database, equipment logs, equipment status metrics, and applying equipment status labels. – Providing basic and first-line equipment troubleshooting. – Providing training to laboratory personnel on equipment calibration and maintenance processes, as applicable. – Overseeing QC activities related to equipment change management. – Assisting management with investigations and deviations related to equipment. – Performs other tasks as required to support the QC laboratories. Qualifications and Education Requirements – Advanced competency and experience in QC instrument qualification in GMP environment. – Working knowledge of Biomolecular, Analytical and Microbiology laboratory equipment such as Flow Cytometry, PCR, BSCs, BACTEC, Plate reader, etc. and ability to perform basic equipment troubleshooting is desirable. – Knowledge of analytical and microbiological test methods and environmental monitoring programs is desirable. – Knowledge of GMP regulations and Ability to accurately and completely understand, follow, interpret, and apply global regulatory and GMP requirements. – Detail-oriented with expertise in problem solving and solid decision-making abilities. – Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects. Ability to work with management locally and globally. – Strong written and verbal communications skills and interpersonal skills; Advanced ability to communicate effectively with peers, department management and cross-functional peers – Working knowledge of Data Integrity is desired. – Bachelors degree required, preferably in chemistry, microbiology, or related science. – 6 + years of relevant experience, preferably in a regulated environment. – Experience with current Good Manufacturing Practices (cGMPs) and 21 CFR 210/211. – Experience and understanding of biological manufacturing processes and aseptic technique a plus. – An equivalent combination of education and experience may substitute. If you want to challenge yourself, accelerate your career, and give new hope to patients, theres no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today. BMS CART 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. 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. Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.