Bristol Myers Squibb Company

Senior Analyst, QC Micro

Location
Phoenix, AZ, United States
Posted
Sep 09, 2020
Ref
R1525259
Discipline
Quality, Quality Control
Required Education
High School or equivalent
Position Type
Full time
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.

Purpose and Scope of Position
The Senior Analyst, QC Microbiology, is responsible for routine and non-routine microbiological testing and environmental monitoring in support of sterile product manufacturing. The Senior Analyst
is also responsible for peer review, training, supporting document management, projects, CAPAs and ivestigations in accordance with the organization's policies, procedures, and state, federal and local
laws and ensure compliance with current Good Manufacturing Practices (cGMP), USP, EP, JP and other regulatory requirements at all times.

Required Competencies: Knowledge, Skills, and Abilities
• Advanced proficiency in MS Word, Outlook, and Excel programs as well as PowerPoint, Project and Visio.
• Advanced hands on experience with various microbiological testing techniques, environmental monitoring techniques and scientific knowledge.
• Advanced knowledge of how to conduct effective training and coaching of analysts.
• Intermediate ability to make and deliver formal presentations to internal and external audiences.
• Basic knowledge of electronic laboratory management systems.
• Strong attention to detail.
• Basic management and organizational skills.
• Basic team and individual leadership skills.
• Advanced understanding of relevant scientific and technical principles.
• Basic project management skills; capable of participating in departmental teams.
• Advanced knowledge of cGMP, USP, EP, FDA/PDA, OSHA and other regulatory guidance documents as relates to microbiological testing and environmental monitoring.
• Advanced written and verbal communication skills.
• Ability to develop detailed instructions accurately.
• Ability to gown and maintain a sterile work environment.
• Ability to work under limited supervision.
• Advanced GMP documentation skills.
• Advanced knowledge of laboratory safety practices.
• Ability to mentor peers on day-to-day tasks and more technical tasks; cooperative and works well with a team.
• Willingness to learn and share knowledge.
• Communicates effectively with peers, management and cross-functionally across the site.
• Intermediate knowledge of laboratory and aseptic processes.
• Ability to interpret / write complex business and technical documents.
• Advanced critical reasoning and decision-making skills for solving routine and complex problems that impact multiple departments.
• Ability to pass an initial full physical with annual monitoring.
• Ability to deal appropriately with regulatory agencies and act as a Subject Matter Expert (SME) for the department during regulatory and non-regulatory inspections.

Duties and Responsibilities
Performs routine laboratory and EM activities.
• Prepares schedules and sample labels.
• Performs tests such as (but not limited to) bioburden, BET, sterility, Growth Promotion, incoming media/reagent QC, BI testing.
• Operates laboratory equipment used to provide sterile and depyrogenated materials.
• Read EM and testing plates and assess against alert and action levels as appropriate.
• Performs microbial isolation techniques, Gram stains and supports microbial identification process.
• Performs environmental monitoring activities in support of manufacturing.
• Collects utility samples for analysis.
• Maintain qualification status on aseptic gowning, sterility testing, BET, etc.
• Demonstrates aseptic technique when performing a Microbiological Test or EM.
• Perform testing/monitoring activities associated with protocols or special projects as required.

Perform peer review of testing data.
• Review all data in accordance with applicable procedures and cGMP requirements.
• Apply technical knowledge and abilities to ensure all testing is performed in a compliant matter.
• Complete all review in accordance with required timelines.
• Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.

Train new analysts to general job duties and specific testing and monitoring activities.
• Complete necessary training to become a qualified trainer.
• Perform training effectively.
• Document training per procedural and cGMP requirements.
• Determine training schedule and develop training content.
• Participate in hiring and onboarding processes of new analysts.
• Coach other analysts in troubleshooting microbiology methods, EM techniques and scientific equipment.
• Act as a mentor for other analysts, freely sharing knowledge and experience.
• Assists with developing best practices in the laboratory

Support management with day-to-day department activities
• Coordinates testing and monitoring activities within the QC lab and manufacturing facility.
• Ensure proper tracking of non-routine testing events.
• Follow up on testing execution with analysts, ensure communication to Laboratory Management.
• Responsible for tracking tools (EM batch release, sample trackers, etc.)
• Supports lab management in mid to long range capacity planning.
• Administrative tasks.
• Perform approval of laboratory data as required.
• Assist with allocation of resources, such as instrumentation and analyst availability.
• Assist analysts with questions and troubleshooting.
• Communicate effectively with management regarding more complex issues.

Support document revision, project, CAPA and investigation/deviation tasks.
• Perform assigned tasks within a CAPA, deviation or project.
• Participate in more complex projects and continuous improvement efforts.
• Take a leadership role on more complex projects.
• Draft and review technical documents, such as SOPs and protocols.
• Communicate effectively with management regarding task completion, roadblocks and needs.
• Assist in the development and implementation of corrective actions.
• Prepares written QC Microbiology trend reports.
• Determines impact of changes to QC department and supported GxP computerized systems.
Performs general laboratory duties as assigned.

Education and Experience
• High School diploma or equivalent required.
• Bachelor's Degree, particularly in Microbiology or Science related field, preferred.
• 3 years relevant work experience required, preferably in a manufacturing environment with cGMP requirement.
• An equivalent combination of education / experience may substitute.

Working Conditions
• The incumbent will be required to wear uniform/ PPE to work in a manufacturing, warehouse, or laboratory environment.
• The incumbent may be fully gowned for extended periods of time within a restrictive movement environment. This may include standing, bending, reaching, kneeling, etc.
• The incumbent will have to perform work in a controlled environment with strict glove and gown rquirements.
• The incumbent will be required to maintain a safety alertness due to work around hazardous equipment and cytotoxic product.
• This position requires regular medical surveillance and may require incumbent to wear a respirator or gown.
• The incumbent must be able to distinguish colors and possess correctable vision to 20/20; annual eye exam is required.
• The incumbent may analyze data and work with spreadsheets and graphs on a daily basis.
• The incumbent may be working in a laboratory or manufacturing setting up to 6 hours per day.
• The incumbent must be able to lift/carry NMT 25 lbs.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe
those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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 the resources to pursue their goals, both at work and in their personal lives.