Quality Control Scientist- Microbiology

Profile

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In 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.

POSITION SUMMARY

This position will work both independently and with the team to perform routine and non-routine Environmental Monitoring functions and support of Microbiology labs with microbiological testing and microbiology laboratory maintenance functions. Current shift schedule is either Sunday-Wednesday or Wednesday-Saturday, 4 ten-hour days. Days and hours may change based on business needs.

PRIMARY DUTIES/RESPONSIBILITIES


Carry out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements at all times.
Follow directions properly, work cooperatively as an individual contributor and as a team member.
Communicate effectively with QC peers, cross-functional peers and management.
Assist in troubleshooting and solving problems that may come up in the day to day operation of the department.
Participate in aseptic process qualifications, such as aseptic gowning and media fills.
Perform Sterility Testing and sample aliquoting.
Perform microbial identification via polymerase chain reaction (PCR).
Perform Viable and Non-Viable air monitoring viable surface monitoring.
Perform and lead Environmental Monitoring Performance Qualification and Aseptic Qualifications.
Perform Environmental Monitoring on routine basis.
Perform microbial isolation techniques and perform Gram stain identifications.
Send out samples to contract labs and track results/reports.
Evaluate environmental/personnel monitoring samples and create NOEs for action levels.
Performs general laboratory cleaning/wipe-down.
Perform routine maintenance of lab equipment.
Under the guidance of management, support special project work.
Document laboratory test results on worksheets, forms and logbooks utilizing Good Documentation Practices.
Maintain lab inventory and order lab supplies and materials.
Receives and stock test reagents, lab supplies and test media.
Support continuous improvement projects related to QC
Author and revise controlled documents such as Standard Operating Procedures and Controlled Forms. Author non-routine Protocols/Validation Plans/ reports in support of projects.
Assist with investigations &CAPAs associated with Microbiological testing.
Support data trending and tracking of results.
Fosters teamwork and promotes an environment that motivates others to achieve goals.
Perform all other duties as assigned.


EDUCATION/EXPERIENCE REQUIREMENTS


Requires Bachelor's degree in Microbiology, Molecular Biology, or related discipline; Master's Degree strongly preferred.
A minimum 5 years of experience working in a GMP regulated manufacturing environment withEnvironmental Monitoring and Microbiology lab experience required.
An equivalent combination of experience/education is acceptable.
Have a good understanding of USP, EP, JP, and FDA microbiology testing requirements.
Good knowledge of Microsoft Word and Excel.
Responds to challenges and additional projects in an understanding, positive, and objective manner.
Adaptable to dynamic conditions, work practices, and project timelines.
Ability to multitask, prioritize workload and interpret data accurately.
Able to communicate effectively with GDPO functional areas and external agencies.


Working Conditions


The incumbent will be required to wear uniform/ PPE to work in the manufacturing or laboratory environment.
The incumbent may be required to stand and walk for extended amount of time.
The incumbent may be required to work hazardous materials and areas with magnetic and electric fields.
Flexibility with schedule (weekends, holidays, extended hours and rotating/staggered shift) is an absolute must.
Change to work timings and assigned tasks may occur at a very short notice to support business needs.
Shift schedule could include 4 days including weekends.


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.

Company: Bristol-Myers Squibb

Req Number: R1527873_EN

Updated: 2020-07-23 00:00:00.000 UTC

Location: Summit,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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