Bristol Myers Squibb QC Microbiology Specialist Post Vacancy
Molecular biology and Microbiology job vacancy at Bristol Myers Squibb. Bristol Myers Squibb is 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.
Job Title: Specialist, Associate Scientist, QC Microbiology (Quality Control)
Location: Summit, New Jersey
Job Id: R1545475
Eligibility Criteria & Skills:
- Fosters teamwork and promotes an environment that motivates others to achieve our goals.
- Requires Bachelor’s degree in Microbiology, Molecular Biology, or related discipline and minimum 3 years of experience working in a regulated manufacturing environment.
- Environmental Monitoring and Microbiology lab experience strongly preferred. 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 workload in an understanding, professional and objective manner.
- Adaptable to dynamic conditions, work practices, project timelines, and changing schedules.
- Ability to multitask, prioritize workload, document properly, and interpret data accurately.
- Able to communicate effectively with GDPO functional areas and external agencies.
- Flexible and willing to do all assigned tasks with a positive attitude.
- Primary responsibilities will be Environmental Monitoring related tasks.
Working Conditions
The incumbent will be required to wear uniform/ PPE for long durations in the manufacturing or laboratory environment.
- The incumbent may be required to stand and walk for an 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 shifts) is an absolute must.
- Change to work timings and assigned tasks may occur at very short notice to support business needs.
- Shift days and hours may change to accommodate the business needs.
Primary Duties & Responsibilties:
- 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 Validations/ Media Fills.
- Perform Sterility Testing and sample aliquoting.
- 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 identification via polymerase chain reaction (PCR).
- Perform microbial isolation techniques and perform gram stains.
- Send out samples to contract labs and track results/reports.
- Evaluate environmental/personnel monitoring samples and create NOEs for action levels.
- Support Endotoxin and Mycoplasma assays as needed.
- Performs general laboratory cleaning/wipe-down.
- Perform routine maintenance of lab equipment.
- Maintain lab inventory and order lab supplies and materials.
- Receives and stock test reagents, lab supplies and test media.
- Document laboratory test results on worksheets, forms, and logbooks utilizing Good Documentation Practices.
- Support continuous improvement projects related to QC.
- Assist in special projects as needed.
- 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 in investigations &CAPAs associated with QC Microbiology Department.
- Support data trending and tracking of results.
- Perform all other duties as assigned by Management.
Bristol Myers Squibb QC
