Associate Scientist, Quality Control Microbiology Environmental Monito (Hoboken)
Compensation: $108,200.00 - $166,760.00 /year *
Employment Type: Full-Time
Industry: Scientific Research
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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.POSITION SUMMARY
This position will work both independently and with the team to perform routine and non-routine Environmental Monitoring, and functions where necessary microbiological testing, microbiology laboratory maintenance functions.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.
- Foster a positive team environment.
- Communicate effectively with direct manager, 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 fill reads.
- Perform Environmental Monitoring on routine basis.
- Perform microbial identification via polymerase chain reaction (PCR).
- Perform growth promotion testing of microbiological media.
- 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.
- Support Bacterial Endotoxin and Sterility Testing.
- Support mycoplasma testing via PCR.
- 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.
- Perform all other duties as assigned.
- Requires Bachelor's degree in Microbiology, Molecular Biology, or related discipline and a minimum 3 years of related Environmental Monitoring experience working in a regulated manufacturing environment.
- Environmental Monitoring Microbiology lab experience & Master's Degree 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 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.
- Fosters teamwork and promotes an environment that motivates others to achieve our goals.
- The incumbent will be required to wear uniform/ PPE to work in the manufacturing or
- The incumbent may be required to stand and walk for extended amount of time.
- The incumbent may be required to work with hazardous materials and be exposed to areas with magnetic and electric fields.
- Flexibility with work schedule (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.
- This position's 4 day Shift schedule, can be either Sunday - Wednesday or Wednesday-Saturday, 7:00AM-5:30PM or 8:30AM-7:00PM.
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.
Associated topics: bacteria, clinical, food, histology, immunology, patient, pharmacology, transfection, trauma, vaccine
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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