Bristol-Myers Squibb is seeking a highly motivated individual to join a fast paced, cross functional QC chemistry/microbiology team, focused on delivery of STAT results to manufacturing operations.
- Performs routine testing and data review ofin-process, batch release and stability samples of Bulk Drug Substance in a cGMP compliant environment.
- Performs routine assays such as UV-VIS Spectrometry, TOCsr, utility testing, endotoxin testing, and various HPLC methodologies.
- Performs routine environmental monitoring and in-process testing in accordance with SOPs, safety, and cGMP guidelines to support the release and stability of finished products, raw materials, in-process materials, and various components
- Develops working knowledge of cGMP, learn specific job related SOPs and develops proficiency in laboratory techniques
- Writes and revises SOPs for managerial review and approval.
- Aids in troubleshooting equipment and methods.
- Trains less experienced analysts on basic and some more complex test methods.
- Works on a 12 hour (5AM to 5PM)rotating shift which includes every other weekend and some holidays
- Knowledge of science generally attained through studies resulting in a B.S. in chemical or biologicalsciences, a related discipline, or its equivalent is required.
- 0-2 years of experience in a regulated microbiology or chemistry laboratory. Some relevant experience in a biologics QC lab preferred.
- Knowledge of laboratory techniques such as pH, volumetric measurement and basic laboratory safety practices
- Some understanding of regulatory standards
- Excellent manual dexterity including proficiency in aseptic techniques.
- Strong detail orientation with strong general laboratory and good organizational skills.
- Demonstrated ability to work independently as well as part of a team, to complete assignments within defined time constraints.
- Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices.
-Required to work every rotating weekends, some holidays, and during adverse weather conditions in support of manufacturing facility. Flexibility to work irregular hours and short notice overtime.
- QCSTAT Associates will work in teams and have continual interaction with members of his/her team as well as other teams throughout the facility in order to exchange information regarding testing completed, in process and planned.
- Associates should be observant of their work area and related tools and identify and report any discrepancy from normal practice or procedure.
- Associates primarily work in a cGMP laboratory and follow techniques which require one to be alert, giving a high attention to detail, to properly use Personal Protective Equipment (PPE) and to handle hazardous materials Associated topics: equipment, lab technician, laboratory, laboratory support, laboratory technician, quality, quality assurance, research, sample collection, scientific associate
* 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.