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QC SPECIALIST

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb.
Around the world, we are passionate about making an impact on the lives of patients with serious disease.
Empowered to apply our individual talents and ideas so that we can learn and grow together.
And driven to make a difference, from innovative research to hands-on community support.
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.
Our Mammalian center of excellence, Devens announced expansion plans to introduce biologics development and clinical trial manufacturing capabilities to the site, adding approximately 350 employees over time in state-of-the art development and production facilities.
We have an opening for a QC Specialist to work the first shift from Wednesday-Saturday! Responsibilities:
Performs routine testing and data review of raw materials samples and, in-process, batch release and stability samples of Bulk Drug Substance in a cGMP compliant environment.
Performs routine assays such as UV-VIS Spectrometry, SDS Page, Wet chemical analysis, utility testing, various HPLC methodologies (e.
g.
peptide map and carbohydrate analysis,), iCIEF.
Writes and revises SOPs for managerial review and approval.
Performs broad range of troubleshooting techniques and leads such within area of expertise.
Trains less experienced analysts on basic and some more complex test methods.
Qualifications Knowledge of science generally attained through studies resulting in a B.
S.
in chemical sciences, a related discipline, or its equivalent is required.
A minimum of 4 years experience in Biologics QC laboratory or related biopharmaceutical cGLP or cGMP lab.
Experience in analytical test methods such as Peptide Mapping, Carbohydrate Analysis, HPLC, ELISA, iCIEF.
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.
Demonstrates leadership, problem solving and analytical thinking skills.
Specialists 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.
Overtime work may be required on weekdays, weekends, holidays, and during adverse weather conditions in support of manufacturing facility.
Flexibility to work irregular hours and short notice overtime.
Specialists should be observant of their work area and related tools and identify and report any discrepancy from normal practice or procedure, recommending corrective action.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1501616

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