QC STAT Associate (AM Shift) (Fitchburg)
Employment Type: Full-Time
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.
Bristol-Myers Squibb is seeking a quality control professional to join our QC STAT team, performing QC testing in support of biologics bulk drug substance manufacturing using defined methods in a cGMP compliant laboratory. The QC Associate assures test results are accurately recorded and abnormal data or equipment/instrument malfunctions are promptly reported to his/her supervisor. The QC STAT AM team works a 12-hour shift (5AM to 5PM) with rotating work days across a 2-week period (36/48).
- Performs routine testing and data review of in-process and batch release samples of Bulk Drug Substance in a cGMP compliant environment.
- Performs routine assays such as UV-VIS Spectrometry, Titer, utility testing, personnel and environmental monitoring, Total Organic Carbon testing, and more complex assays including various HPLC methodologies (e.g., sialic acid).
- Performs broad range of troubleshooting techniques and leads such within area of expertise.
- May write and revise SOPs for managerial review and approval.
- May train less experienced analysts on basic and some more complex test methods.
- Knowledge of science generally attained through studies resulting in a BS degree, preferably in Chemistry, Molecular Biology, or related discipline.
- A minimum of 0-2 years of experience in a Biologics QC laboratory or related biopharmaceutical cGLP or cGMP lab.
- Experience in analytical test methods such as UV/Vis, HPLC, TOC, and protein purification highly preferred.
- Knowledge of lab software applications (e.g., LIMS, ELN (LES/SmartLab), Empower) preferred.
- Excellent manual dexterity including proficiency in aseptic techniques desired.
- High attention to detail 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 problem solving and analytical thinking skills.
- QC 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.
- All QC Associates will have daily contact with her/his supervisory staff for work assignments, coaching and general management discussions. Incumbents normally receive general instructions on routine work and specific instructions on new assignments.
- Occasional contact with other line management staff relating to specific project responsibilities may be expected.
- QC Associates primarily work in a cGMP laboratory and follow techniques which require one to be alert, giving a high attention to detail, and to properly use Personal Protective Equipment (PPE) when handling hazardous materials.
- Work will be required on weekdays, weekends, holidays, and during adverse weather conditions in support of manufacturing facility. This is a 12-hour (5am-5pm) rotating shift. Occasional overtime work may be required.
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.
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