Bristol-Myers Squibb Company

Associate, QC Operations

Location
Devens, MA, United States
Posted
May 18, 2019
Ref
R1515662
Required Education
Bachelors Degree
Position Type
Full time
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.

Responsibilities:

- 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

- Performs sample management including: sample receipt, sample tracking, aliquots preparation, and sample distribution.

- 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

Qualifications

- 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