Bristol Myers Squibb Lab Systems Lead in Devens, Massachusetts
Support Quality Control data management systems support primarily through use of LES and LIMS. The focus of this role is LES method conversion and maintenance.
Leads activities within Quality Control related to data management systems and the development of processes to maintain these systems. Collaborates with end users to maintain, processes and procedures to govern these systems.
Provides Quality Systems input and support to system owners on the implementation, validation, training, support, and ongoing maintenance of all the QC laboratory data management equipment.
Provides training and troubleshooting for all data management systems
Communicates issues and technical failures to direct supervisor.
Sustains and enhances data management systems as required to support routine testing activities, method transfers and validations and change control activities around these methods or systems.
Applicable methods systems include, but not limited to HPLC, spectroscopy, ELISA, Bioassay and GC methods
Write technical reports, SOPs and perform data analysis and trending for method transfers and process investigations.
Review change controls associated with these applications for impact the QC laboratories.
Represent QC laboratories at site, company and external system meeting.
Work with Automation team regarding Smart Lab program.
Work with CQV team, global IT team, and QC Chemistry and Microbiology teams
Work with automation team regarding technical issues, upgrades and updates to systems as required.
Work with the global IT team, QC Analytical and Microbiology teams.
Occasional contact with other line management staff relating to specific project responsibilities may be expected.
Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, a related discipline, or its equivalent is preferred.
Working knowledge of databases and laboratory applications including LIMS, Smartlab, Sample Manager, Nugensis, and Empower, software desired.
Working knowledge of computer hardware including servers, workstations, network switches, terminal servers, and storage technologies required.
Knowledge of computer software and operating systems including Windows XP, Windows Server 2000, Windows 2003 Server, Oracle, SQL Server.
Knowledge of interfacing of the above applications and impact to each other.
Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices
Significant back room audit experience. Ability to speak to a basic SOP in the front room.
Minimum of 4-6 years of industry experience.
Work in a cGMP laboratory and manufacturing environment following techniques which require one to maintain a high attention to detail, to properly use Personal Protective Equipment (PPE) and to handle hazardous materials.
May work on assignments that are extremely complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations. Exercises judgment within broadly defined practices and policies in selecting methods and techniques and evaluation criteria for obtaining results. Makes sound decisions and applies appropriate notification to management as appropriate. Failure to obtain results or erroneous decisions or recommendations
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.