Bristol-Myers Squibb Company

QC Trending Specialist, QC Technical Support

Location
Devens, MA, US
Posted
Oct 04, 2018
Ref
R1509290
Required Education
Bachelors Degree
Position Type
Full time
Reporting to the QCTS QC Services Manager, the QC Trending Specialist will be responsible for activities associated with method trending and monitoring for the Devens Method Performance Monitoring Program. He/she will execute collection, compilation, and administration of method performance and release data generated at the Devens QC laboratory. The QC Trending Specialist will participate in monitoring and analyzing data using statistical tools to monitor QC method performance and manufacturing processes. He/she will perform timely data collection and data mining to support data analysis requests for trend reports, investigations, and analytical method changes. Additionally, the QC Trending Specialist may support optimization and deployment of new tools for analytical method performance data trending.

MAJOR DUTIES AND RESONSIBILITIES:
  • Execute collection, compilation, and administration of method performance and release data generated at the Devens QC laboratory.
  • Participate in monitoring and analyzing performance of analytical methods and release data using statistical tools to monitor QC method performance and manufacturing processes.
  • Perform timely data collection/data mining to support data analysis requests for APR/APQR, investigations, and analytical method changes.
  • Support publishing routine and ad-hoc trend reports.
  • Support optimization and deployment of new tools for analytical method performance data trending.
  • May participate in audit response development and CAPA identification.
  • Other duties as may be assigned.


KNOWLEDGE AND SKILL:
  • Knowledge of science generally attained through studies resulting in a B.S. in biological sciences, chemistry, and/or statistics or related discipline is preferred.
  • A minimum of 1-3 years relevant experience in a regulated environment.
  • Familiarity with US and EU cGMP regulations and guidance.
  • Experience in trending/statistical analysis of biological analytical method data.
  • Working knowledge of databases and laboratory applications including SampleManager LIMS, Biovia LES/ELN, NuGenesis, and Waters Empower software highly preferred.
  • Knowledge of Trackwise and statistical software platforms such as Discoverant and JMP desired.
  • Working knowledge of common computer systems such as MS-Word and Excel is required.
  • Organized with strong attention to detail and time management skills.
  • Strong oral and written communication skills. Ability to effectively interact with teams within BMS site.


CONTACTS:

Incumbents have daily interaction with their supervisor and other members of the QCTS and QC organizations. This role may have the occasional business need to interact with any employee at any level of the Devens Facility, including occasional contact with outside vendors and contact with representatives from health authorities / regulatory agencies during site audits.

WORKING CONDITIONS:

Work is largely performed in a modern office and a cGMP laboratory / manufacturing facility where one must maintain a high attention to detail and to be aware of the presence of workplace hazards including pressurized liquids gases, steam, biohazards and hazardous chemicals. The use of Personal Protective Equipment (PPE) will be required in the laboratories and in some portions of the facility.

DECISION MAKING:

Incumbents normally receive general instructions on routine work and specific instructions on new assignments. When problems are identified works with Management to resolve.

SUPERVISION RECEIVED:

Receives assignments which require the application of a defined process to complete the assignment with some variability in application depending on potential impact / scope of the assignment. As such specific assignments are allocated based upon the recipient's demonstrated capabilities with the degree of supervisory attention determined accordingly.

SUPERVISION:

No direct supervision, but the Specialist will be expected to participate in the training of less experienced staff in normal operational tasks.

Travel Required: Up to 5%