Bristol-Myers Squibb Company

Quality Control Instrument Technical Support Analyst

Location
Syracuse, NY, US
Posted
Apr 12, 2018
Ref
R1504315
Required Education
Bachelors Degree
Position Type
Full time
POSITION SUMMARY:

The Instrument Technical Support team provides operational and technical support to the QC laboratories by providing lifecycle support for QC analytical instrumentation and equipment. This enables the lab to operate efficiently and ensure capacity for incoming sample volumes.

The QC Instrument Technical Support Analyst is a member of Instrument Technical Support team responsible for supporting the instrument/equipment program in the QC laboratories.

Duties/Responsibilities:
  • Author, execute and review the execution of qualification/validation activities for commissioning of new instrumentation.
  • Initiate and complete instrument related change controls, including execution of pre and post implementation requirements.
  • Author documentation for instrument qualification and computer software/hardware validation protocols and final reports in conjunction with department subject matter experts and quality assurance.
  • Author periodic reviews of computer system validation and instrument qualifications.
  • Ensure that data integrity is being maintained on all instrument systems
  • Maintain comprehensive inventory of instrument and equipment with the laboratory and status
  • Support the calibration program by monitoring calibration schedules, scheduling calibrations and responding to calibration alerts.
  • Lead the completion of instrument deficiencies to ensure timely return to service of existing equipment.
  • Lead and assist with laboratory investigations to determine the impact to product for instrumentation.
  • Maintain instruments in the Computerized Maintenance Management System (CMMS), including preparation and submission of work orders for repair.
  • Support/update instrumentation information in the Laboratory Execution System (LES) and other laboratory systems.
  • Schedule vendors for service, maintenance, or other issues.


QUALIFICATIONS

Specific Knowledge, Skills, Abilities, etc:
  • Working knowledge of laboratory systems much as Empower, NuGenesis and other software programs, including Microsoft Office Applications, preferred.
  • Knowledge base of regulatory requirements for cGMP, computerized analytical systems, i.e. 21 CFR part 11, cGMP, validation, disaster recovery and retirement preferred.
  • Demonstrated problem solving ability, attention to detail, and analytical thinking skills.
  • Interpersonal, oral and written communication skills are essential.
  • Ability to take initiative and prioritize objectives from multiple projects; adhere to scheduled timelines while maintaining flexibility.
  • Ability to work independently with minimal supervision.
  • Contribute to a team based, collaborative and positive environment, clarity of purpose and high commitment to business goals.


Education/Experience/ Licenses/Certifications:

Minimum of BS in relevant scientific or computer area with 1-3 years' experience in the biopharmaceutical industry or equivalent combination of education and experience.

Physical Demands/ Work Environment:

This position is a primarily an office based position, however, requires routine entry into laboratories to access instrumentation which requires appropriate levels of personal protective equipment (PPE). Frequent repeated motions such as lifting, bending, twisting, squatting, walking, climbing on step-stools, and reaching is required. This role also requires frequent unassisted lifting (not to exceed 50 lbs). Office-based work requires sitting. Repetitive use of arms/hands/wrists, especially when working with a computer. This position is based indoors and you will be primarily working with others, however, will also work independently and alone at times. Walking within and between buildings is required to enter laboratories and collaborate with others. This position is a team-based position that may require weekends, holidays, and off shift work.

Travel:

This position does not routinely require travel, however, travel may be required for training/collaboration (

Supervisory Responsibilities:

None