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QC Laboratory Equipment Specialist (cGMP – Pharmaceutical) JD818754

JD818754

DPS is seeking an established and knowledgeable QC lab professional to work with a BioPharma client in the Boston, MA area. Primary responsibility will be to manage the operations and maintenance of QC equipment.

Category:
Control Quality
Location:
Massachusetts
Years of Experience Req.:
5+
Date Posted:
31/05/2019
Days Remaining:
29
Employment Type:
Full-time
Education Level Req.:
Bachelors

QC Laboratory Equipment Specialist (cGMP – Pharmaceutical)  JD818754

Boston, MA area

 

DPS is seeking an established and knowledgeable QC lab professional to work with a BioPharma client in the Boston, MA area.  Primary responsibility will be to manage the operations and maintenance of QC equipment. 

 

Responsibilities:

  • Manage the Empower Enterprise System which includes administrative functions and working with the vendor on troubleshooting.
  • Analytical equipment management including scheduling all routine and non-routine maintenance.
  • Work closely with vendors on service contracts setup and management and on troubleshooting software and hardware related issues.
  • Work closely with the Facilities/Engineering group for work orders and assets in the lab.
  • Work closely with the QA, Validation and IT for the setup of equipment and the associated software IQ/OQ and validation activities.
  • Write and manage all equipment related CAPAs and change controls in QC.

 

Qualifications & Experience:

  • Bachelor’s Degree in Biochemistry, Science or related technical field.
  • Minimum 5+ years of experience analytical equipment and software management.
  • Strong technical knowledge of analytical equipment such as HPLCs with ELSD, UV, Fluorescence, and RI detectors, UV/Vis spectrophotometers, Malvern Particle siz355741.242289e, TOC analyz355741.242289er, and other standard wet chemistry equipment.
  • In-Depth knowledge of the Empower Enterprise software.
  • Demonstrated knowledge of current regulations, guidance, and compendia.
  • Reliable and motivated with a desire to work collaboratively across teams and departments such as Quality Assurance, Validation and IT.
  • Ability to work independently with minimal oversight and to act as a leader in the QC laboratory.
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