Job Openings

OVERALL SUMMARY OF POSITION:

Manage, maintain and enhance GLP compliance within Bioanalytical Development. Work on problems of diverse scope where the analysis of data or information requires evaluation of identifiable factors. Exercise judgment within generally defined practices and policies in selecting methods, techniques for obtaining solutions.  Normally receive no instructions on routine work and general instructions on new assignments.  Work on assignments that are often highly complex in nature where judgment is required in resolving problems and making routine recommendations.

ESSENTIAL DUTIES:

v  Perform and ensure the completion of routine and scheduled preventative maintenance, calibration, monitoring and cleaning of all GLP equipment and instruments

v  Perform internal audit on raw and processed data in assay packages and notebooks

v  Manage and maintain GLP systems including pipette and instrument calibration records, freezer and refrigerator inventories, network folder maintenance, temperature charts, etc.

v  Manage GLP documentation involving processes, deviations, CAPAs, calibration, and planned changes

v  Manage archival of GLP documents in hardcopies and electronic files

v  Evaluate, revise and submit documents and document changes pertaining to compliance requirements for approval (SOPs, bioanalytical reports, validation reports, deviation reports, etc.)

v  Evaluate compliance of completed documents (SOPs, bioanalytical reports, etc.)

v  Interact with Quality and Facility Engineering to continually improve compliance with GLP systems, SOPs, and regulatory requirements and to resolve minor and major deviations

v  Participate as required to investigate and resolve quality and compliance issues

v  Participate in GLP compliance audits by Quality department and external auditors

v  Participate in compliance audits of vendors and support functions as required

v  Coordinate, organize and conduct GLP training for the group

v  Manage lab supply inventory and procurement

v  Maintain lab safety

OTHER DUTIES:

v  Other duties and projects as assigned

v  Comply with XOMA’s Policies and Procedures

QUALIFICATIONS/REQUIREMENTS

Education and/or experience:

v  BA or BS and a minimum of 5 years of experience preferably in QC/QA lab area

v  Good understanding and solid technical aptitude in instruments and methods

v  Familiarity with 21 CFR Part 58 GLP regulation a plus

To apply for this job, please send us an e-mail with your resume and cover letter.