Chromatography Data System Administrator

Operations Seymour, Indiana


Description

  JOB SUMMARY:    

 

  • This position is primarily responsible for administration of all lab software systems.

B.  ESSENTIAL DUTIES / RESPONSIBILITIES: 

 

  1. Administrative oversight of all lab software systems (except LIMS), with primary focus on the Chromatograpy Data System (CDS)

  2. Provide backup Administrator functions for LIMS

  3. Handle inquiries from internal users of lab software systems

  4. Evaluate new lab software systems for 21 CFR Part 11 Compliance

  5. Assist in IQ, OQ, and PQ of all new lab instrument software systems 

 Required Education:
           
Bachelor’s Degree – Chemistry, Mathematics, or related field

QUALIFICATIONS/EXPERIENCE:  

  1. At least 5 years of pharmaceutical testing experience in a cGMP-regulated laboratory environment

  2. Knowledge of cGMP, USP/NF, ICH, EU and FDA guidelines and regulations

  3. At least 3 years of experience with a Chromatography Data System (Chromeleon preferred)

     

SPECIFIC SKILLS:

  • Excellent oral communication skills and technical writing skills

  • Well organized, detail-oriented, and dependable

  • Demonstrated ability to work as part of a cross-functional team

  • Able to assist with troubleshooting analytical methods and laboratory instrumentation (e.g. HPLC, GC)

PHYSICAL REQUIREMENTS/ENVIRONMENT:  

  • Primarily office setting with occasional bending and working in cramped quarters making computer connections