Quality Control Instrument Support Specialist

About this opportunity :

In this role you'll be responsible for system administrator duties involving the analytical instruments and associated software within the Analytical lab.  Ensures instruments are qualified and maintained through preventative maintenance and re-qualification programs. The position is the main contact point for Metrology services and contract vendors.  Additionally, if future demand requires it, the position may have an additional direct report.   

 

Key Responsibilities:  

 

• System Administrator duties for analytical instruments and associated software, including back-up and archival of data. 
• Maintain instrument qualifications and re-qualifications and per site SOP’s and Vendor Service Agreements.   
• Plan and Coordinate Instrument PMs and qualifications with Vendors.   
• Coordinate Qualification Activities with the QA, Validation, and Metrology departments, including the facilitation of any associated CCRs and CAPAs.   
• Maintenance of Instrument Qualification procedures including lock-out / tag-out of out of service instrumentation.   
• Provide training and guidance to analysts, associates, and chemists on new equipment, where applicable.   
• Develops / revises QC documents within their scope of expertise. 
• Assist personnel with the troubleshooting of analytical method problems within the confines of instrument related events 
• Execute and review qualification protocols and ensure compliance with current industry guidelines.   
• Review of executed qualification protocols to ensure accuracy and completeness. 
• Establish equipment maintenance and cleaning procedures and implement a cleaning and maintenance schedule. 

 

Required Skills/Abilities: 

 

• BS in a relevant field science 
• 8+ years of experience in a cGMP laboratory environment 
• Strong analytical skills with extensive background in instrumentation including but not limited to:  HPLC, LCMS, Karl Fischer, GC, etc. 
• Proficient in the usage of various software packages. 
• Interpersonal skills to lead and train QC staff 
• Knowledge and Experience with Scheduling and Planning in an analytical laboratory 
• Strong Data Review skills