QC Lab Analyst VI-VII

States considered: Michigan

Role Description

The QO Lab Analyst position works effectively in a fast-paced, customer-oriented, team laboratory environment to analyze finished product samples prior to commercial release.  This is a dynamic, growing lab within a growing manufacturing site with opportunity to learn new skills and to work cross-functionally. 

·       Performs, documents and record checks qualitative and quantitative assays on samples.   

·       The primary technologies in this lab are HPLC, Dissolution and KF.  

·       Interprets and evaluates data for accuracy, precision, trends, and potential GMP impact. 

·       Recommends and executes process improvements to continually improve laboratory performance.  

·       High productivity and the ability to multi-task coupled with a low error rate and attention to detail are critical characteristics of this position. 

·       Demonstrates flexibility/agility and engagement in a changing environment.   

·       The candidate is expected to display good laboratory technique to avoid cross-contamination or misidentification of samples. 

·       Ability to follow written procedures. 

·       May train others. 

·       Troubleshoot instrumentation. 

·       Review documentation of other analysts. 

·       Participates in laboratory investigations as required. 

·       As a Level VI or VII analyst, the selected candidate will be expected to contribute to the success in multiple ways including, process and method improvements, training, and demonstration of efficient work practices. 

·       May participate in manufacturing QC support such as cleaning verification. 

·       SHIFT HOURS: 8:00pm-4:30pm, nominally (some flexibility is allowed).  Overtime may occasionally be required. 

EDUCATION AND EXPERIENCE 

·       AAS, BA/BS, or MS in Chemistry, Biochemistry, or related science preferred. 

·       5 years minimum related experience in Quality Control. 

·       Preferred experience includes GMP documentation, drug product formulation, in-plant laboratory, Incoming Inspection, SAP, LIMS, HPLC, Dissolution, use of Empower3 

·       Key characteristics of a successful candidate in this position: willingness and ability to learn, ability to work in a team environment, and attention to detail. 

·       Job duties involve occasional lifting (less than 35 lbs). 

Candidate must not be Cephalosporin/Penicillin sensitive.