QC Analyst I

Your Role 

Technical entry level position responsible for analytical testing of finished product, raw materials, stability and special test requests. Position also needed analytical testing in support of protocols related to method transfers, method validations, laboratory investigations, and instrument qualifications. 
  

Major Position Activities & Responsibilities: 

• Responsible for adhering to the Environmental, Health and Safety program.   

• Perform routine analytical testing for in-process and finished products.  

• Perform routine analytical testing for raw materials, special test requests, laboratory investigations, and instrument qualifications according to validated methods.  

• Perform common laboratory procedures such as pH, weighing on analytical balances, glassware prep, equipment calibrations, and peer review of test parameters and reagent preparations.  

• Support manufacturing process control & process improvement projects.  

• Assist in the execution of protocols for method transfers, method validations, stability studies, and cleaning validations.  

• Review of analytical test procedures as needed.  

• Performs routine lab maintenance, special projects, and other duties as assigned.  

• As a part of the employee’s job requirements, the employee may be requested to handle wastes including hazardous wastes.  

• The employee expected to attend mandatory annual hazardous waste training meeting(s) and show competency in that training by passing test(s) administered by the company or consultant providing such training. 

Scope:  

• 5% Executing protocols for method qualifications, method validations, and qualification of new instruments.  

• 5% Revising SOPs and ACMs for the chemistry lab as directed.  

• 10% Laboratory Maintenance duties  

• 80% Individual contributor as bench analyst 
    

Who You Are 

Minimum Qualifications: 

• Bachelor’s Degree in Chemistry, Biology or other scientific discipline  

 

Preferred Qualifications: 

• Working knowledge of Waters Empower 3 chromatography software.  

• 1+ years of experience in quality control environment 

• Experience with UV/VIS spectrophotometry, FTIR Spectrophotometry, and HPLC/GC chromatography.  

• Familiarity with cGMP in testing/manufacturing environments preferably in pharmaceuticals.  

• Knowledge of bio-analytical and chemistry analytical techniques.  

• Ability to communicate at all levels in a pharmaceutical organization.  

• Good interpersonal skills. 

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