Job Posting: QC Analyst I
Technical entry level position responsible for analytical testing of finished product, raw materials, stability and special test requests. Position also requires 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, andcleaning validations.
- Review of analytical test procedures as required.
- Performs routine lab maintenance, special projects, and other duties as assigned.
- As a part of the employee’s job requirements, the employee may be required to handle wastes including hazardous wastes. The employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such training.
- 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
- BS in chemistry or related discipline with a minimum of one year of experience in the pharmaceutical industry.
- Must have familiarity with cGMP in testing/manufacturing environments preferably in pharmaceuticals.
- Working knowledge of Waters Empower 3 chromatography software desired. Experience with UV/VIS spectrophotometry, FTIR Spectrophotometry, and HPLC/GC chromatography highly desired.
- Knowledge of bio-analytical and chemistry analytical techniques.
- Ability to communicate at all levels in a pharmaceutical organization. Good interpersonal skills are a must.