Perform tasks to ensure quality of ongoing data generated by QC with supervision and direction.
• Carry out assignments within the Department of Quality Control as directed by his/her direct supervisor.
• Audit raw data generated during analytical testing of raw materials, in-process materials and finished products for accuracy, completeness and compliance with test method
procedures, specifications, cGMPS, and internal SOP requirements.
• Verify user designed software algorithms by manual calculations.
• Review LIM's reports of the results of analytical testing of raw materials, in-process materials, and finished products for accuracy, completeness and compliance with test method
procedures and specifications.
• Review raw data generated during method validation/verification for accuracy and compliance with test method procedures, validation protocols, cGMPS, and internal SOP
• Must be computer literate; knowledge of LIMS preferred
• Must have a knowledge of USP analytical procedures and some analytical techniques
• Knowledge of cGMP regulations
• Bachelor's degree in chemistry or related science preferred or 2-3 years of professional experience in data auditing or a combination of education and experience
Pharmaceutics International, Inc. (“Pii") is proud to be an Equal Opportunity Employer, including supporting applicants and employees with a disability or protected veterans, as well as any other status protected by law.