Stability QA Engineer - Pharma - needed for Miami, FL!
Manages and coordinates all activities associated to the Site Stability Program. Creates stability study protocols to support new or existing product stability studies to support New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), Investigational New Drug Applications (IDs) and/or marketed drug products.
Establishes testing schedules for each product placed on stability.
Monitoring of stability samples through the stability period and ensuring that sample pulls are performed on a timely manner.
Coordinates sample testing with the QC Lab and ensures that testing is completed on time.
Assessment of Stability Indicating Methods.
Preparation of Stability Reports.
Determination of product expiry date based on analysis of stability data.
Responsible for other QA activities as determined by Quality Management
“Other duties as assigned”
10 or more years in related field.
Thorough understanding of cGMP.
Drug product stability studies and ICH Guidelines, in particular Topics Q1A, Q1D, Q1F, and Q1E.
Excellent knowledge of Windows, Word and Excel.
Able to effectively communicate in English written and oral.
Good analytical and observation skills.
Good knowledge of basic mathematical skills, including measurement.
Statistical analysis is a must (Linear regression, ANCOVA, Poolability, etc.).
Able to multi-task.
Able to follow routine verbal and/or written instructions.
Able to work under pressure and meet deadlines.
Bachelor’s degree in natural sciences, Biology, Chemistry, or Biochemistry, etc. from an accredited U.S. institution, or equivalent.
Direct Hire Opportunity
Salary - $70k/yr
Only local candidates will be considered as no relocation or per diem is available. Candidates must be able to successfully pass a background check and drug screen. Salary based on experience. Candidates must apply through the "Apply Now" function for consideration, or create a profile at www.AdeccoUSA.com then attach a MS Word resume to this posting. Qualified candidates will be contacted for interview. NO PHONE CALLS, PLEASE.
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