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QC Manager (Validation)

Company: nxtgen search
Location: Torrance
Posted on: March 22, 2020

Job Description:

JOB SUMMARY The Manager, Validation is to manage the validation and development stage analytical testing within the QC department to ensure that all department activities in compliance with current GMP rules and regulations QUALIFICATIONS: Maintain and coordinate the operation of the validation/method development department in coordination with client/company/regulatory goals. This includes prioritizing work for development/validation with the validation personnel on a regular basis Review laboratory notebooks, raw data, development/summary reports, protocols and operational SOPs as necessary Maintain and coordinate the operation of the stability department in coordination with client/company/regulatory goals. This includes prioritizing work for stability testing with the stability personnel on a regular basis Oversee the execution of validation and stability protocols activities and ensure adherence to GMPs and any other regulatory guidelines Work with clients via teleconferences/meetings to ensure their goals are met and the methods and data are delivered to them. Ensure information is suitable for their intended use and received in a timely fashion. Keep open channels of communication with the customer and provide status updates as necessary Author and/or review validation & stability protocols, validation & stability reports and method development reports, as necessary. Write standard operating procedures, standard test procedures and other related GMP documentation. Review data for completeness and accuracy ESSENTIAL FUNCTIONS AND RESPONSIBILITIES PhD in Chemistry or Biochemistry with a minimum of 5 years' experience in peptide analytical chemistry or Master's Degree in Chemistry or Biochemistry with a minimum of 7 years' experience in peptide analytical chemistry or Bachelor's Degree in Chemistry or Biochemistry with a minimum of 9 years' experience in peptide analytical chemistry Broad knowledge of modern analytical chemistry Extensive experience in GMP laboratory testing Hands-on experience with HPLC, GC, MS, LC-MS Methods development experience Experience writing standard operating procedures (SOPs) and technical reports Prior supervisory and project management experience Thorough understanding of peptides and their chemistry

Keywords: nxtgen search, Torrance , QC Manager (Validation), Executive , Torrance, California

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