WuXi AppTec

Technical Specialist

US-GA-Marietta
Job ID
2017-3267

Overview

The Technical Specialist will be responsible for providing expertise, consultation and technical guidance for Microbial Testing including, but not limited to, Total Viable Spore Count, USP <51> Antimicrobial Effectiveness Test, USP <61> Microbial Enumeration Tests, USP <62> Tests for Specified Organisms, biofilm testing and custom studies for clients through the development of validation and test plans.  Perform job specific tasks in compliance with applicable Regulations, International Standards, Compendia and WuXi AppTec Policies and SOPs.

Responsibilities

  • Provide expertise, consultation, project planning and project support for internal and external clients.
  • Assist in writing, implementation, and maintenance of standard operating procedures, client test procedures, study and validation protocols & technical documents.
  • Performs technical review and approval of standard operating procedures, client test procedures, study and validation protocols & technical documents.
  • Provides technical support during quality, client and regulatory inspections.
  • Interacts with the Regulatory Affairs and Quality Assurance departments to remain informed and current on industry standards.
  • Meet customers’ expectations by striving without reserve for the greatest possible reliability and quality in our services.
  • Provide client technical communications related to Microbial Testing,  Total Viable Spore Count, USP <51>, <61> & <62> Testing, biofilm testing and custom studies.
  • Interacts with clients to discuss project planning and testing issues.
  • Interacts with internal staff to identify area requiring further improvement or development and oversees the implementation of these improvements.
  • Function as management review for nonclinical laboratory studies and as a Study Director.
  • Author technical literature specific to business.
  • Support Business Development through webinars, business review meetings, face-to-face presentations, training, etc.
  • Routinely perform review of departmental SOPs to ensure regulatory compliance.
  • Write protocols and final reports for custom studies focusing.


Qualifications

  • Bachelor's degree in life science or equivalent experience
  • 5 years experience in relevant industry with high level understanding of Microbial Limits testing.
  • Ideal candidate will have experience performing USP <61> & <62> Testing / Suitability Testing.
  • Demonstrates a clear understanding of the contract laboratory testing business and effectively manages client project timelines, budget and compliance to ensure successful project execution.
  • Ability to receive, comprehend and effectively communicate detailed information through verbal and written communication.
  • Ability to evaluate technical data and write technical documents.
  • Ability to accurately and reproducibly perform complex arithmetic calculations and statistics.
  • Ability to make decisions based on a wide knowledge of factors where application of advanced or technical concepts is predominantly required. 
  • Has a strong working knowledge of the regulatory compliance.
  • Excellent problem solving, risk analysis and negotiation skills.
  • Direct client contact experience.
  • Ability to perform client presentations in a professional, concise manner.
  • Perform primarily sedentary work.

 

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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