WuXi AppTec

Technical Specialist

Job Locations US-GA-Marietta, Georgia
Job ID
2021-8815

Overview

WuXi AppTec is a leading global pharmaceutical, medical device open-access capability and technology platform company with global operations. We have an opening for a Technical Specialist. 

The Technical Specialist will be responsible for providing to clients the expertise, consultation and technical guidance for validations and custom studies through the development of validation and test plans in one or more of the following areas: microbial / antimicrobial studies, sterilization validations, reusable medical device reprocessing and bacterial endotoxin tests.

Responsibilities

  • Uses knowledge of industry standards including USP Microbiological Tests, ASTM and AATCC antimicrobial methods, ANSI/AAMI/ISO microbial tests and FDA Guidance documents to provide input and direction for validations.
  • Provide expertise, consultation, study planning & study support for internal & external clients.
  • Assist in writing, implementation, and maintenance of standard operating procedures, sample test instructions, study and validation protocols & technical documents.
  • Create and/or provide technical review and approval of standard operating procedures, sample test instructions, study and validation protocols & technical documents.
  • Creates Test Method Appendices and Sample Test Instructions in STARLIMS.
  • Provides technical support during quality, client and regulatory inspections/audits.
  • 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.
  • Interacts with clients to discuss study planning and testing issues.
  • Interacts with internal staff to identify area requiring further improvement or development and oversees the implementation of these improvements.
  • Author technical literature specific to the WuXi AppTec – Atlanta Microbial and Antimicrobial Testing services.
  • Support Business Development through webinars, business review meetings, face-to-face presentations, training, etc.

Qualifications

Experience / Education:

  • Bachelor’s Degree in Microbiology, Biotechnology, Biology or equivalent
  • 5 years of relevant industry experience with high level understanding of validations and test method development

Knowledge / Skills / Abilities:

  • Experienced and proficient in one or more of the following areas:
    • USP Microbiological Tests
    • ANSI/AAMI/ISO microbial tests related to medical devices
    • AATCC Test Microbial methods associated with textiles and plastics used in the medical device industry
    • ASTM microbial and antimicrobial methods
    • Disinfectant / Sanitizer Efficacy Studies
  • Demonstrates a clear understanding of the contract laboratory testing business and effectively manages client study timelines, budget and compliance to ensure successful, timely study 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 perform complex arithmetic calculations, dilutions, and statistics accurately and reproducibly.
  • Ability to critically think and 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 regulatory compliance.
  • Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
  • Ability to work in a team environment and independently as required
  • Ability to analyze and interpret data
  • Excellent problem solving, risk analysis and negotiation skills.
  • Proficient in Oral & Written communication skills
  • Need to be able to read, write and understand English
  • Proficient in Microsoft Office applications (Excel, Word, Outlook)

Physical Requirements:

  • Must be able to work in an office environment with minimal noise conditions
  • Must be able to wear appropriate PPE
  • Ability to stand / sit / walk for long periods of time
  • Ability to crouch, bend, twist, and reach
  • Clarity of vision; ability to identify and distinguish colors
  • Must be able to perform activities with repetitive motions

 

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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