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Microbiology Specialist II

Employer
WuXi AppTec
Location
Marietta, Georgia, US
Salary
Competitive
Closing date
Sep 30, 2022

View more

Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Statistics, Biology
Salary Type
Salary
Employment Type
Full time
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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 II.

The Technical Specialist II will be responsible for providing 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.

The anticipated work schedule is Mon-Fri standard business hours.

Responsibilities:
  • Uses knowledge of industry standards including ANSI/AAMI/ISO, USP, 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.
  • Performs 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.
  • 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 radiation validations/dose audits, reusable device validations & custom studies for clients through the development of validation & test plans.
  • Interacts with clients to discuss study planning and testing issues.
  • Interacts with internal staff to identify areas requiring further improvement or development and oversees the implementation of these improvements.
  • Author technical literature specific to the WuXi AppTec - Atlanta services.
  • Support Business Development through webinars, business review meetings, face-to-face presentations, training, etc.
  • Routinely perform reviews of departmental SOPs to ensure regulatory compliance.
  • Write protocols and final reports for custom studies focusing.
  • Function as management review for nonclinical laboratory studies and as a Study Director.
  • Normally receives minimal instructions on routine work and detailed instructions on new assignments.
  • Works under close supervision from supervisor or senior personnel.
  • Contributes to the overall operations and to the achievement of departmental goals
  • Perform job-specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
  • May be required to work holidays and weekends
  • May be required to assist in other departments
  • Other duties as assigned


Experience / Education:
  • Associates or Bachelor's Degree or equivalent
  • 5 years of relevant industry experience with high-level understanding of validations and test method development
  • Experienced and proficient in one or more of the following areas:
  • Radiation and EO validations/dose audits
  • Reusable device validations and custom studies
  • USP Microbial Enumeration Tests and USP Tests for Specified Organisms, USP Total Viable Spore Count, USP Antimicrobial Effectiveness Test, USP , , ANSI/AAMI ST72 Bacterial Endotoxin, USP , ANSI/AAMI/ISO 11737-2 Sterility Test, ANSI/AAMI/ISO 11737-1 Microbiological Methods- Bioburden
  • AATCC Test Methods, ASTM Biofilm
  • Disinfectant / Sanitizer Efficacy Studies and Environmental Monitoring
  • 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 accurately and reproducibly perform complex arithmetic calculations and statistics.
  • Ability to make critically think and make decisions based on a wide knowledge of factors where the application of advanced or technical concepts is predominantly required.
  • Has 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)
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