WuXi AppTec Technical Specialist in Marietta, Georgia
The Technical Specialist provides expertise, consultation and technical guidance for radiation validations, radiation dose audits, steam sterilizations, dry time studies, industrial and hospital EO sterilization validations, and reprocessing validations for single-use and reusable medical devices. Interacts with clients, account managers, and other Technical Services team members as appropriate.
Uses knowledge of industry standards including but not limited to AAMI, ISO and PDA as well as FDA Guidance Documents in order to provide technical guidance on custom testing, generate quotes, develop testing protocols, and write final reports.
Provides client technical communications related to sterilization validations and reprocessing studies including testing requirements, test method development, method validation, scheduling, and reporting.
Support Business Development to service client needs.
Creates Test Method Appendices and Sample Test Instructions in STARLIMS for bioburden and sterility test methods.
Interacts with internal staff to identify area requiring further improvement or development and oversees the implementation of these improvements.
Represents WuXi AppTec at industry conferences, trade sho ws and client meetings.
Assists in writing, implementation, review and maintenance of Standard Operating Procedures and client test procedures as well as other technical documents.
Provides technical support during client audits and regulatory inspections.
Interacts with the Regulatory Affairs and Quality Assurance departments to remain informed and current on industry standards.
Routinely perform review of departmental SOPs to ensure regulatory compliance.
Serve as Study Director for applicable GLP studies.
May be required to work some Holidays and weekends.
Contributes to the achievement of departmental, site and corporate goals.
Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
Adherence to Good Laboratory Practices and Good Manufacturing Practices as applicable.
May be required to assist in other departments.
Other duties as assigned.
Bachelor’s Degree with a minimum of 5 years relevant experience, or
Associate’s Degree with a minimum of 10 years of relevant experience
Preferred experience in managing terminal sterilization validation programs in one or more of the following areas: radiation (gamma and/or e-beam), Ethylene Oxide, Moist Heat. Candidates should also possess a thorough working knowledge of the associated AAMI/ISO standards.
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.
Proficient in Oral & Written communication skills
Ability to effectively communicate complex technical concepts
Ability to analyze and interpret data
Ability to focus for long periods of time with a high attention to detail
Individual must thrive in a fast paced, multitasking environment with minimal supervision.
Ability to work in a team environment and independently as required
Experience in an FDA regulated industry is preferred.
Need to be able to read, write and understand English
Proficient in Microsoft (Excel, Word, Outlook, PowerPoint)
Perform primarily sedentary work.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Job ID: 2017-3036
External Company Name: WuXi AppTec Inc
External Company URL: http://wuxiapptec.com