WuXi AppTec is a leading global pharmaceutical, medical device open-access capability and technology platform company with global operations. We have an opening in our Technical Development Department for a Laboratory Coordinator. The Laboratory Coordinator adheres to client study timelines, coordinating with laboratory schedules so study results are generated on time and prepares the final client study report. May interact with: clients to ensure samples and materials are received, account managers to ensure accuracy of quotes, laboratory personnel to review study protocols and testing design, WuXi AppTec subcontractors, and Technical Services team members as appropriate.
Assists with the creation of Standard Test Instructions (STI's) related to custom studies and programs.
Serves as GLP Study Director for client sponsored GLP studies.
Maintains study documentation including records of communications, study schedules, sample chain of custody, laboratory data, results and reports.
Monitors studies daily.
Serves as client technical support.
Keeps clients updated in a timely manner regarding progress of study, decision points, study deviations, laboratory errors and timeline impacting events.
Informs internal resources of study updates ensuring timely communications.
Logs study samples into STARLIMS.
Coordinates updates to quotes to include any necessary changes in scope of study, ensures that testing is performed as per executed contract, and notifies Technical Services management of any study changes or deviations.
Invoices studies as per the executed contract to ensure appropriate billing of all services.
Works with minimal supervision.
Performs some study analysis, data interpretation and reporting of results.
Experience / Education
Associates or Bachelor's Degree in Life Science field or equivalent experience
2-3 years of relevant experience outside of school
Experience in one or more of the following: Medical Device Reprocessing, equipment cleaning validation, steam sterilization validation, hospital disinfectant and sterilization practices, AAMI, ASTM, AATB, or AATCC chemistry and/or microbiology testing methods.
Knowledge / Skills / Abilities:
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
Demonstrates a clear understanding of the contract laboratory testing business and effectively manages laboratory operations to address compliance, customer and business needs in a timely manner.
Ability to receive and comprehend and to effectively communicate detailed information through verbal and written communication
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
Need to be able to read, write and understand English
Proficient in Microsoft (Excel, Word, Outlook)
Perform primarily sedentary work.
Must be able to work in environment with variable noise levels.
Must be able to work in lab setting with exposure to biohazards / chemicals.
Must be able to wear appropriate PPE as needed.
Ability to stand / sit / walk for long periods of time
Clarity of Vision: ability to identify and distinguish colors
Must be able to perform activities with repetitive motions.
Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.
WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.