Laboratory Technician II

Overview

Performs any basic to complex Analytical and microbiological assay(s) according to and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). Completes Test Methods and other required documentation and performs laboratory maintenance duties according to GLP, cGMP, CFR and/or PTC guidelines and SOPs. Performs daily work activities with minimal supervision.  Sufficiently competent in science to initiate and carry out scientific development projects related to the development of new assays, initiation of new programs, assay validations and associated projects. Performs and thoroughly documents Research & Development activities as required

Responsibilities

• Conducts any basic to complex Analytical and microbiological assays and lab procedures according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs.
• Accurately completes Test Methods and other required documentation according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs.
• Follows all general and laboratory SOPs
• Maintains a laboratory notebook for Research & Development activities as required
• Conducts critical review of results and reports data to Technical Reviewer or supervisor
• Communicates with supervisor and other colleagues re: daily lab activities
• Prepares reagents and completes reagent batch records
• Checks reagents for expired chemicals and disposes of any expired reagents
• Performs laboratory maintenance (i.e. decontaminates and disposes of medical and other waste as appropriate, maintains laboratory supply inventories, keeps work surfaces clean and neat) and keeps records of maintenance according to guidelines and SOPs
• Performs routine equipment monitoring and cleaning (i.e. centrifuges, biosafety and chemical hoods, refrigerators, incubators and freezers) and keeps records according to guidelines and SOPs
• Orders reagents, media and consumables as required and uses commodity specification procedure as assigned
• Completes all requisite training (i.e. Bloodborne Pathogen, Quality Assurance, safety, etc.)
• Contributes to the preparation of Protocols, Testing Records and Final Reports, as needed and with supervision. Revise existing SOPs as assigned by Management
• Author investigations and deviations with minimal supervision
• Demonstrates proficiency in scientific theory and applies scientific rigor in the laboratory
• Correctly analyzes scientific data with accuracy and precision
• Performs daily work activities with minimal supervision
• Communications inventory needs to Materials Management personnel and contacts suppliers for technical information as needed.
• May author Test Methods, Client Protocols, SOPs, etc. as needed.
• Initiate and write nonconformance and laboratory investigations.
• Participate in R&D projects and assay validations.
• Provides operational support for Cell Biology activities including (Ex. media/buffer preparation, cleaning activities, and equipment/materials staging/ Aseptic Technique).
• Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Normally receives minimal instructions on routine work and detailed instructions on new assignments.
• Ability to work in a team environment and independently as required
• Maybe required to work Holidays and weekends
• Maybe required to work Overtime 
• 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.
• Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
• Other duties as assigned
• May be required to assist in other departments
• May be required to work Holidays and weekends
• May be required to work Overtime

• Other duties as assigned

Qualifications

• Strong Technical and Scientific knowledge of microbiological based assays (i.e. Sterility, Endotoxin Gram Stain, etc).
• Knowledge of microbiological based assays such as Gram stain, plate counts and serial dilutions, sterility test, bacteriostsis/fungistatis test, bactometer, and Bacterial Endotoxin Test.
• Good aseptic technique
• Familiarity with sterility testing isolators
• Ability to use proficiently advanced laboratory equipment, such as, but not limited to; Plate Readers, HPLC, Gel scanners, etc.
• Shows excellent time management skills
• Ability to record data accurately and legibly.
• Ability to understand and follow verbal and demonstrated instructions.
• Ability to clearly express and exchange ideas by means of verbal and written communication.
• Ability to work effectively as part of a team and exhibit effective interpersonal skills.

 Physical Requirements:

• Must be able to work in Lab setting with Biohazards /various Chemicals
• Must be able to wear appropriate PPE.
• Must be able to work in environment with variable noise levels.
• Ability to stand or sit for long periods of time.
• Ability to perform light physical work, lifting up to 20 pounds as needed.
• Ability to crouch, bend, twist, and reach.

• Clarity of vision at all ranges, depth perception, and ability to identify and distinguish colors.

• Must be able to perform activities with repetitive motions.
• Inside working conditions.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

Our Values:

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 

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability