WuXi AppTec Laboratory Technician, Environmental Monitoring in Philadelphia, Pennsylvania
Responsible for performing sampling and testing in support of manufacturing and validation activities. Works in a team environment with various laboratory staff. Performs assays according to and in compliance with current Good Manufacturing Practices (cGMPs), Code of Federal Regulations (CFR) and Standard Operating Procedures (SOPs). Under direct supervision, completes batch records and other required documentation and performs laboratory maintenance duties according to cGMPs, CFR and SOPs.
Works on special projects as assigned by Management.
Conducts critical review of environmental results and reports data to appropriate internal staff members.
Submits Document Change Requests (DCRs) and writes SOPs.
Orders laboratory supplies when needed.
Collects water and clean steam samples.
Tests compressed gases for bio-burden, non-viable particles, water vapor and hydrocarbons.
Performs Quality Control (QC) of media and reagents.
Performs environmental monitoring.
Assists with the purchase and qualification of laboratory equipment.
Effectively interacts with other staff members, supervisor and lab customers.
Meets timeliness and goals established with lab customers.
Maintains the priority of delivering bioburden data on schedule.
Conducts assays and lab procedures according to and in compliance with cGMPs, CFR and SOPs.
Accurately completes batch records and other required documentation according to and in compliance with cGMPs, CFR and SOPs.
Follows all general and laboratory SOPs.
Performs assays using appropriate laboratory techniques for lab group assigned to.
Reports observations of ongoing tests to Quality Assurance (QA) and Management.
Communicates with colleagues re: daily lab activities.
Performs laboratory maintenance (i.e. decontaminates and disposes of medical 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, bio-guard and chemical hoods, pipette-man, refrigerator and freezers) and keeps records according to guidelines and SOPs.
Prepares reagents and completes reagent batch records.
Checks reagents for expired chemicals and disposes of any expired reagents.
Completes all requisite training (i.e. Bloodborne Pathogen, Quality Assurance, safety, etc.).
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
Experience / Education:
1 or more years of experience
Bachelor’s degree with major in Microbiology or Biology
Knowledge / Skills / Abilities:
Knowledge of microbiology, proteins and experience working with large molecules in the laboratory is preferred.
Proficiency with multiple microbiological laboratory skills, including aseptic techniques and bioburden testing.
Flexibility and willingness to learn new technologies and microbiological method is needed.
Pays close attention to detail.
Participates actively in team activities and supports team decisions.
Accepts responsibility for personal actions and quality of laboratory work and accepts constructive feedback.
Ability to accomplish the described duties through the use of appropriate laboratory equipment (i.e. biohazard hood, centrifuge, incubator, and autoclave) and computer equipment and software. (i.e. Microsoft Word, Outlook).
Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled
Job ID: 2018-3765
External Company Name: WuXi AppTec Inc
External Company URL: http://wuxiapptec.com
Street: 4751 League Island Blvd