Xenobiotic Laboratories (XBL), a subsidiary of the Lab Testing Division of WuXi AppTec, Inc., is a leading contract research laboratory specializing in small and large molecule Bioanalytical, drug metabolism, and pharmacokinetic services to the pharmaceutical, animal health and agrochemical industries. Xenobiotic Laboratories is seeking an Quality Control Associate II within QC Department located in Plainsboro, NJ.
This position supports the Quality Control functions for the NEJ site with focus on one or multiple departments. Raw data, notebook, logbook and reports (among other sources) are reviewed against preplanned procedural documentation such as SOPs, plans, protocols, methods, etc. Findings from the QC reviewer are brought to the lab's responsible person(s) attention for correction, and those materials are then returned to QC for correction action confirmation.
Essential Job Functions:
The Quality Control Associate II will be responsible for review and commentary on laboratory raw data, procedures and reports to ensure methods, protocols and other procedures were properly followed, results are analytically accurate and correct, and that all documentation meets GLP standards.
Responsible for checking raw data results in Watson LIMS (Laboratory Information Management System) database for acceptability of data and completeness of method validation experiments/study sample analysis (Bioanalytical and Biologics).
Performs various mathematical calculations including subtraction, addition, multiplication, division, and statistical analysis including means, standard deviations, coefficient of variation (% CV), percent change, percent difference, etc.
Responsible for checking raw data, notebook documentation, CoA records, sample shipment records, solution preparation logbook pages, etc. against pre-planned procedural documents such as SOPs, methods, method validation plans, sample analysis outlines, etc. and citing for overall Good Laboratory Practices (GLP) adherence.
Responsible for checking raw data from MSD and SoftMax software for large molecule therapeutics, including analysis using appropriate software applications.
Responsible for checking LC-MS/MS chromatograms for small molecule studies via Analyst and MassLynx integration software.
Verifies that data entered in spreadsheets are correctly transcribed from the source data and that Excel formulas are applied correctly, with correct rounding, etc.
Work with analysts to complete any corrections to laboratory notebooks, data summary and reports.
Perform detailed experimentation records review for test results assays such as ELISA, cell culture.
Perform detail review of method qualification, method validation and sample analysis reports, including verifying text, tables and figures in reports.
Independently perform Quality Control review function.
Provides support services to Quality Assurance Unit as requested.
Thorough understanding of Good Laboratory Practices pertaining to the study.
Promotes implementation and compliance with WuXi AppTec safety policies, practices, and procedures in order to maintain a safe work environment and minimize or eliminate injury.
Provide training to QC Associate I/IIs.
Other duties as assigned.
Experience / Education:
Bachelor of Science in Chemistry, Biochemistry, Biological Sciences or related field.
Previous experience with ELISA, LC-MS and LIMS database software strongly preferred
Experience reviewing data for large molecule and/or small molecule, including analysis using appropriate software applications
2-4 years of relevant experience, or equivalent
1-2 years of relevant experience in laboratory bench work, or equivalent is a plus
Any similar combination of education and experience.
Knowledge / Skills / Abilities:
Knowledge of commonly used concepts, practices, and procedures within QC/data auditing field.
Understanding of immunoassay/ligand binding assay techniques employed quantification of protein therapeutics in biological matrices.
Well organized and detail oriented; works well with numbers.
Interacts with Operations, Scientific and Management team members. Effective oral and written communication skills.
Effective interpersonal skills.
Computer skills: knowledge of internet research, MS Word, Excel, Outlook, and PowerPoint.
Ability to work under pressure with multiple projects and deadlines and maintain high level of accuracy and efficiency.
Ability to effectively prioritize workload and manage changes in direction.
Ability to work and promote harmony in a team environment.
Familiarity with and adherence to regulatory guidelines consistent with WuXi AppTec requirements
Overtime and weekend work as required.
Must be able to work in an office environment with minimal noise conditions
Must be able to work on a minimal basis in a lab setting with exposure to organic solvents, acids, bases, animal and human matrices, low levels of radioactivity, biohazardous waste/sharps
Must be able to wear appropriate personal protective equipment (PPE)
Ability to sit for long periods of time
Ability to look at a computer screen for long periods of time
Ability to lift/push/pull upwards of 20 lbs routinely
Must be able to perform activities with repetitive motions
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
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.