Teva Pharmaceuticals Research Associate QC - Sr Research Associate QC (Biologics) in West Chester, Pennsylvania
Teva Biologics is currently seeking a Research Associate or Senior Research Associate on ourLaboratory Operations and Compliance, Biologics, Assays and Technology (GBT) team.
We are seeking a highly motivated individual with experience in supporting pre-clinical (GLP) and clinical regulated studies. The position will focus on review of data generated from validation and sample analyses of biologics (large molecules)to ensure data quality and integrity. You will be a member of Biologics, Assays and Technology, which plays a critical role in development of biological therapeutics from early stage research, IND enabling GLP studies, clinical trials through BLA submission and post marketing support.
• Performs thorough review of data and supporting documentation in support of immunogenicity and PK/PD/Biomarker method validation and studies.
• Attends regulatory training, SOP training, general laboratory/safety training
• Assist in sample tracking and management in Watson LIMS
• Participate in interaction/meetings with QA regarding data review schedules
• Assist with documentation and record management
• Ensure compliance, data quality and integrity
M.S. in a related field with a minimum of 1 year or a B.S. in a related field with a minimum of 5 years of bioanalytical experience in pharmaceutical, biotechnology, and/or CRO industry.
Previous experience in Data Review (QC) in support of large molecule assays is required.
Proficiency in Microsoft Office, SoftMax and Watson LIMS, and knowledge on data integrity and regulatory requirements are expected.
The candidate must be able to work collaboratively in a diverse, fast-paced environment with ability to multi-task.
Good communication and interpersonal skills are required.
This role can filled at Research Associate or Senior Research Associate level depending upon the qualifications of the candidate.
Requisition # 17-19343
# Positions ..
Location US-PA-West Chester
Experience (Years) 5
Category Research & Development - Biopharmaceutics
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.