At the moment, Pfizer based in Andover, MA is looking for talented Bioanalytical QC Associate that will responsible for the lifecycle of regulated and clinical samples of biotherapeutics in various matrices to be tested in ligand binding assays on various instrument platforms. Previous experience with focus on sample management / ligand binding assay validation/sample testing and industry experience will be highly considered.
I have attached the detailed job description to this message for your review.
Position Purpose
- Responsible for the lifecycle of regulated and clinical samples of biotherapeutics in various matrices to be tested in ligand binding assays on various instrument platforms.
- Responsible for the routine and non-routine maintenance of lab equipment (e.g. plate washers, plate readers) used in support of regulated and clinical studies.
- Assist with quality control of operational procedures and software applications in accordance with departmental SOPs and bioanalytical methods.
- Sample lifecycle management and lab equipment maintenance to be governed per departmental SOP. Attention to detail to ensure accurate execution and documentation of these processes in a regulatory compliant manner. Knowledge of GLP/GCP and working in a regulated environment is highly desirable.
Primary Responsibilities
- Implement various processes needed to manage a sample’s lifecycle which includes accession, check-in and disposal within a laboratory management system (LIMS). Become proficient in LIMS to conduct these activities in a dynamic environment. Collaborate with external groups to resolve sample discrepancies. Assist in the transmission and formatting of clinical files for the importation/exportation of clinical data from LIMS.
- Execute routine maintenance of lab instrumentation as required per departmental SOPs.
Technical Skill Requirements
• Knowledge and hands-on experience with sample management in a LIMS as well as lab equipment used in support of ligand binding assays.
• Knowledge and hands on experience working under GLP/GCP regulations is highly desirable
• Ability to execute tasks with high quality against challenging time lines
Qualifications (i.e., preferred education, experience, attributes)
• BSc with at least 1+ year relevant experience, with a focus on sample management / ligand binding assay validation/sample tesing; preferably in a GLP/GCP laboratory;
• Industry experience with a focus in biotherapeutics; familiarity with LIMS and instrumentation used in execution of ligand binding assays.
• Skills in GLP/GCP compliant laboratory including following SOP and provision of quality regulatory documents is highly desirable.
All your information will be kept confidential according to EEO guidelines.
IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 646-357-1104 ASAP!
I look forward to hearing from you!
