Mentor, train, and supervise quality control staff, as well as evaluate performance and provide opportunities for growth.Manager analyst schedule to support Drug Product Testing.Review/approve QC laboratory data for validity and accuracy according to cGMP/cGLP standards.Review/approve documents as a QC department subject matter expert (SME).Oversee timely completion of laboratory investigation of OOS/ invalid assays, CAPAs and change controls.Ensure accuracy and completeness of executed analytical method transfer activities.Set testing priorities and manage work assignments.Communicate department objectives and metrics.Support internal and Health Authority audits, as well as audit related investigations.

Perform testing of in-process, final product, and stability samples.Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.Anticipate and troubleshoot problems.Recommend corrective actions and participate in development of best practices.Understanding of regulatory guidelines and can independently develop, write and execute methods, protocols, reports and other related documents.Complete all work in a timely manner.Work and communicate effectively within the team to ensure timelines are met.Perform peer review of testing data.Review all data in accordance with applicable procedures and cGMP requirements.Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.Complete all review in accordance with required release timelines.Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.Train new analysts to general job duties.Complete necessary training to become a qualified trainer.Perform training effectivelyDocument training per procedural and cGMP requirements.Hands on experience with various bioanalytical techniques including ELISA, qPCR and FACS.Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.Technical writing skills.Problem solving ability/mentality, technically adept and logical.Ability to represent the interests of the group on cross-functional teams.Ability to set priorities of the group and manage timelines.Ability to work with management locally and globally.Ability to communicate effectively with peers, department management and cross-functional peers.

Completion of QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environmentEnsure testing is completed in compliance with all applicable procedures, standards and GMP regulationsWork with Process Development team, Quality and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture productsConduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratoriesPerform qualification and validation of test methods Perform peer review/approval of laboratory dataSupport and perform investigations related to lab OOS/OOTPerform training of new hires in regards to in-process testing and other daily assignment or activitiesUtilize electronic systems (LIMS) for execution and documentation of testingCreate, review and approve relevant QC documents, SOP's and WI'sPerform tasks in a manner consistent with the safety policies, quality systems and cGMP requirementsSME and Trainer for Flow Cytometry and other in-process testingInvolved on the site initiative to develop electronic test forms to mainstream QC laboratory processes

Accession and process human pathological specimens (include body tissue, fluid, abscess, sputum, urine and stool) for comprehensive analysis in bacteriology, mycology, parasitology and mycobacteriology.Utilize laboratory applications (SoftLab and SoftMic) and devices (Siemens Microscan, BioMérieux PreviIsola, BD BACTEC fx and BioMérieux MALDI-TOF mass spectrometry).Provide technical support for laboratory scientist and administrative support for clinicians in Morristown Medical Center, Overlook Medical Center, Newton Medical Center, Chilton Medical Center and outreach medical offices.Ability to immediately troubleshoot as well as resolve laboratory issues to optimize work quality and flow.

Review and revise existing compliance policies to ensure that they are up-to-date and in compliance with the standards of regulatory agencies.Investigate and collaborate issues within the corporation and recommend solutions concerning compliance issues.Monitor and audit employees and departments activity to ensure compliance with the existing policies.Perform patient request to amend their protected health information records by following the guidelines of the HIPAA Privacy Rule.

Ability to gown aseptically and work in a clean room (ISO 8, 7 and ISO 5) for extended periods of time.Ability to perform in process operations such as: bioreactor sampling, in process environmental monitoring, and media formulation.Knowledgeable in the use of production related IT systems such as SAP, MES and LIMS.Assist on deviation investigations and inspections, and participate in assigned qualification/ validation activities as necessary.

Assist healthcare staffs with regard to post-operative care and treatment of open heart patients.Execute dictated and written medical orders swiftly to provide immediate service and minimize risk.Serve as a liaison between staff and family members to provide information and to address questions and concerns.Responsible for acquiring essential medical equipment and supply utilized in a critical care environment.

Manage all pre-operative documents which includes history and physical, consultation, doctors orders, laboratory results, x-rays, EKG, and post operative teachings. Case volume from 50 to over 100/day.Ensure that all surgical documents are compliant to the hospital's standard.Scheduled appointments for pre operative procedures and tests.

Catalog all research documents of various consumer products for computer entry by compiling, sorting information, and establishing entry priorities. Handle over 10,000 pages/ day.Work independently, accurately and effectively handling multiple projects within a given time.Collaborate with various project teams to ensure catalog requirements are met.Review and adjust all data entry listings as needed to comply with the protocol and retention policy.

Assigned to GlaxoSmithKline

Accession of specimens for microbiology, chemistry and hematology.Assist technicians to improve work production and flow.

Prepared media plates, and inoculate live organisms used for microbiology.Prepared materials for general biology, genetics, and anatomy & physiology I & II.Prepared various chemical reagents used in general chemistry I & II, and organic chemistry I & II.Properly decontaminate and dispose of biological waste.