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Pharmaceutical - Quality Assurance

Integrated Resources, Inc

San Diego, California

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JOB DETAILS
JOB TYPE
Contractor
SKILLS
Adobe Acrobat, Assays, Biology, Biomarkers, Biotech and Pharmaceutical, Calibration, Change Control, Clinical Laboratory, Clinical Research, Clinical Support, Clinical Trial, Corrective Action, Document Management, Documentation, External Audit, GCP (Good Clinical Practices), Identify Issues, Instrumentation, Internal Audit, Laboratory Techniques, Maintain Compliance, Microsoft Office, Molecular Analysis, Molecular Biology, Oncology, Pharmacy, Presentation/Verbal Skills, Process Management, Quality Assurance, Quality Assurance Methodology, Quality Management, Regulations, Regulatory Compliance, Research Laboratory, Safety Process, Standard Operating Procedures (SOP), Validation Plan
LOCATION
San Diego, California
POSTED
1 day ago
Pharmaceutical - Quality AssuranceJob Description: The individual in this position is responsible for performing day-to-day quality assurance (QA) activities, managing QA processes such as document management, internal audits, instrumentation change control, corrective and preventative actions, and assay validation planning to ensure compliance to GCLP requirements as the Client Oncology Clinical Research Laboratory (POCRL) develops, validates, and performs clinical trial assays. In addition, the position is responsible for providing QA support for clinical trial assay activities, including receipt, accessioning, and internal tracking of clinical trial biospecimens.RESPONSIBILITIES:Maintain, troubleshoot, and monitor the effectiveness of the POCRL's Quality Management System (QMS)Ensure that POCRL activities conform with the requirements of the laboratory QMSCoordinate creation, approval, implementation, and periodic reviews of Client Standard Operating Procedures for the POCRL according to GCLP guidelinesReview and approve new assay validation plans and reports according to GCLP guidelines with reference to CAP/CLIA regulations for molecular assay validationDraft, review and approve continuing quality improvement documentationMaintain laboratory QMS documentation in Client's document management systemConduct annual QA audits of the POCRL & clinical trial assay processes, document findings, compose and execute Corrective and Preventative Action Plans as appropriateCoordinate external QA audits as required and advise laboratory director of appropriate corrective actionsServe as the POCRL's point of contact with clinical Biomarker Assay Specialist groups within early- and late-clinical developmentEnsure that the maintenance/calibration status of POCRL equipment is monitored and currentTECHNICAL SKILLS:Ability to create and enforce laboratory standard operating proceduresKnowledge of molecular biology and laboratory safety procedures for handling hazardous chemicals and biosafety level 2 biohazard materialsKnowledge of standard molecular biology laboratory equipmentExcellent written and verbal communication skillsAbility to work independentlyAbility to interface with clinical research teamsProficiency with standard office software (Microsoft Office, Adobe Acrobat)What is the minimum education experience required?: BS/MS in a biological science, pharmacy, medical technology, or a related field. Medical Technology, MT (ASCP) license or equivalent (preferred). At least 2 years' experience working in a laboratory setting that included a QMS. Good working knowledge of GCP/GCLP guidelines. Experience working in a GCP/GCLP environment (preferred)All your information will be kept confidential according to EEO guidelines.

About the Company

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Integrated Resources, Inc