LeadStack
Job Details
LeadStack Inc. is an award-winning, one of the nation's fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce. As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, we're proud to partner with some of the most admired Fortune 500 brands in the world.
Job Title: Quality Control Associate III Duration: 3 months Location: Research Triangle Park, NC - 27709 PR: $30 to $35/hr Position Overview The Quality Control Associate, Translational Medicine reporting to a Director/Senior Director within Translational Medicine, will be responsible for Quality Control activities within the Translational Medicine group at the Discovery 1 laboratory located in RTP. This position will be responsible for building and maintaining Quality Control practices in compliance with local procedures and safety regulations.
Responsibilities
Review documentation for pre-clinical and clinical samples received, processed, and biobanked using LIMS and controlled documents according to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available).
Review documentation of outgoing and incoming sample shipments, including sample inventory reconciliation according to ALCOA+ principles.
Perform thorough peer review according to ALCOA+ principles to ensure accuracy of raw data, calculations, and trends of technical data generated by the bioanalytical group including biodistribution, viral shedding, and biomarker activities.
Perform thorough peer review to ensure accuracy of raw data, calculations, and trends of technical data generated by ddPCR, RT-ddPCR, ligand binding assays, and other relevant modalities.
QC review of assay qualification/ validation plans, data and reports.
QC review of regular electronic data uploads to data management portals.
Conduct internal audits of studies, reports, records, and data to ensure compliance.
Detect Quality Issues and support appropriate corrective and preventative actions.
Assist with improvement initiatives intended to improve quality, study compliance, project data, and reports.
Contribute to the development, implementation, and maintenance of Standard Operating Procedures.
Support the coordination and management of regulatory agency inspections, parent company audits, etc.
Assist with sample receipt, management, and associated documentation.
Participate in meetings as a quality control representative as requested.
QC additional lab operations for compliance with GLP/GcLP compliance (e.g. equipment and reagent logbooks).
Manage corrective and preventative action (CAPA) process and lead continuous improvement activities.
Assist with training of Translational Medicine staff on aspects of the Quality Management System and regulations that are relevant to their role.
Maintain a close liaison with Quality Assurance and relevant parties within Translational Medicine to facilitate support of critical activities.
Strictly adhere to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents, both internal and external.
Partner with laboratory staff to create efficient processes for documentation and data flow.
Required Education and Experience
Bachelors in a relevant scientific field and 3-5 years of work experience or Masters and 1-2 years of relevant work experience, or 7-9 years of relevant work experience.
3-5 years' QC experience in a GLP/GCLP laboratory within the pharmaceutical or biotech industry or related field.
Minimum of one year of experience writing SOP in a research environment.
Previous experience with ddPCR, RT-ddPCR, and ligand binding assays is highly desirable.
Knowledge of industry best practices and regulatory requirements (Good Clinical Laboratory Practice, Good Laboratory Practice, Good Clinical Practices, CLIA and a solid understanding of Good Documentation Practice, 21 CFR Part 11, and laboratory standards relevant to clinical and preclinical laboratory research.
Strong collaborative skills. Must be able to effectively collaborate cross-functionally with peers, scientific and technical staff; and be comfortable working in a matrixed team.
Preferred Experience and Skills
Ability to handle multiple projects/teams simultaneously.
Ability to work independently in a fast-paced, highly interactive environment with minimal supervision.
Excellent verbal and written communication skills.
Ability to build open and collaborative relationships and work effectively as a member of a multi-disciplinary team.
Excellent self-organization skills with ability to envisage/design/implement organizational systems to improve efficiency and function of working teams.
Experience with LIMS systems, especially LabVantage, is highly desirable.
Thanks and Regards Sharif Khan Senior Recruiter C. (415) 868-6741 A. 611 Gateway Blvd, Ste 120 South San Francisco, CA 94080 W. https://www.leadstackinc.com
#J-18808-Ljbffr
Job Title: Quality Control Associate III Duration: 3 months Location: Research Triangle Park, NC - 27709 PR: $30 to $35/hr Position Overview The Quality Control Associate, Translational Medicine reporting to a Director/Senior Director within Translational Medicine, will be responsible for Quality Control activities within the Translational Medicine group at the Discovery 1 laboratory located in RTP. This position will be responsible for building and maintaining Quality Control practices in compliance with local procedures and safety regulations.
Responsibilities
Review documentation for pre-clinical and clinical samples received, processed, and biobanked using LIMS and controlled documents according to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available).
Review documentation of outgoing and incoming sample shipments, including sample inventory reconciliation according to ALCOA+ principles.
Perform thorough peer review according to ALCOA+ principles to ensure accuracy of raw data, calculations, and trends of technical data generated by the bioanalytical group including biodistribution, viral shedding, and biomarker activities.
Perform thorough peer review to ensure accuracy of raw data, calculations, and trends of technical data generated by ddPCR, RT-ddPCR, ligand binding assays, and other relevant modalities.
QC review of assay qualification/ validation plans, data and reports.
QC review of regular electronic data uploads to data management portals.
Conduct internal audits of studies, reports, records, and data to ensure compliance.
Detect Quality Issues and support appropriate corrective and preventative actions.
Assist with improvement initiatives intended to improve quality, study compliance, project data, and reports.
Contribute to the development, implementation, and maintenance of Standard Operating Procedures.
Support the coordination and management of regulatory agency inspections, parent company audits, etc.
Assist with sample receipt, management, and associated documentation.
Participate in meetings as a quality control representative as requested.
QC additional lab operations for compliance with GLP/GcLP compliance (e.g. equipment and reagent logbooks).
Manage corrective and preventative action (CAPA) process and lead continuous improvement activities.
Assist with training of Translational Medicine staff on aspects of the Quality Management System and regulations that are relevant to their role.
Maintain a close liaison with Quality Assurance and relevant parties within Translational Medicine to facilitate support of critical activities.
Strictly adhere to all applicable written Standard Operating Procedures (SOPs), company policies, and technical guidance documents, both internal and external.
Partner with laboratory staff to create efficient processes for documentation and data flow.
Required Education and Experience
Bachelors in a relevant scientific field and 3-5 years of work experience or Masters and 1-2 years of relevant work experience, or 7-9 years of relevant work experience.
3-5 years' QC experience in a GLP/GCLP laboratory within the pharmaceutical or biotech industry or related field.
Minimum of one year of experience writing SOP in a research environment.
Previous experience with ddPCR, RT-ddPCR, and ligand binding assays is highly desirable.
Knowledge of industry best practices and regulatory requirements (Good Clinical Laboratory Practice, Good Laboratory Practice, Good Clinical Practices, CLIA and a solid understanding of Good Documentation Practice, 21 CFR Part 11, and laboratory standards relevant to clinical and preclinical laboratory research.
Strong collaborative skills. Must be able to effectively collaborate cross-functionally with peers, scientific and technical staff; and be comfortable working in a matrixed team.
Preferred Experience and Skills
Ability to handle multiple projects/teams simultaneously.
Ability to work independently in a fast-paced, highly interactive environment with minimal supervision.
Excellent verbal and written communication skills.
Ability to build open and collaborative relationships and work effectively as a member of a multi-disciplinary team.
Excellent self-organization skills with ability to envisage/design/implement organizational systems to improve efficiency and function of working teams.
Experience with LIMS systems, especially LabVantage, is highly desirable.
Thanks and Regards Sharif Khan Senior Recruiter C. (415) 868-6741 A. 611 Gateway Blvd, Ste 120 South San Francisco, CA 94080 W. https://www.leadstackinc.com
#J-18808-Ljbffr