Quality Control Associate III

For further inquiries regarding the following opportunity, please contact one of our Talent Specialists:
Hema Malini at
Ragu at

Title:
Quality Control Associate III
Duration: 3 Months

Location:

Research Triangle Park, NC

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 Lab Vantage, is highly desirable