Quality Control Associate III
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Job Location:
Durham County, NC - USA
Monthly Salary:
Not Disclosed
Posted on:
15-10-2025
Vacancies:
1 Vacancy
Job Summary
For further inquiries regarding the following opportunity please contact one of our Talent Specialists:
Hema Malini at
Ragu at
Hema Malini at
Ragu at
Title: Quality Control Associate III
Duration: 3 Months
Location: Research Triangle Park NC
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 LabVantage is highly desirable
About us: DivIHN the IT Asset Performance Services organization provides Professional Consulting Custom Projects and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization Specialization and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race color religion (creed) gender gender expression age national origin (ancestry) disability marital status sexual orientation or military status.
Key Skills
- Computer
- IT Audit
- CAD CAM
- ABAP
- Exterior Designing
- HR Operations
