Quality Control Associate III

DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

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

Hema Malini at

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Ragu at

(630) 847 0953

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 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.