Sr. QC Associate, Clinical Immunology

Asklepios BioPharmaceutical, Inc. (AskBio)•Durham, NC

53d

About The Position

The Senior Quality Control Associate, Clinical Immunology reporting to a Sr. Director within Clinical Immunology, will be responsible for Quality Control activities within the Clinical Immunology functional group at both the Discovery 1 laboratory located in RTP and the laboratory at the Philadelphia site. This position will be responsible for building and maintaining Quality Control practices in compliance with local procedures and safety regulations.

Requirements

Bachelors in a relevant scientific field and 5 years of work experience or Masters and 2 years of relevant work experience, or 9 years of relevant work experience
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 antibody and/or cell-based assays: NAb/TAb/ELISPOT 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

Nice To Haves

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

Responsibilities

Review documentation of all 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 trending on technical data generated by the antibody assay team including NAb and TAb assays.
Perform thorough peer review to ensure accuracy of raw data, calculations, and trending on technical data generated by the ELISPOT team at both RTP and Philadelphia locations.
QC review of assay qualification/ validation plans, data and reports according to ALCOA+ principles.
QC review of regular electronic data uploads to data management portals.
Conduct internal audits of studies, reports, records, and data to ensure compliance with ALCOA+.
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.
Participate in meetings as a quality control representative as requested.
Ensure the specified laboratory at Discovery 1 is in compliance with CLIA regulations.
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 CI staff on aspects of the Quality Management System and regulations that are relevant to their role.
Maintain a close liaison with Quality Assurance to facilitate their support of Clinical Immunology activities.
Travel regularly between Philadelphia and RTP sites as needed to perform direct oversight of physical processes such as paper documentation and laboratory equipment.
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