AskBio Inc. · 8 hours ago
Sr. QC Associate, Clinical Immunology
Durham, NC
Full-time
Hybrid
Senior Level
5+ years expAskBio Inc. is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The Senior Quality Control Associate, Clinical Immunology will be responsible for Quality Control activities within the Clinical Immunology functional group, ensuring compliance with local procedures and safety regulations while maintaining high-quality standards in clinical sample management.
BiopharmaBiotechnologyHealth CareManufacturingMedicalMedical Device
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
Qualification
Required
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
Preferred
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
Company
AskBio Inc.
AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives.
501-1000 employees
H1B Sponsorship
AskBio Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (4)
2022 (8)
2021 (3)
2020 (3)
Funding
Current Stage
Late StageTotal Funding
$241.76MKey Investors
Scottish Enterprise
2020-10-26Acquired
2020-09-02Grant· $2.66M
2019-04-11Private Equity· $235M
Leadership Team
S
Samuel Hopkins
Sr. Vice President, Therapeutics
Mansuo L Shannon
Board Member
Recent News
Asklepios BioPharmaceutical, Inc. (AskBio)
2025-10-21
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