Sonic Clinical Trials is a leading provider of central and local laboratory services supporting pharmaceutical, biotechnology and medical device clinical trials
Job Summary
Sonic Clinical Trials is a leading provider of central and local laboratory services supporting pharmaceutical, biotechnology and medical device clinical trials.
Key responsibilities include day-to-day management of key quality systems such as Non-Conformances, Complaints, Document, Risk, Audit, Archive, Change Control, Vendor Management, and Training & Compliance.
The role involves supporting local and global quality projects, liaising with referral laboratories, assisting with research into new assays/technologies, and providing input on SOPs and assay documentation.
Matching Summary
Sonic Clinical Trials is a leading provider of central and local laboratory services supporting pharmaceutical, biotechnology and medical device clinical trials.
Skills & Requirements
Must-have
Quality systems management
Non-conformances and complaints
Document, risk, audit, archive management
Laboratory quality control
Change control
Vendor management
Training and compliance
Test scoping requirements
Research new assays/technologies
SOPs and assay documentation
Harmonization activities
Nice-to-have
Support quality projects
Develop quality culture
Liaise with referral laboratories
Liaise with Systems team
Support local and global teams
Key Requirements
Tertiary qualifications
Previous quality management systems experience
Pathology laboratory or regulated laboratory experience
Experience with CAP, CLIA, NYSDOH, ISO
Strong working knowledge of GCP
Experience in a multi-skilled clinical laboratory role