Axela Biosciences Inc. – QA Scientist/Manager
Company:
– Biomedical service/product provider (biopharma, diagnostics, academia).
– Specializes in end-to-end support: sample collection, data analysis, IND-enabling studies.
– Location: Whippany, NJ.
Role Overview:
– Establish/oversee QA system for GLP-compliant bioanalytical lab.
– Integrate GLP & CLIA best practices (CLIA experience preferred).
– Build QA infrastructure from scratch in a fast-paced, growing organization.
Key Responsibilities:
– Design/implement GLP-compliant QA procedures, SOPs, documentation.
– Manage audits, deviations, CAPAs, change control.
– Review study protocols, raw data, reports.
– Collaborate with teams for compliance and quality improvement.
– Lead regulatory inspections/client interactions.
Technical Requirements:
– Expertise in GLP, FDA guidelines, bioanalytical QA.
– QA system implementation in regulated labs.
– CLIA/LDT validation, equipment qualification (IQ/OQ/PQ), document control.
– Proficiency in deviation tracking, root cause analysis, CAPA systems.
Soft Skills:
– Strong organizational, analytical, communication skills.
– Detail-oriented; ability to work independently/collaboratively.
Education/Experience:
– BS/MS in life sciences + 5+ years in GLP/CLIA-regulated labs.
– Experience in building QA systems (highly desirable).
Additional Info:
– Competitive compensation.
– Visa sponsorship available.
– Apply via email (info@AxelaBio.com) with position title in subject.
Key Terms: GLP, CLIA, FDA, SOPs, CAPA, LDT validation, audits.
Please email your resume to info@AxelaBio.com
