Eurofins Viracor BioPharma Services · 2 weeks ago
Quality Assurance Specialist - Eurofins Environment Testing Southwest, Calscience, Tustin, CA
Tustin, CA
Full-time
Onsite
Senior Level
$26/hr - $30/hr
5+ years expEurofins Viracor BioPharma Services is part of Eurofins Scientific, a network of independent companies providing analytical testing services. The Quality Assurance Specialist is responsible for performing internal audits, assisting with external audits, and overseeing the maintenance of quality control records and standard operating procedures.
Biotechnology
No H1B
Responsibilities
Conduct group meetings
Perform data audits
Perform audits for client inquiries, etc
Assist in conducting and responding to external audits conducted by clients and regulatory agencies
Review Quality Assurance Project Plans, and technical and QC specifications in contracts and proposals
Assist in maintaining laboratory certifications
Assist in arranging and manage scheduling, ordering, login, and reporting of PT samples
Monitor new regulations and communicate them to the laboratory
Review and write SOPs
Maintain historical indices of technical records including SOPs, QC records, laboratory data, etc
Assist in and monitor laboratory’s compliance with the reference methods, SOPs, and agency-specific requirements
Maintain training records, including Demonstrations of Capability (DOCs) for all analysts
Assist in identification of systematic problems within laboratory and recommend resolutions for ongoing or recurring nonconformance
Track customer complaints and assist in identifying improvements
Oversee and review MDL studies
Generate control charts, control limits, and update LIMS
Perform or arrange for calibration of laboratory support equipment
Qualification
Required
5+ years of direct QA industry experience
Intermediate to advanced knowledge of environmental analytical methodologies
Knowledge of regulatory requirements, including TNI
Computer skills; presentations, organizing MDLs, LIMS, Excel, etc
Clear communication through language and writing
Professional demeanor
Authorization to work in the United States indefinitely without restriction or sponsorship
Professional working proficiency in English is a requirement, including the ability to read, write and speak in English
Analytical laboratory techniques
Laboratory QA requirements
Statistical principles
Technical and business writing skills
Organizational skills
Management skills
Problem solving skills
Ability to analyze problems and effect solutions
Benefits
Comprehensive medical coverage
Life and disability insurance
401(k) with company match
Paid holidays
Paid time off
Dental and vision options
Company
Eurofins Viracor BioPharma Services
Eurofins Viracor BioPharma is a trusted provider of drug development solutions to pharmaceutical and contract research organizations.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase