Experience Required: At least 5 years of prior industry experience in a GxP laboratory environment. Experience in a CRO or pharmaceutical company is preferred with 1-3 years working in Quality Assurance/Quality Control. Experience in computer system validation is desirable.
Reports to: Manager of Quality Assurance
The Quality Associate is to work with the Manager of Quality Assurance and Quality Control Specialist to support the implementation and maintenance of GxP quality systems. This includes administration of controlled documents, review and creation of quality-related documents and procedures, administration and review of deviations, investigations, risk assessments and CAPAs, participate in client and internal audits, and perform Quality Control of study documents and records.
Principal Duties and Responsibilities
Act as an independent reviewer of data, processes, and documentation.
Review raw data, forms and equipment logbooks for completeness, accuracy and compliance to applicable SOPs.
Create reports on the performance of the quality system.
Collaborate with study personnel to ensure documentation review and corrections are completed to enable transfer of client deliverables on time.
Participate in client and internal audits to assure compliance with policies, procedures, and applicable regulatory requirements.
Track quality assessments within FlowMetric’s vendor management program.
Act as Document Coordinator to track version changes of controlled documents, and distribution and training of new versions.
Support the implementation of quality and continued improvement initiatives to improve operational efficiency and GxP regulatory compliance.
Use creative problem-solving skills and collaboration to improve processes that relate to GxP activities.
Knowledge, Skills and Abilities
Time management and ability to prioritize activities for greatest effectiveness.
Outstanding communication skills (including written and verbal) with ability to communicate at all levels.
Ability to manage through change and work in an innovative, fast-paced environment.
Detail oriented while able to manage multiple projects simultaneously, and strong problem solving skills with a proactive approach.
Must have a solid understanding of GLP and GxP regulations and requirements.
Able to work efficiently, independently and as part of collaborative team.
Minimum of Bachelor or Masters of Science or Arts degree in a scientifically related discipline.
FlowMetric, Inc., is a niche contract research organization (CRO), focused on providing polychromatic flow cytometry and cell sorting services to bio-pharma and drug discovery companies. FlowMetric is committed to providing independent, unbiased, comprehensive and precise test services as part of the pre-clinical and clinical trial process for its clients. FlowMetric offers integrated, cost-effective, and specialized polychromatic flow cytometry services delivered with an uncompromising commitment to quality.