Process Control Associate (ADX-332-20)
Process Control Associate (ADX-332-20)
COMPANY SUMMARY:
In October 2020, Invitae Corporation (NYSE: NVTA) combined with ArcherDX, a genomic analysis company specializing in cancer diagnostics and monitoring, to create a leading comprehensive medical and cancer genetics company. As a combined company, Invitae, is bringing world-class genetic testing and diagnostics into mainstream medicine to improve healthcare for billions of people. Our goal is to aggregate the world’s genetic tests into a single service with higher quality and accuracy, faster turnaround time and actionable results. Learn more at invitae.com and archerdx.com.
POSITION SUMMARY:
The Process Control Associate ensures appropriate documentation and record keeping is followed as part of operating and maintaining system controls. System controls may be related to Non-Conformance Report (NCR) execution and tracking, Corrective or Preventative Action (CAPA) execution and planning, statistical monitoring of operational outputs, or implementation of system improvements through engineering change orders (ECO). This position helps to operate, maintain, or create appropriate system controls to continue to develop business practices in accordance with quality and company initiatives.
RESPONSIBILITIES:
Work with management and SME’s to implement execution plans for assigned NCRs and CAPAs to conduct in prescribed timelines. May include root cause analysis, containment activities, and verification of effectiveness
Evaluate process improvement projects to ensure documented implementation and verification of effectiveness are documented for closure
Document and Monitor process control metrics from Operations and Quality Control for trending analysis and remediation as needed
Review, understanding, and compliance with HIPAA Security policies and procedures
Process and handle of European Union personal data only as directed for purposes of personalized molecular pathology
EXPERIENCE:
Prior work experience in a cGMP setting for operations or quality role
KEY ATTRIBUTES:
Good understanding of statistical modeling and data trending preferred
Communicates clearly verbally and in writing
Detail-oriented, accurate, and highly organized
Ability to set goals consistent with company objectives and to adapt plans to a changing environment
EDUCATION:
- Bachelor’s degree in a science-related field preferred