Process Control Associate at ArcherDX
Invitae is dedicated to bringing comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Our team is driven to make a difference for the patients we serve. We are leading the transformation of the genetics industry by making genetic testing affordable and accessible for everyone to guide health decisions across all stages of life.
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.
- Working cross functionally between multiple groups to assist or dive NCR or CAPA with Subject Matter Experts (SME)
- 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
- Identify, drive, and document cross-functional communication for process improvement projects
- Evaluate process improvement projects to ensure documented implementation and verification of effectiveness are documented for closure
- Monitor schedules and project plans for process improvement projects and follow up on assigned tasks to functional contributors
- Document and Monitor process control metrics from Operations and Quality Control for trending analysis and remediation as needed
- Writes, reviews, and updates process control plans and risk documentation as needed
- Review, understanding, and compliance with HIPAA Security policies and procedures
- Safeguard the privacy and security of protected health information and European Union personal data
- Process and handle of European Union personal data only as directed for purposes of personalized molecular pathology
- 1-3 years of experience in a related field
- Prior work experience in a cGMP setting for operations or quality role
- Strong working knowledge of quality control principles and tools
- Good understanding of statistical modeling and data trending preferred
- Good organizational, analytical, and problem-solving skills
- Communicates clearly verbally and in writing
- Motivated self-starter, capable of achieving objectives in a demanding environment
- Detail-oriented, accurate, and highly organized
- High levels of personal integrity
- Ability to set goals consistent with company objectives and to adapt plans to a changing environment
- Bachelor’s degree in a science-related field preferred
In Colorado, our competitive compensation package includes a base salary starting from $26.45 per hour. In determining the final salary offered, we will evaluate a specific candidate's geographic location, education, skills, and experience.
Invitae offers a competitive total rewards package, which includes healthcare coverage, 401k, and a broad range of other benefits, outlined below:
- Health, dental, vision, short- and long-term disability, and basic life insurance coverage
- Paid time off, holiday pay, parental leave, and other health and wellness supports
At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.