Quality Assurance Specialist II
Job Location:
Burlington, CO - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
The Quality Assurance (QA) Associate II supports and assists with supporting and driving the Quality and Compliance program within Broad Clinical Laboratories by contributing to the implementation maintenance and continuous improvement of the Quality Management System (QMS). This role requires a self-directed individual who can independently manage responsibilities proactively identify gaps and take initiative in advancing quality processes with moderate oversight.
This position helps ensure compliance with applicable regulatory and accreditation standards including CLIA CAP CLEP and ISO 9001 while promoting a culture of quality safety and continuous improvement.
The QA Associate partners with laboratory operations supporting next-generation sequencing (NGS) genotyping and other data generation workflows to ensure adherence to established procedures documentation practices and regulatory requirements across pre-analytical analytical and post-analytical phases of testing.
Essential Functions:
Quality Management System (QMS) Support
- Supports and sustains compliance with the Broad Quality Management System (BQMS) through independent execution of assigned activities
- Initiates document control activities including SOP formatting version control and review cycles ensuring timely progression without reliance on direct oversight.
- Ensures quality documentation is complete accurate and compliant with internal guidelines and regulatory requirements
- Participates in and proactively drives change management processes including documentation updates and tracking
- Performs user acceptance testing and documentation for change management software
Quality Assurance & Compliance Activities
- Independently monitors quality assurance (QA) and quality control (QC) activities across laboratory operations
- Supports tracking and documentation of:
- Personnel records
- Competency assessments
- Equipment maintenance and calibration records
- Proficiency testing participation and performance
- Critically reviews quality records to ensure compliance with SOPs and regulatory standards escalating risks and proposing solutions as needed
Regulatory & Accreditation Support
- Maintains working knowledge of CLIA CAP CLEP and ISO 9001 requirements
- Proactively ensures laboratory practices align with applicable regulatory and accreditation standards
- Facilitates audit readiness by independently reviewing and validating requested documentation for technical accuracy and regulatory compliance prior to external submission.
- Evaluates key performance indicators (KPIs) and quality metrics independently identifying trends and addressing compliance gaps ahead of inspections.
Quality Events (Deviations Nonconformances CAPA)
- Independently logs tracks and maintains records of deviations nonconformances and incidents
- Contributes to root cause analysis and corrective and preventive action (CAPA) documentation
- Takes ownership of assigned quality events ensuring timely progression follow-up and closure of corrective actions.
Training & Competency
- Supports maintenance of training records and training matrices
- Assists in onboarding retraining and annual competency requirements
- Ensures training documentation meets regulatory and internal standards
Quality Metrics & Continuous Improvement
- Collects analyzes and trends quality metrics (e.g. error rates compliance trends) with moderate supervision.
- Exercises independent judgment in prioritizing audit finding resolutions by identifying high risk areas that can be addressed by improvement activities.
- Leads or initiates continuous improvement efforts including Lean or Six Sigma projects from concept through implementation.
Qualifications Minimum Required Education & Experience:
- Bachelors degree in Biology Molecular Biology Chemistry Medical Technology or related scientific discipline.
- 24 years of experience in a clinical and/or research laboratory environment operating under a quality management system.
Knowledge Skills & Abilities:
- Knowledge of clinical laboratory regulatory requirements (CLIA CAP CLEP)
- Familiarity with quality systems (e.g. ISO 9001 GCLP GMP) preferred
- Understanding of laboratory workflows including pre-analytical analytical and post-analytical phases
- Strong attention to detail and organizational skills particularly in documentation and record review
- Effective written and verbal communication skills
- Ability to analyze data identify trends and independently drive problem-solving efforts
- Ability to work collaboratively in a cross-functional team environment
- Demonstrated ability to work independently manage own priorities and execute tasks with moderate supervision
- Proactive self-starter mindset with strong sense of ownership and accountability
- Ability to take initiative follow through on commitment and drive tasks to completion.
- Familiarity with document control and configuration management principles
- Experience with or ability to learn Laboratory Information Management Systems (LIMS)
- Willingness to learn and apply quality improvement methodologies (e.g. Lean Six Sigma)
Required Experience:
IC
About Company
Broad Institute is a multidisciplinary community of researchers on a mission to improve human health.
