Senior Quality Assurance Specialist
About The Position
ATCC is hiring a Senior Quality Assurance Specialist to support its Compliance & Quality Assurance function onsite in Manassas, Virginia. The role maintains and improves quality processes and helps ensure adherence to internal and external standards. It identifies nonconformities and risks, conducts root cause analysis, and supports corrective and preventive actions (CAPA). The specialist works across departments on quality systems, customer complaint processing, document control, audits, risk assessments, training, metrics, and continuous improvement. The position supports the global scientific community by helping ensure the quality and compliance of ATCC’s biological materials and related processes.
Requirements
- Bachelor's degree and 5 years of experience, or equivalent experience: Ph.D., Master's degree and 3 years of experience, or high school diploma and 9 years of experience.
- Experience applying quality standards and supporting quality assurance systems, internal controls, risk management, and regulatory compliance.
- Experience with nonconformities, corrective and preventive actions (CAPA), root cause analysis, customer complaint processing, audits, and risk assessments.
- Knowledge of SOPs, controlled documentation, document control, change control, records management, and quality-related information technology systems.
- Ability to analyze quality metrics, evaluate process effectiveness, support continuous improvement initiatives, and apply judgment to diverse quality issues.
- Experience developing quality assurance training, mentoring staff, advising internal customers, and leading cross-functional process improvement activities.
Responsibilities
- Apply relevant quality standards, evaluate industry changes, and support quality assurance processes that maintain compliance with internal and external requirements.
- Identify nonconformities and risks, conduct root cause analysis, and work with internal departments to develop remedies, corrective actions, and preventive actions.
- Support customer complaint processing.
- Support controlled documents, SOPs, change control, records retention, storage, archiving, and disposal using established document control practices and information technology systems.
- Schedule, plan, lead, or participate in internal and vendor audits and risk assessments.
- Prepare audit reports and support resolution and monitoring of identified actions.
- Analyze quality assurance metrics, present findings for management review, and identify trends in quality concerns.
- Work cross-functionally to support process improvement plans and resulting actions.
- Develop quality assurance training, mentor staff, advise internal customers, and lead cross-functional process improvement activities.
Benefits
- Comprehensive medical coverage
- Company-paid life insurance
- Disability insurance
- AD&D coverage
- Paid parental leave
- Paid holidays and PTO
- Fitness and cell phone subsidies
- Legal services
- Pet insurance
- Additional supplemental coverage
- Employee Assistance Program offering around-the-clock counseling
- 401(a) retirement plan with a 6% employer contribution
- 403(b) retirement plan with a 2% match
- Career advancement opportunities, recognition, and rewards
- Corporate bonus program
- Regular merit increases
- Additional incentive compensation may be available
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What This Job Offers
Job Type
Full-time
Career Level
Senior
