Cryopak · 19 hours ago
QA Specialist
Roanoke, VA
Full-time
Onsite
Mid Level
3+ years expCryopak is committed to the design and manufacturing of advanced data loggers for cold chain management solutions. The QA Specialist will coordinate quality and validation functions, ensuring compliance with regulatory requirements and internal standards while supporting continuous improvement initiatives.
ManufacturingProduct DesignSupply Chain Management
Responsibilities
Perform and reinforce quality inspections at the CVT Roanoke location to ensure all products, including data loggers, devices, and calibration services, meet internal quality standards and regulatory requirements
Collaborate closely with the Quality Director and the QC/Validation Specialist at the Montreal site to support mapping services remotely under the MTL account, advance all mapping projects on the roadmap, and ensure alignment and consistency across sites
Write /execute / reviews (protocol generation, execution, and final package preparation) process Mapping /validation/quality activities related to the implementation of process changes and new processes
Apply sound judgment to establish approval criteria and implement solutions aligned with CVT and regulatory requirements
Ensure that agreed section and project timelines are implemented and achieved
Ensure project and section timelines are met and activities adhere to applicable guidelines and standards
Co-ordination the mapping /Thermal equipment’s/ system validation project expectations with QC/Validation Specialist (located at CDI MTL site) and CVT Pharma clients
Collect and data trend reviews of mapping /validation projects
Reinforce quality inspection activities throughout production to ensure products, components, and calibration services meet internal quality standards and customer requirements
Perform final QC/QA inspections for all orders shipped to customers, including data loggers, devices, and calibration services, to confirm compliance with specifications and regulatory expectations
Document all inspection results during production and prior to shipment, and report any deviations, nonconformities, or required corrective actions (CAPA) in a timely and accurate manner
Identify, implement, and review improvements to QA/QC processes (policies, change control, SOPs, technical documentation) supporting regulatory, instrumentation, and R&D activities
Maintain familiarity with laboratory operations, QA/QC procedures, quality system regulations, and standards to support both the Operations, R&D and Quality departments
Create and execute testing plans and procedures according to the most appropriate methodology, report anomalies and follow their corrections with the R&D team
Create and prioritize bug reports with clear reproduction steps
Conduct team meetings and follow up with customers regarding mapping services to ensure clarity, alignment, and continuity of service
Provide training to customer staff on mapping and validation activities to ensure they receive the appropriate level of support needed to meet project requirements
Deliver internal employee training on compliance-related topics, policies, and procedures to support overall quality and operational excellence
Work cross-functionally with other departments or teams and attend meetings as required to support quality and validation activities
Support the QA Director / Operations Manager during customer audits and ISO/regulatory inspections by providing requested documentation, process explanations, and evidence of compliance
Collaborate with internal teams to ensure audit readiness and follow up on audit observations, corrective actions, and required improvements
Participate in and support internal audits by preparing documentation, conducting audit activities as assigned, and contributing to the implementation and verification of corrective and preventive actions (CAPA)
Qualification
Required
College diploma in science, industrial pharmacy or related discipline
3+ years' experience in pharmaceutical /biotechnology / QMS / Technical Operations / Quality Experience (e.g. Quality Assurance / Quality Control/Validation)
Advanced level communication required for technical writing, customer communication, and documentation
Knowledge of GMPs guidelines, and process QA/QC/Validation
Experience writing technical protocols and reports
Experience raising, completing, and investigating quality records (e.g., deviations, nonconformities, CAPA)
Proficient in Microsoft Word and Excel & Computerized Monitoring System
Excellent organizational and prioritization skills and methodical attention to detail
Understanding of accessibility and usability best practices
Valid driver's license: ability to travel up to 50% (as needed)
Organizational skills
Excellent verbal communication and technical writing skills with strong attention to detail
Ability to effectively prioritize and execute tasks in a high-pressure environment
Establish and maintain close communication with assigned clients to ensure superior customer satisfaction
Ability to multi-task is essential
Benefits
Medical Insurance
Dental Insurance
Vision Insurance
Health Savings Account (HSA)
Flexible Spending Account (FSA)
Voluntary Accident, Critical Illness, and Hospital Indemnity Insurance
Basic Life and AD&D / Voluntary Life and AD&D
Short-Term Disability
Long-Term Disability
Pet Insurance
Commuter Transit Benefits
401(k) Retirement Plan w/Safe Harbor Employer Contribution
Paid Holidays
PTO
Company
Cryopak
Cryopak is a production company that focuses on designing and manufacturing self-powered data loggers for various industries. It is a sub-organization of Integreon Global.
201-500 employees
Funding
Current Stage
Growth StageRecent News
2025-11-10
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