QA Specialist

CRYOPAK INC•Roanoke, VA

14d

About The Position

At Cryopak Digital (CVT), we are committed to the design and manufacturing of the most technically advanced, reliable, self-powered data loggers in the world. Our data loggers are principally used for cold chain management solutions to ensure that food, medical and pharmaceutical products are stored and transported in their required temperature conditions. Our devices are also extensively used for environmental and heating/ventilation monitoring for building management, plus energy-saving applications. Our QA Specialist is responsible for coordinating all aspects of quality and validation functions. This role includes developing, executing, and maintaining quality and validation processes to ensure that products and services comply with regulatory agency requirements, internal company standards, ISO 9001/17025 expectations, and current industry best practices. The position also supports continuous improvement initiatives by reviewing quality and validation processes and recommending enhancements in collaboration with Quality, Instrumentation, Operations, and R&D teams.

Requirements

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)

Nice To Haves

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.
Establish and maintain close communication with assigned clients to ensure superior customer satisfaction.
Ability to multi-task is essential.

Responsibilities

QA/QC inspection: 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.
Mapping services and validation: 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).