QA Technician

Cryopak; Roanoke (VA); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Health Savings Account (HSA)

Flexible Spending Account (FSA)

Life Insurance

Disability Insurance

401(k)

Job summary

Cryopak Digital (CVT) seeks a QA/QC professional to join our Roanoke team. You will perform quality inspections on data loggers and calibration services, help advance QA/QC mappings, and maintain documentation for ISO and internal standards. Collaboration with Montreal staff and continuous improvement are emphasized.

The role requires 1–3 years in pharma/biotech/QMS, strong writing skills, and proficiency with Word/Excel. Travel up to 50% is possible depending on project needs.

Qualifications

• 1-3 years’ experience in pharmaceutical/biotechnology/QMS or quality roles.
• Strong written communication and documentation skills.
• Familiar with ISO 9001 and ISO 17025 basics and CAPA processes.

Responsibilities

• Perform QA/QC inspections at the Roanoke location to ensure products meet standards.
• Support mapping services remotely and collaborate with the Montreal QC team.
• Document inspection results and report deviations promptly.
• Assist in maintaining the QMS, SOP updates, and change controls.
• Support audits and CAPA tracking with the QA Director.

Skills

Quality mindset

Attention to detail

Technical writing

Organizational skills

Communication

Teamwork

Education

College diploma in science, industrial pharmaceutical or related discipline

Tools

Microsoft Word

Excel

Computerized Monitoring System

Job description

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.

HOW YOU WILL CONTRIBUTE (Overview & Key Responsibilities)

• Location Specific Responsibilities:
• QA/QC inspection: Perform and support quality inspections at the CDI Roanoke location to ensure products (data loggers, devices, calibration services) meet internal quality standards.
• Mapping services & validation: Collaborate with the Quality Director and the QC/Validation Specialist (Montreal site) to support mapping services remotely and help advance mapping projects on the roadmap.
• QC/QA Inspection During Production and Prior to Shipment:
• Perform quality inspections during production to ensure products meet internal and customer requirements.
• Conduct final QC/QA inspections for orders shipped to customers (data loggers, devices, calibration services).
• Document inspection results and report deviations or nonconformities in a timely manner.
• Quality System Improvements
• Assist in maintaining the QMS by supporting document control (version management, approval workflows, and archiving), SOP updates, and change control processes under the guidance of the QA Director.
• Identify and assist in implementing improvements to QA/QC processes by recognizing inefficiencies, suggesting practical solutions (e.g., template revisions, checklist updates), and collaborating with the QA team on continuous improvement initiatives.
• Maintain familiarity with laboratory operations and QA/QC procedures by actively reviewing relevant SOPs, observing routine lab activities, and staying informed of any changes to equipment, methods, or regulatory expectations.
• Testing and Anomaly Management:
• Execute testing plans and procedures as directed, recording all results accurately.
• Report any non-conformance (deviation from specifications, procedures, or acceptance criteria) to the QA Director and follow up on corrections with Operations and Lab teams.
• Document CAPA by logging records, tracking action items, and gathering evidence of implementation under the guidance of the QA Director
• Mapping Service & Quality Documentation
• Assist in writing, executing, and reviewing protocols for mapping, validation, and quality activities.
• Apply basic to intermediate judgment to support approval criteria and solutions aligned with CVT and regulatory requirements.
• Help ensure project timelines are met.
• Coordinate mapping project expectations with the QC/Validation Specialist (MTL site) and clients.
• Collect and assist in trending data for mapping/validation projects.
• Collect and data trend reviews of mapping /validation projects.
• Training, Customer Support, and Cross-Functional Coordination:
• Support customer communication regarding mapping services.
• Assist in training customer staff on basic mapping/validation activities.
• Participate in internal training on compliance topics.
• Work cross-functionally with other teams as needed.
• Audit Support
• Support the QA Director / Operations Manager during customer and ISO audits by providing documentation as requested.
• Help with audit readiness and follow-up on corrective actions.
• Participate in internal audits and assist with CAPA implementation and verification

WHAT YOU NEED TO SUCCEED (Qualifications)

• College diploma in science, industrial pharmaceutical or related discipline (or equivalent experience).
• 1-3 years’ experience in pharmaceutical /biotechnology /QMS / or quality-related roles (entry-level to intermediate)
• Advanced level communication required for technical writing, customer communication, and documentation).
• ISO 9001 &– Basic to Intermediate: document control, non-conformity & CAPA basics, internal audit participation, continuous improvement.
• ISO 17025 &– Basic to Intermediate: equipment calibration & traceability, sample handling, quality control (QC) samples, test report accuracy, personnel competence records.
• QMS Maintenance: Ability to help maintain the QMS (document control, records, SOPs) at a basic to intermediate level
• Quality Mindset: Attention to detail, willingness to learn, proactive attitude.
• Experience writing technical protocols and reports.
• 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).

WHAT WILL SET YOU APART (Required Competencies)

• 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 work in a team environment

Why Join Us

We strive to offer a comprehensive benefits package that helps you and your family maintain health and well-being -both physically and financially. Our comprehensive benefits package includes:

• 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

It is our policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.