QA Technician

Cryopak-Industries; Roanoke (VA); On-site; USD 55,000 - 70,000; Full time

Benefits offered by this job

Medical Insurance

Vision Insurance

Health Savings Account (HSA)

Flexible Spending Account (FSA)

Voluntary Accident, Critical Illness,

Job summary

Cryopak Digital (CVT) in Roanoke, VA is seeking a QA/QC / Quality Assurance Specialist to perform in-production inspections, final QC checks, and support mapping validation activities. You will help maintain the QMS, write protocols, and collaborate with cross-functional teams to ensure compliance with CVT and regulatory requirements.

Your role includes CAPA logging, audit support, and ongoing quality improvements, with up to 50% travel as needed.

Qualifications

• College diploma in science, industrial pharmaceutical or related discipline (or equivalent experience).
• 1-3 years’ experience in pharmaceutical/biotechnology/QMS/quality roles (entry to intermediate).
• ISO 9001 basics: document control, non-conformity & CAPA basics, internal audits.
• ISO 17025 basics: calibration & traceability, sample handling, QC samples, test reports.
• QMS maintenance: document control, records, SOPs at basic to intermediate level.
• Quality mindset: attention to detail, proactive attitude.
• Experience writing technical protocols and reports.
• Proficient in Word and Excel; CS monitoring systems.
• Excellent organizational and prioritization skills; attention to detail.
• Valid driver’s license; travel up to 50% as needed.

Responsibilities

• QA/QC inspection: perform quality inspections at Roanoke location to meet internal quality standards.
• Mapping services: support mapping projects remotely with Montreal team and CVT roadmap.
• Inspect during production and prior to shipment; document results and deviations.
• Maintain the QMS with document control, SOP updates, and change control guidance.
• Assist in continuous improvement of QA/QC processes; suggest template and checklist updates.
• Record CAPA, track actions, and verify closure with QA Director and teams.
• Write, review protocols for mapping, validation, and quality activities.
• Coordinate mapping expectations with MTl site and clients; trend data for projects.
• Support customer communication and training on mapping activities; assist audits.

Skills

Quality mindset

Technical writing

Organization

Prioritization

Teamwork

Education

Science-related college diploma

Tools

Microsoft Word

Microsoft Excel

Computerized Monitoring System

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Full-Time Roanoke, VA, US

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.

WHAT 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
• 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
• 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.