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QA TechnicianTCP Reliable Manufacturing, Inc. • United States
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QA Technician

TCP Reliable Manufacturing, Inc.
  • US
    United States
  • US
    United States
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Über

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):
Our QA Technician supports quality and validation functions. This role requires basic to intermediate knowledge of quality principles including ISO 9001 (Quality Management Systems) and ISO 17025 (Testing and Calibration Laboratories). The QA Technician must be capable of maintaining the Quality Management System (QMS) and demonstrate a strong quality mindset. Extensive ISO expertise is not required - only a solid, working understanding of quality concepts.
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.
  • United States

Sprachkenntnisse

  • English
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