QC Technician

Kapolei, HI

Job description

Title: QC Technician
Location: Kapolei, HI
Type: Full-time
Shift:Job Functions

• Support the analysis of materials, including measurement of optical, mechanical and electronic properties of raw materials and taggant product
• Use proprietary instruments to ensure quality control at various stages of production
• Ensure compliance with all associated quality procedures, control plans and quality management system requirements.
• Document inspections on pre-made inspection reports. Review and approve material and special process certifications.
• Perform analyses for process qualification to approve manufacturing set-ups.
• Provide periodic QC reports as requested
• Responsible for ensuring proper calibration of laboratory analytical equipment
• Prepare/review and maintain operation, calibration, and maintenance instruction SOPs as required for operational/compliance needs
• Possess significant knowledge of US and European regulations, with proficiency in cGMP regulatory standards and familiarity with ICH, USP, and IPEC-PQG standards
• Quality review and release of batch documents and compliance certificates for correctness of packaging components, labeling materials, distribution of samples, QA technical data, resolution of nonconforming lots, and physical release of product
• Act as the laboratory Subject Matter Expert (SME) to understand the critical aspects of laboratory instrument qualification requirements and life-cycle management, acting as a point of reference for audits
• Develop and maintain laboratory validation plan, measurement methods, and procedures, internal laboratory and vendor evaluations, and qualification of laboratory computer systems and software
• Responsible for authorizing and processing QA Holds on packaging components, labeling material and finished product when required
• Work with vendors and end users to schedule maintenance, repair and calibration events to reduce impact and downtime for laboratory operations
• Maintain quality traceability information.
• Perform routine and non-routine analytical test methods and USP testing

Skills

• Experience with optical microscopes and spectrometers
• FDA experience with medical device or other regulated industry such as food, aerospace or automotive preferred
• GMP, GCP or GLP experience in an ISO certified company preferred
• Experience with Gauge R&R a plus
• Sharp hand-eye coordination, vision and attention to details
• Lean or Six Sigma Manufacturing experience preferred
• Computer proficiency inclusive of Excel and Outlook
• Be able to interface with various computer programs that are critical to the job function
• Rely on experience and judgment to plan and accomplish goals.

Education / Experience

• Minimum Associate-level degree in science or technology is preferred.
• 1-5 years in a quality control role, particularly in a high-tech environment using optical, electrical and/or mechanical test methods
• FDA experience with pharmaceutical, medical device or other regulated industry such as food, aerospace or automotive preferred.
• GMP, GCP or GLP experience in an ISO certified company preferred

TruTag is committed to a safe work environment. All candidates will be assessed for their experience with research laboratory operations and safety precautions. Successful candidates will be required to complete TruTag’s safety training program and demonstrate understanding of the material presented prior to engaging in R&D laboratory activities.

TruTag has an established environmental, health and safety program that meets or exceeds all applicable federal, state and local laws, regulations, and requirements to which TruTag subscribes, while executing our mission. Our operations are guided by a safety and environmental policy that strives to provide a workplace free of serious, recognized hazards and we comply with these standards issued by OSHA and EPA. Compliance with environmental, health, and safety standards is a key ingredient in the training and performance reviews of all personnel. Our team includes a safety professional who creates customized training programs for our employees.