Staffing - Quality Technician III

Staffing - Quality Technician III#26-02153 Newton, NC

All On-site Job Description Equipment Qualification Technician III- Job Description Position Summary:

An Equipment Qualification Technician is responsible for ensuring that equipment used in manufacturing, laboratory, or other operational environments meets required standards of functionality, reliability, and compliance. They play a key role in validating and qualifying equipment to ensure it operates according to established specifications and regulatory requirements. ________________________________________

Key Responsibilities:

Equipment Qualification:

• Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for new and existing equipment.
• Ensure equipment meets regulatory standards (e.g., FDA, ISO, GMP, etc.) and internal quality requirements.
• Document and report qualification results, including deviations and corrective actions.
• Hands on activities to troubleshoot and resolve technical issues with newly installed equipment.
• Brainstorming with subject matter experts (SME) to do Root Cause Analysis (RCA).
• Utilize standard process improvement methodologies such as FMEA, Six Sigma, DOE, Hypothesis Tree, DMAIC, Fishbone Diagram.
• Work with trained operators to learn how to setup equipment and be trainer to train others.

Testing and Calibration:

• Conduct regular equipment testing and calibration to ensure proper functioning.
• Troubleshoot and resolve issues with equipment performance.

Documentation and Reporting:

• Prepare detailed reports documenting qualification processes, outcomes, and compliance.
• Maintain accurate and up-to-date records of all equipment qualifications and calibrations.

Compliance and Regulatory Standards:

• Ensure adherence to regulatory and industry standards such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), ISO standards, or other applicable guidelines.
• Assist in audits and inspections as needed.

Equipment Maintenance and Support:

• Collaborate with engineering, maintenance, and quality teams to ensure proper equipment care and operation.
• Provide training and technical support to staff using qualified equipment.

Continuous Improvement:

• Identify opportunities to improve equipment qualification processes and implement best practices.
• Stay updated on changes to regulatory standards and industry advancements.

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Qualifications:

Education:

• Associate's or bachelor's degree in engineering, science, or a related technical field.

Relevant certifications may be considered.

Experience:

• 1-3 years of experience in equipment qualification or a related role.

Technical Skills:

• Knowledge of equipment qualification protocols (IQ, OQ, PQ).
• Familiarity with regulatory requirements (e.g., ISO, OSHA)
• Proficiency with diagnostic tools and calibration equipment.
• Industrial equipment operation and troubleshooting.

Soft Skills:

• Strong analytical and problem-solving skills.
• Excellent written and verbal communication.
• Attention to detail and ability to follow procedures precisely.

Other Requirements:

• Ability to work independently and as part of a team.
• Willingness to travel to different sites when necessary.
• Physical ability to handle equipment and perform inspections.

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Work Environment:

• May involve working in laboratories, manufacturing facilities, or cleanroom environments.
• Requires adherence to safety protocols and use of personal protective equipment (PPE) as needed.
• This role is critical for ensuring equipment reliability and regulatory compliance, supporting the success and integrity of operational processes.

Disclaimer:

The first 4-6 weeks of assignment will be training on the floor in shifts, 7 AM to 7 PM. After training is complete, assignment will be

M-F:

8-5. However, occasional overtime and after-hours support can be expected to make required progress of the project. This is the pay range that Magnit reasonably expects to pay someone for this position, however, as a supplier your expected pay range may differ:

• /hr.-
• /hr.

Benefits:

It is recommended that employers include a general description of any health or compulsory benefits for compliance with Pay Transparency laws.

EEO:

"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."