QC Testing Inspector II

1 Month ago • 2 Years +

Job Summary

Job Description

This position is in a fast-paced, FDA regulated environment within the Medical Devices/Diagnostics Industry. The Quality Control Testing Inspector II is a key role, facilitating sample and material inspection, result review and communication, and testing continuity. They perform routine inspection on materials received and samples submitted to Quality Control laboratories, and verify the results and communication of testing. Responsibilities include ensuring accurate and timely inspection, reviewing documentation in compliance with SOPs, maintaining compliance with regulations, preparing for audits, and providing input for laboratory investigations. The role also involves data entry into LIMS, maintaining training, and utilizing PPE, participating in continuous improvement activities, and maintaining a clean and organized lab environment.

Must have:

Ensure accurate and timely inspection and documentation.
Review Quality Control documentation in compliance with SOPs.
Maintain compliance with SOPs, GLP, GMP, and HSE requirements.
Enter data into LIMS and applicable data sheets.
Utilize PPE as required for routine and non-routine duties.
Participate in continuous improvement activities.
Maintain the laboratory in a well-organized manner.

Good to have:

Prior laboratory experience
Experience with GMP documentation

3 skills required

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Job Details

Position Summary & Responsibilities:

This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The Quality Control Testing Inspector II will be in a key position in the Quality Control department by facilitating sample and material inspection, result review and communication, and testing continuity. Perform routine inspection on material received and samples submitted to Quality Control laboratories, and verify the results and communication of testing.

Quality
- Ensures all inspection and documentation is completed in an accurate, thorough, and timely manner.
- Ensures review of Quality Control documentation is done in compliance with SOPs and is completed in an accurate and timely manner.
- Maintains compliance with SOPs, GLP, GMP, and HSE requirements.
- Prepares for regulatory, customer, and internal audits of Quality Control areas.
- Preparation includes review of logbooks, material expirations, component storage, etc.
- Provides input for laboratory investigations.
Documentation/Training
- Enters data into the laboratory information management system (LIMS) and applicable paper-based data sheets. Assists with LIMS data entry to support LIMS maintenance and validation activities.
- Ensures personal training is maintained to current department processes and procedures.
Safety
- Appropriately utilizes PPE (Personal Protective Equipment) as required to perform routine and non-routine duties.
Continuous Improvement
- Participate in continuous improvement activities.
- 6S: Maintain the laboratory and other specific testing areas of responsibility in a well-organized, clean, and tidy manner in compliance with cGLP.
Other Duties
Performs additional job-related duties as assigned by management.

Education, Skills, & Experience:

High School Diploma with 2+ years of experience working in a laboratory or regulated environment, GMP preferred
Bachelor's degree with 0 years of relevant experience also accepted. Degree in a Life Science field preferred.
Prior laboratory experience preferred.
Experience with GMP documentation preferred.

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