QC Testing Inspector II

Davita Inc.; Durham (NC); On-site; USD 45,000 - 70,000; Full time

Job summary

A leading company in the Medical Devices/Diagnostics sector seeks a Quality Control Testing Inspector II in a fast-paced, FDA regulated environment. The role involves sample and material inspections, ensuring compliance with SOPs, and supporting laboratory audits. Candidates should have a High School Diploma or Bachelor's degree in a Life Science field, with experience in laboratory settings being preferred.

Qualifications

• High School Diploma with 2+ years of experience in a regulated environment or Bachelor's degree in Life Science with no prior experience.
• Prior laboratory experience preferred and knowledge of GMP documentation is advantageous.

Responsibilities

• Perform routine inspection on received materials and submitted samples.
• Maintain compliance with SOPs, GLP, GMP, and HSE requirements.
• Participate in continuous improvement activities and maintain a clean laboratory environment.

Skills

Attention to detail

Data entry

Compliance with regulations

Education

High School Diploma

Bachelor's degree in Life Science

Job description

Description

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.