Quality Control Inspector II

1 week ago


Durham, North Carolina, United States MillenniumSoft Inc Full time
Job Overview

Position: Quality Control Inspector II

Work Schedule: Monday to Friday, day shift with flexible scheduling options.

Compensation: $35 - $37 per hour.

Contract Duration: This is a one-year contract with the potential for permanent placement.

Role Summary: The Quality Control Inspector II will serve as the Lead Data Reviewer for internal studies, collaborating closely with Study Directors to ensure comprehensive and timely data evaluations across all aspects of Good Laboratory Practice (GLP) and preclinical functionality studies. This includes, but is not limited to, the review of medical records, surgical documentation, protocols, and study data.

Key Responsibilities:

  • Identify, assess, and propose solutions to findings during data review.
  • Draft study deviations promptly and incorporate assessments of impact from Study Directors.
  • Conduct audits of protocols, Standard Operating Procedures (SOPs), and quality system elements to ensure compliance with GLP regulations and internal standards.
  • Maintain adherence to internal quality guidelines and regulatory standards.
  • Detect and report instances of non-compliance with regulations and standards.

Qualifications:

The ideal candidate will possess a keen attention to detail, a background in data management, and familiarity with GLP research in the medical device sector. Collaboration across various teams and locations is essential.

Preferred Education and Experience:

  • Bachelor's degree with a minimum of three years of experience in preclinical medical device research, or five years of relevant experience supporting preclinical research.
  • Demonstrated proficiency in the use of calibrated equipment and controlled substances, as well as GLP data collection and retention.

Additional Information:

  • Employment Status: Non-Exempt
  • Job Group: 1
  • Contract-to-Hire: Yes
  • Shift: First Shift
  • Screening Requirements: N/A

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