Labcorp, a leading global life sciences company, is dedicated to advancing healthcare and improving lives. With a steadfast commitment to innovation and excellence, Labcorp leverages its extensive expertise in diagnostics and drug development to address the world’s most pressing health challenges. As an Equal Opportunity Employer, Labcorp fosters a diverse and inclusive workplace, ensuring every team member thrives and contributes to the company’s mission.
Responsibilities in Job
As a Contingent Worker in Administrative Services at Labcorp, you will:
- Conduct comprehensive computer systems validation and instrument validation.
- Ensure compliance with regulatory standards such as 21 CFR Part 11, EU Annex 11, OECD 17, MHRA Data Integrity Guidance, and OECD 22.
- Apply ALCOA+ principles to ensure data integrity.
- Utilize the Software Development Life Cycle (SDLC) methodology to manage projects effectively.
- Implement and uphold GAMP5 guidelines in all validation processes.
- Perform risk assessments using Failure Mode and Effects Analysis (FMEA).
- Prepare and maintain thorough documentation to support validation activities.
- Collaborate with cross-functional teams to enhance system performance and compliance.
Qualifications
To excel in this role, candidates should possess:
- A Bachelor’s degree in Engineering or a scientific discipline such as Pharmacy, Biologics, Computer Science & Engineering, or Instrumentation.
- A minimum of 4 years of relevant experience in computer systems validation and/or instrument validation.
Key Skills
- In-depth understanding of 21 CFR Part 11, EU Annex 11, and related regulatory standards.
- Proficiency in applying SDLC methodologies and GAMP5 guidelines.
- Expertise in risk-based validation techniques and FMEA analysis.
- Strong command of English with excellent written and verbal communication skills.
- Proficiency in Microsoft Word and Excel.
