QA Auditor IV

SIN Labcorp Development (Asia) Pte. Ltd.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Labcorp is seeking a QA Auditor in Singapore to support regulatory compliance, audits, and quality program improvements. You will lead internal facility and process inspections, review audit data, and report trends to management.

The ideal candidate holds a Bachelor’s Degree in Life Sciences, at least 3 years in a regulatory environment, and solid knowledge of industry quality systems. Strong communication and analytical skills are essential.

Qualifications

• Bachelor’s Degree in Life Sciences or equivalent Life Science experience.
• 3 years in a regulatory environment (Experienced GxP auditor).
• Knowledge of industry quality systems/standards and able to apply regulations to monitor compliance.

Responsibilities

• Conduct protocol/data review for specific study types.
• Lead internal facility/process inspections.
• Evaluate responses to inspection reports and ensure resolution.
• Report on relevant quality metrics and trends.

Skills

GxP auditing

Regulatory compliance

Quality systems knowledge

Clear communication

Education

Bachelor’s Degree in Life Sciences

Job description

Labcorp is a global leader in laboratory services, providing the insights and answers that help healthcare providers, patients, researchers, pharmaceutical companies and health systems make confident decisions and improve outcomes. Through our unparalleled science, data, technology and laboratory network, we advance diagnostics, accelerate innovation and help address some of the world’s most important health challenges. As we shape the future of healthcare, we are leveraging advanced technologies, intelligent digital solutions and data-driven innovation across our operations to enhance how work gets done and deliver greater value to customers and patients. With our global scale and deep expertise, you’ll have the opportunity to do meaningful work, grow your career and make a real impact on people’s health around the world. Together, we’re improving health and improving lives.

Job Responsibilities:

• Conduct, but not limited to protocol, data/report review, where applicable for specific study types
• Lead internal facility/process inspections
• Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution
• Report on relevant quality metrics and highlight trends
• Provide consultation to the operational team
• Delivery of training in performance of audits
• Work with operational management to support Quality topics and/or working on projects with QA team on other sites
• Contribute to local Quality initiatives and process improvement initiatives aimed at improving compliance and/or efficiency of the local QA organization
• Create and/or re-write QA SOPs based on findings from local quality initiatives
• Organizing, Prioritizing and Managing all aspects of workload to meet business needs
• Ensure Regulatory Compliance and Quality Assurance responsibilities, as indicated in applicable controlled documents, are followed
• Other duties as assigned by management

Minimum Qualifications:

• Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)
• 3 years in a regulatory environment (Experienced GxP auditor)
• Knowledge of industry quality systems/standards and able to apply (applicable) regulations to monitor compliance

Preferred Qualifications:

• At least 2 or more years of QA experience
• Experience may be substituted for education
• Ability to apply basic relevant regulatory knowledge
• Ability to follow instruction e.g. QA documents (SOPs)
• Ability to assimilate/interpret operational documents such that audit can be performed to required level

Additional Job Standards:

• Experienced in process improvement
• Demonstrated ability to apply critical thinking skills
• Clear communication skills, including ability to provide clear feedback
• Able to clearly articulate processes to provide training
• Able to influence process improvement initiatives and offer solutions

Labcorp is proud to be an Equal Opportunity Employer: Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.

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We believe in the power of science to change lives. Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers, and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. Here, you can join our nearly 70,000 employees, serving clients in more than 100 countries, as we work together to transform approaches to patient care.