Labcorp QA Auditor Job Opening For BSc & MSc Life Sciences, Apply Online
Labcorp QA Auditor Job Opening For BSc & MSc Life Sciences, Apply Online. MSc, BSc Life Sciences QA Auditor III ( Method Validation, Dose Analysis and GLP regulation understanding) job at Labcorp. Interested and eligible applicants can check out all of the details on the same below
A few Interview Questions and Answers for QA Auditor-III role at Labcorp are posted below
QA Auditor III ( Method Validation, Dose Analysis and GLP regulation understanding)
Category: Regulatory/Compliance
Location: Bangalore, India
Job Id: 2341522
Job Type: Full-Time
Job requirements:
- Conduct work as identified on the audit activity table (listing on table is not all inclusive but a representative sample) and review audit responses for completeness
- Support ‘business partner’ /liaison meetings representing QA function with operations (local)
- Report on relevant quality metrics (for single topics/departments) and highlight trends
- Adhere to required timeline on assigned activities
- Peer Review QA SOP’s
- Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed
- Other duties as assigned by management.
Experience:
Minimum Required:
- 3 years in regulatory environment (experience in GXP roles)
- Knowledge of and ability to interpret and apply (applicable) regulations in order to monitor compliance
- Ability to interpret data and identify quality critical problems
- Able to convey regulatory expectations
- Adaptability to an ever changing work environment
- Ability to ‘challenge’ processes – not just accept status quo and make suggestions to improve
Education:
Recommended:
- A minimum of Master’s a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)
- Experience may be substituted for education.
Here are a few Interview Questions and Answers for QA Auditor-III role at Labcorp:
- Can you provide an example of an audit activity you would perform as a QA Auditor III in Labcorp? Example Answer: As a QA Auditor III, one of the audit activities I would conduct is the verification of method validation procedures. This involves reviewing the validation protocols, data, and reports to ensure compliance with regulatory requirements and industry standards. I would assess the adequacy of validation parameters, accuracy of results, and documentation practices to guarantee the reliability of the analytical methods used in our operations.
- How would you handle a situation where you identify a non-compliance during an audit? Example Answer: If I identify a non-compliance during an audit, I would first document the findings and gather all relevant evidence to support my observations. I would then communicate the non-compliance to the appropriate stakeholders, including the individuals responsible for the process or area in question. I would work collaboratively with them to understand the root cause of the non-compliance and develop a corrective action plan to address it. Regular follow-up and monitoring would be conducted to ensure the non-compliance is effectively resolved.
- Can you share an experience where you had to convey regulatory expectations to a team or department? Example Answer: In a previous role, I had to convey regulatory expectations to a department responsible for handling controlled substances. I organized a meeting with the team and presented a detailed overview of the relevant regulations, emphasizing the importance of compliance and the potential consequences of non-compliance. I provided clear guidance on record-keeping, security measures, and reporting requirements. Throughout the process, I encouraged open dialogue, answered questions, and ensured that the team had a clear understanding of their responsibilities in meeting regulatory expectations.
- How do you stay updated on the latest regulatory requirements and changes? Example Answer: To stay updated on the latest regulatory requirements and changes, I actively engage in continuous learning and professional development. I regularly review regulatory publications, attend seminars and conferences, and participate in relevant industry forums. Additionally, I am a member of professional organizations that provide updates and networking opportunities with experts in the field. I also make use of online resources, such as regulatory websites and newsletters, to ensure I am well-informed and can effectively apply the latest regulatory knowledge in my work.
- Can you describe a time when you challenged a process and suggested improvements? Example Answer: In my previous role, I noticed a recurring issue in the sample handling process that was causing delays and potential errors. I initiated a discussion with the team involved, highlighting the challenges and proposing a revised workflow that would streamline the process and mitigate the identified issues. I presented data supporting the proposed changes and collaborated with team members to implement and test the improvements. The revised process resulted in improved efficiency, reduced errors, and increased customer satisfaction.
Note: The answers provided are examples and should be customized based on personal experiences and qualifications.
ALL THE BEST!
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