Nova IVF Fertility QA Chemist Interview: Rounds, Questions and Preparation

What the job involves

A QA Chemist in the healthcare and pharma sector, including fertility clinics, ensures that raw materials, in-process samples, and finished products meet quality specifications. Day to day, they perform analytical tests, document results, investigate deviations, and support regulatory compliance. In a fertility clinic setting, they may also test culture media, reagents, and water quality to ensure patient safety.

Role and Technical Knowledge

1. 1

   What is the difference between quality control and quality assurance in a pharma or fertility clinic setting?

   Explain that QC focuses on testing and detecting defects in products, while QA focuses on preventing defects through systems and processes. Give an example like QC testing raw materials versus QA auditing documentation.

2. 2

   Which analytical techniques are you familiar with, and how would you use one to test a hormone injection?

   Mention techniques like HPLC, UV-Vis, or ELISA. For a hormone injection, HPLC is common for assay and purity. Describe steps: sample preparation, standard preparation, system suitability, and result calculation.

3. 3

   What is ALCOA+ and why is it important in a regulated lab?

   ALCOA+ stands for Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available. It ensures data integrity for regulatory audits and patient safety.

4. 4

   How do you handle an out-of-specification (OOS) result?

   Outline the OOS investigation process: immediate retest, phase I lab investigation, phase II manufacturing investigation, root cause analysis, and corrective actions. Emphasize documentation and not discarding original data.

Practical Scenarios

1. 5

   You are testing culture media for a fertility clinic and find the pH is slightly outside the acceptable range. What do you do?

   Describe checking calibration of the pH meter, preparing a fresh sample, retesting, and if confirmed, quarantining the batch and initiating a deviation report. Mention notifying the supervisor and documenting everything.

2. 6

   During an HPLC run, the baseline is noisy and retention times are shifting. How do you troubleshoot?

   List steps: check mobile phase preparation and degassing, inspect column and lamp, verify detector settings, and run a system suitability test. If unresolved, escalate to senior analyst and document the issue.

3. 7

   You need to prepare a 0.1 M sodium hydroxide solution for a titration. How would you do it?

   Calculate required mass (4 g for 1 L), weigh accurately, dissolve in distilled water, transfer to volumetric flask, make up to volume, and standardize if needed. Mention using calibrated balance and recording all steps.

4. 8

   A colleague asks you to sign off on a test result you did not perform. What do you do?

   Refuse politely, explain that only the analyst who performed the test can sign, and suggest they complete the documentation themselves. Highlight integrity and regulatory compliance.

Behavioural and HR

1. 9

   Tell me about a time you made a mistake in a lab practical or project. How did you handle it?

   Use STAR method: describe the mistake, how you immediately reported it, corrected it, and what you learned. Show honesty and accountability.

2. 10

   How do you prioritize tasks when you have multiple samples to test before the end of the day?

   Explain assessing urgency, stability of samples, and deadlines. Mention communicating with supervisor if timelines are tight and maintaining accurate records.

3. 11

   Why do you want to work in a fertility clinic as a QA chemist?

   Connect personal interest in healthcare and patient safety. Mention the importance of quality in sensitive procedures like IVF and how your skills can contribute.

4. 12

   Describe a situation where you had to work in a team to solve a problem.

   Give a lab or project example. Highlight your role, how you collaborated, and the positive outcome. Emphasize communication and respect for others' inputs.

Regulatory and Documentation

1. 13

   What is the difference between a deviation and an incident in a quality system?

   A deviation is a planned or unplanned departure from an approved procedure, while an incident is an unexpected event that may or may not affect product quality. Both require documentation and investigation.

2. 14

   How do you ensure data integrity when recording lab results?

   Mention using indelible ink, no overwriting, single-line strike-through with initials and date for corrections, and recording data contemporaneously. Also mention audit trails in electronic systems.

3. 15

   What are the key elements of a standard operating procedure (SOP) for a lab instrument?

   Include purpose, scope, responsibilities, procedure steps, calibration, maintenance, safety, and documentation. Emphasize that SOPs must be followed exactly and reviewed regularly.

4. 16

   Why is instrument calibration important, and how often should it be done?

   Calibration ensures accurate and reliable results. Frequency depends on instrument use, manufacturer guidelines, and regulatory requirements. Mention documenting calibration and out-of-calibration actions.