Senior Pharmaceutical Analyst (Sample Management)

LIKELY QUESTIONS

- Describe your experience managing pharmaceutical samples from receipt through storage, testing coordination, retention and disposal.
- How have you applied WHO Good Practices for Pharmaceutical Quality Control Laboratories and ISO 17025 requirements in your previous roles?
- Walk us through how you would receive and assess a consignment of pharmaceutical samples before accepting it into the laboratory.
- What controls would you put in place to maintain sample identity, integrity, security and chain of custody?
- Describe your experience using a Laboratory Information System (LIS/LIMS) for sample registration, tracking, reporting and audit trails.
- How would you handle a sample received with incomplete documentation, damaged packaging, incorrect labelling or questionable storage conditions?
- How do you verify that methods of analysis, request forms, quotations and invoices align with the laboratory work performed?
- What approach would you use to establish and maintain repositories for client records, manufacturers' methods, validation data, certificates and sample inventories?

BEHAVIOURAL QUESTIONS

- Tell us about a time you identified a documentation discrepancy that could have affected laboratory traceability or result validity.
Model approach: Situation: A sample or batch record contained conflicting details, such as product name, batch number, quantity, storage condition or client request. Task: Protect traceability and prevent incorrect testing or reporting. Action: Quarantined or placed the item on hold, reviewed source documents, checked the LIMS record, contacted the client or relevant internal team, documented the discrepancy and correction, and ensured approval before release. Result: The discrepancy was resolved before testing, the audit trail remained complete, and a recurrence-prevention measure was introduced.

- Describe a time you had to manage competing priorities in a busy laboratory environment.
Model approach: Situation: Several urgent samples, routine consignments and administrative deadlines arrived at the same time. Task: Maintain turnaround times without compromising compliance or sample integrity. Action: Assessed sample risk and priority, confirmed storage requirements, allocated work based on capacity, updated the LIMS and stakeholders, and monitored progress through daily review. Result: High-priority samples were handled within required timelines, no samples were misplaced or compromised, and records remained complete.

- Give an example of when you improved a sample management process.
Model approach: Situation: The laboratory experienced delays, repeated data-entry corrections, inventory gaps or difficulty locating retained samples. Task: Improve efficiency while maintaining ISO 17025 and WHO quality requirements. Action: Mapped the existing process, identified root causes, introduced a clearer checklist, barcode or logbook control, defined responsibilities, trained users and monitored corrective actions. Result: Reduced errors or retrieval time, improved inventory accuracy, and created evidence for management review or internal audit.

- Tell us about a time you had to enforce a safety, biosafety or disposal procedure that others found inconvenient.
Model approach: Situation: A colleague, client or team faced pressure to bypass segregation, labelling, PPE, waste handling or approved disposal requirements. Task: Ensure compliance without disrupting operations unnecessarily. Action: Explained the risk and applicable procedure, stopped or redirected the unsafe activity, arranged the compliant alternative, documented the event if required and escalated appropriately. Result: Materials were handled safely, disposal remained compliant, and the team understood the importance of following the procedure.

SMART QUESTIONS TO ASK

- How is the sample management function structured, and how does this role interact with analysts, quality assurance, procurement, finance and client-facing teams?
- Which LIMS is currently used, and what are the main opportunities or challenges in sample tracking, inventory control and reporting?
- What are the most common sample-receipt nonconformities, and what authority would this role have to quarantine, reject or escalate samples?
- How does the laboratory demonstrate ongoing compliance with WHO Good Practices and ISO 17025, particularly for sample traceability, retention and disposal?
- What would success look like for the person in this role during the first six months and by the end of the two-year contract?

RED FLAGS TO WATCH FOR

- Unclear ownership of sample decisions, such as no defined authority for quarantine, rejection, deviation handling or escalation of compromised samples.
- Heavy reliance on manual records, inconsistent LIMS use or weak audit trails for sample location, chain of custody, storage conditions and disposal.
- Vague answers about staffing, workload, storage capacity, safety controls, quality oversight or resources needed to meet WHO Good Practices and ISO 17025 requirements.