Quality Control Analyst job description
A quality control analyst tests raw materials, in-process samples and finished batches in a pharma laboratory and records the results so that only batches that meet specification are released.
Why the role exists
The role exists because a batch cannot move to packing or dispatch until the laboratory has tested it. In an Indian formulation or API unit the analyst sits in the QC laboratory, reports to the QC head or section in charge and works closely with production and quality assurance.
What the person does
- Receive samples from the warehouse and production, log them in the laboratory register and test them in the sequence set by the QC head.
- Run HPLC, GC, UV, dissolution, disintegration and similar tests as per the approved method and the current standard testing procedure.
- Record every observation in the raw data sheet or electronic system at the time of testing, never later from memory.
- Prepare and standardise reagents, volumetric solutions and reference standards, and label them with preparation and expiry details.
- Calibrate and clean instruments as per schedule and log each activity in the instrument usage logbook.
- Report any out of specification or out of trend result to the QC head straight away and do not repeat tests without approval.
- Maintain the retention sample room, working standards and chemical stock, and flag shortages before testing is held up.
- Support stability studies, method transfer and audits by pulling records and explaining how a test was done.
Skills and tools
- Hands-on use of HPLC, GC, UV spectrophotometer, dissolution tester, balances and pH meters
- Wet chemistry skills such as titration, assay and loss on drying
- Good documentation practice: contemporaneous, legible and traceable entries
- Understanding of pharmacopoeial methods and how a specification is read
- Awareness of data integrity and why audit trails and raw data matter
- Basic knowledge of laboratory safety, solvents and waste disposal
- Ability to analyse chromatograms and spot a problem with the system suitability
- Calm reporting of an unexpected result without hiding or adjusting it
Education and experience
Preferred, never a bar: equivalent experience counts.
- B.Sc or M.Sc in chemistry, analytical chemistry or a related subject preferred, or B.Pharm or M.Pharm
- Experience in a pharma QC laboratory is preferred; a fresher with strong lab practice can be trained
- Experience with an electronic chromatography data system is useful but not essential
- Any training records or certifications the employer expects should be confirmed with your own adviser
How the work is judged
- Accuracy and right-first-time quality of test results and records
- Turnaround of sample testing against the laboratory plan, without shortcuts in method
- Completeness and timeliness of documentation, with few review corrections
- Handling of out of specification and deviation events, including prompt escalation
- Instrument upkeep and calibration records kept current and audit ready
Where the role can lead
- Senior analyst or section in charge for a technique such as HPLC or microbiology
- QC executive or officer handling method transfer, stability and out of specification investigations
- Move into quality assurance or analytical method development with further experience
Interview questions to ask
Ask every candidate the same questions in the same order and score them against written anchors, so the decision rests on the work and not the impression.
- Your assay result is just outside the limit. Describe step by step what you do before and after telling your supervisor.
- How do you record a result when you realise you wrote the wrong figure in the notebook ten minutes ago?
- Which instruments have you used on your own, and what would you check first if the HPLC baseline is noisy?
- Production is waiting for your release test and the dissolution bath is under calibration. What do you do?
- How do you prepare and label a standard solution so that another analyst can trust it?
- Tell me about a time you found a mistake made by a colleague in a record. How did you raise it?
Hiring tips for this role
- Give a practical test: ask the candidate to read a short chromatogram and explain system suitability. Certificates alone do not show hands-on skill.
- Ask about data integrity in plain terms. A candidate who says results can be repeated until they pass is a risk to your inspections.
- Check that the instruments they claim to have handled match what your laboratory has, so training time is realistic.
- Do not hire only on years in a lab; a person from a large plant may have run one instrument only. Ask about the breadth of work.
Questions about hiring a quality control analyst
In many small units the titles overlap, but an analyst usually performs and records tests and reports results, while a technician assists with preparation and upkeep. Define the duties in the job description so the candidate knows which role it is.
Not always. Chemistry and pharmacy graduates are both common. Any qualification or training the employer expects for regulated work depends on the employer and the facts, so confirm it with your own adviser.
It depends on the plant. Units that test round the clock may use shifts, while smaller laboratories work general hours with occasional extended days before batch release. State this clearly in the offer.
GullyHR agrees the job description with you, finds and screens candidates for your laboratory and supports the offer. We hire for your permanent team and do not supply contract staff.
Hiring a quality control analyst?
GullyHR runs talent acquisition for permanent roles. We agree the job description with you, find and screen candidates against it, and support the offer through to joining. We recruit permanent employees. We do not supply contract or temporary staff.