100+ QC Executive Interview Questions and Answers

Yes, I have experience in operating and calibrating HPLC machines.

• I have operated HPLC machines to analyze samples and determine their chemical composition.

• I have calibrated HPLC machines to ensure accurate and precise results.

• I am familiar with troubleshooting common issues that may arise during HPLC operation.

• I have experience with various types of HPLC columns and detectors.

• I am knowledgeable about HPLC software and data analysis.

• I have followed standard operating procedur...read more

Karl Fischer reaction is a method for determining the water content in a sample. The instrument used for this reaction is calibrated using standard solutions.

• Karl Fischer reaction is a chemical reaction that involves the titration of water with iodine.

• It is commonly used in analytical chemistry to measure the moisture content in various substances.

• The reaction is based on the principle that iodine reacts with water to form iodide ions.

• The instrument used for Karl Fischer titr...read more

FMEA ratings are given based on severity, occurrence, and detection. Maximum rating is 10.

• FMEA ratings are given based on the severity of the failure mode, occurrence of the failure mode, and detection ability of the control measures

• Each rating is given a score from 1 to 10, with 10 being the highest

• The severity rating considers the impact of the failure mode on the customer or end user

• The occurrence rating considers the likelihood of the failure mode occurring

• The detection r...read more

21 CFR is a set of regulations by the US FDA for pharmaceutical and medical device industries. ALCOA is a data integrity acronym.

• 21 CFR stands for Code of Federal Regulations Title 21 and covers regulations for pharmaceutical and medical device industries in the US.

• ALCOA is an acronym for Attributable, Legible, Contemporaneous, Original, and Accurate, which are the principles of data integrity in the pharmaceutical industry.

• ALCOA+ is an extension of ALCOA and includes Complet...read more

Common acids and bases in labs include hydrochloric acid, sodium hydroxide, sulfuric acid, acetic acid, and ammonia.

• Hydrochloric Acid (HCl): A strong acid used for pH adjustment and cleaning.

• Sodium Hydroxide (NaOH): A strong base used in titrations and as a cleaning agent.

• Sulfuric Acid (H2SO4): A strong acid used in battery production and as a dehydrating agent.

• Acetic Acid (CH3COOH): A weak acid used in buffer solutions and food preservation.

• Ammonia (NH3): A weak base used in...read more

A soft drink is a type of beverage that typically contains carbonated water, sweeteners, and flavorings.

• Soft drinks are carbonated beverages, while beverages can include a wider range of options such as water, juice, tea, and coffee.

• Soft drinks often contain added sugars or artificial sweeteners, while beverages can be natural or flavored with various ingredients.

• Examples of soft drinks include cola, lemon-lime soda, and ginger ale, while beverages can also include sports dri...read more

Both systems and people have their strengths and weaknesses, but a balance of both is ideal.

• System-driven approaches can be more efficient and consistent, but may lack flexibility and adaptability.

• Person-driven approaches can bring creativity and problem-solving skills, but may be prone to errors and inconsistencies.

• A balance of both can lead to a strong quality control system that is both efficient and effective.

• For example, using automated testing systems to catch common er...read more

The interviewee is asked about Newtonian and non-Newtonian fluids, Reynolds number, Bernoulli's principle, and airplane working principle.

• Newtonian fluids have a constant viscosity, while non-Newtonian fluids have a variable viscosity.

• Reynolds number is a dimensionless quantity used to predict fluid flow patterns.

• Bernoulli's principle states that as the speed of a fluid increases, its pressure decreases.

• Airplanes work by generating lift through the shape of their wings and th...read more

The main components of HPLC are the mobile phase, stationary phase, pump, injector, column, detector, and data acquisition system.

• Mobile phase: The solvent or mixture of solvents that carries the sample through the system.

• Stationary phase: The solid or liquid phase that retains the analytes based on their interactions.

• Pump: Responsible for delivering the mobile phase at a constant flow rate.

• Injector: Introduces the sample into the mobile phase stream.

• Column: Contains the stat...read more

Verify instrument calibration report by checking the date, accuracy, and traceability.

• Check the date of calibration and ensure it is within the acceptable range.

• Verify the accuracy of the instrument by comparing it to a known standard.

• Ensure the calibration report includes traceability to a national or international standard.

• Check for any deviations or adjustments made during calibration.

• Verify that the calibration was performed by a qualified technician.

• Ensure that the calib...read more

Molarity, molality, and normality are all concentration units used in chemistry.

• Molarity is the number of moles of solute per liter of solution.

• Molality is the number of moles of solute per kilogram of solvent.

• Normality is the number of equivalents of solute per liter of solution.

• Molarity is temperature dependent, while molality is temperature independent.

• Normality is used in acid-base reactions to measure the concentration of acid or base in a solution.

Drones can be used for quality control inspections in various industries such as construction, agriculture, and manufacturing.

• Drones can be used to inspect hard-to-reach or dangerous areas in construction sites.

• In agriculture, drones can be used to monitor crop health and irrigation systems.

• In manufacturing, drones can help with inventory management and quality control inspections.

• Drones can also be used for surveying and mapping purposes in various industries.

Blood collection vials are specialized containers used to collect, store, and transport blood samples for laboratory testing.

• Used for various blood tests, including CBC, blood chemistry, and serology.

• Different colors indicate specific additives, e.g., red for serum, blue for coagulation tests.

• Vacutainer system allows for easy blood collection with minimal contamination.

• Some vials are designed for specific tests, like EDTA vials for hematology.

A drone is an unmanned aerial vehicle (UAV) that can be remotely controlled or fly autonomously.

• Drones are commonly used for aerial photography and videography.

• They are also used for surveillance, search and rescue missions, and delivery services.

• Some drones are equipped with sensors for various applications such as agriculture, mapping, and environmental monitoring.

Empower3 software uses various integration methods and tools for data analysis.

• Empower3 software offers integration methods such as peak detection, peak integration, and peak area calculation.

• Tools like Empower 3 Chromatography Data Software are commonly used for integration in chromatography analysis.

• Integration methods in Empower3 software help in accurately quantifying compounds in samples.

• Empower3 software allows for customization of integration parameters to suit specifi...read more

Chromatography is a technique used to separate and analyze mixtures of substances based on their different properties.

• Chromatography involves a stationary phase and a mobile phase.

• The stationary phase is a solid or liquid material that retains the components of the mixture to be separated.

• The mobile phase is a liquid or gas that carries the mixture through the stationary phase.

• Different components of the mixture interact differently with the stationary phase, leading to separ...read more

The length of HPLC column varies depending on the application and type of column used.

• The length of HPLC column can range from 30 mm to 300 mm.

• Shorter columns are used for faster separations while longer columns are used for higher resolution.

• The length of the column can also affect the retention time of the analyte.

• For example, a C18 column with a length of 150 mm is commonly used for routine analysis of pharmaceuticals.

Meta data is data that describes other data. ALCOA is a set of guidelines for data integrity in pharmaceutical industry.

• Meta data provides information about a particular data set, such as its format, author, creation date, etc.

• ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate, and is a set of guidelines for ensuring data integrity in the pharmaceutical industry.

• ALCOA+ adds two additional principles, Complete and Consistent, to the original ALCOA ...read more

Nitration reaction is a chemical reaction in which a nitro group (-NO2) is introduced into a molecule.

• Nitration is a type of electrophilic aromatic substitution reaction.

• It involves the substitution of a hydrogen atom on an aromatic ring with a nitro group.

• The reaction is typically carried out using a mixture of nitric acid and sulfuric acid as the nitrating agent.

• Nitration reactions are commonly used in the synthesis of explosives, dyes, pharmaceuticals, and other organic co...read more

Sulphated Ash and Residue on Ignition are two different methods to determine the amount of inorganic material in a sample.

• Sulphated Ash involves heating the sample with sulphuric acid to remove organic material and then heating the remaining inorganic material to constant weight.

• Residue on Ignition involves heating the sample to high temperature to burn off organic material and then heating the remaining inorganic material to constant weight.

• Both methods are used to determine...read more

I am currently earning X and my expectation is Y.

• My current CTC is X and I am expecting Y as per industry standards.

• I am open to negotiation based on the job responsibilities and growth prospects.

• I am more interested in the job profile and opportunities for learning and growth than just the salary.

• I have researched the market and have a realistic expectation based on my experience and skills.

GMP area classification categorizes environments based on cleanliness and contamination control in pharmaceutical manufacturing.

• Classified into different grades (e.g., A, B, C, D) based on the level of cleanliness required.

• Grade A areas are sterile, used for aseptic processing (e.g., filling vials).

• Grade B areas support Grade A, with controlled environments for critical operations.

• Grade C and D areas have less stringent requirements, used for less critical processes.

• Classific...read more

ELISA is a laboratory technique used to detect and quantify proteins, antibodies, and hormones in a sample.

• Types of ELISA include: Direct ELISA, Indirect ELISA, Sandwich ELISA, and Competitive ELISA.

• Direct ELISA: Detects antigens directly using enzyme-linked antibodies.

• Indirect ELISA: Involves a two-step process to detect antibodies against an antigen.

• Sandwich ELISA: Uses two antibodies to capture and detect the target antigen.

• Competitive ELISA: Measures the concentration of ...read more

Buffers in ELISA maintain pH and ionic strength for optimal antigen-antibody interactions.

• Coating buffer: Typically a carbonate-bicarbonate buffer (pH 9.6) for antigen attachment.

• Blocking buffer: Commonly BSA (Bovine Serum Albumin) or non-fat dry milk in PBS to prevent non-specific binding.

• Washing buffer: PBS or TBS with Tween-20 to remove unbound components while maintaining stability.

• Dilution buffer: Often PBS or specific assay buffers for diluting samples and reagents.

OOS investigation procedure involves identifying, documenting, and resolving deviations in quality control processes.

• Initiate investigation promptly upon observing an OOS result

• Document all relevant information including sample details, testing procedures, and environmental conditions

• Conduct root cause analysis to determine the reason for the OOS result

• Implement corrective and preventive actions to address the root cause

• Review and approve investigation report before closing t...read more

Calibration parameters for HPLC include wavelength accuracy, linearity, resolution, and peak symmetry.

• Wavelength accuracy: Ensuring the detector is accurately measuring the wavelength of the sample.

• Linearity: Verifying that the detector response is linear over a range of concentrations.

• Resolution: Assessing the ability of the HPLC system to separate peaks of interest.

• Peak symmetry: Checking the symmetry of peaks to ensure accurate quantification.

Deviation in quality control refers to a departure from standard procedures or specifications. There are two main types of deviations - major and minor.

• Deviation is a departure from standard procedures or specifications

• Major deviations are significant and can impact product quality or safety

• Minor deviations are less significant and may not impact product quality or safety

• Examples of deviations include equipment malfunction, human error, or environmental factors

The process flow in QC Executive involves several steps to ensure quality control.

• Receive and review product specifications

• Prepare and execute quality control tests

• Analyze test results and compare with standards

• Identify and report any deviations or non-conformities

• Implement corrective actions to address issues

• Document and maintain records of quality control activities

Fruits and vegetables quality standards for onion, potato, and tomato.

• Quality standards for onions include firmness, size, color, and absence of sprouting or decay.

• Potato quality is determined by factors like size, shape, skin texture, absence of blemishes or green spots.

• Tomato quality standards include firmness, color, absence of cracks or bruises, and uniform shape and size.

Normality and molarity are concentration units used in chemistry. Preparation and standardization of solutions involve precise measurements and calculations. Documentation is essential for recording procedures and results.

• Normality is a concentration unit that measures the number of equivalents of a substance in a liter of solution.

• Molarity is a concentration unit that measures the number of moles of a substance in a liter of solution.

• To prepare a solution, accurately measure...read more

I am currently working as a QC Analyst in a pharmaceutical company with 3 years of experience.

• Performed routine quality control tests on raw materials, intermediates, and finished products

• Conducted investigations into out-of-specification results and implemented corrective actions

• Maintained documentation in compliance with regulatory requirements such as cGMP

• Collaborated with production and R&D teams to ensure product quality and process improvements

pH is a measure of the acidity or alkalinity of a solution.

• pH stands for 'potential of hydrogen'.

• It is a logarithmic scale ranging from 0 to 14.

• A pH of 7 is considered neutral, below 7 is acidic, and above 7 is alkaline.

• Each unit change in pH represents a tenfold change in acidity or alkalinity.

• pH is commonly used in various fields such as chemistry, biology, and environmental science.

Coffee is called the queen of beverage due to its popularity and versatility.

• Coffee is one of the most consumed beverages in the world.

• It can be enjoyed hot or cold, with or without milk, and in various flavors.

• Coffee is a staple in many cultures and is often associated with social gatherings or relaxation.

• It is also used in various recipes and as an ingredient in desserts and cocktails.

A beverage is a liquid intended for human consumption.

• A beverage can be hot or cold

• It can be alcoholic or non-alcoholic

• Examples include water, coffee, tea, soda, beer, and wine

The quality of a product refers to its ability to meet the desired specifications and standards set by the company.

• Quality of a product is determined by its performance, durability, reliability, and consistency.

• It is important to ensure that the product meets customer expectations and complies with regulatory requirements.

• Quality control measures such as inspections, testing, and audits are implemented to maintain product quality.

• Examples of quality indicators include defect ...read more

Paint is a liquid or paste that is applied to a surface to add color, protect it, or provide texture.

• Paint is made up of pigments, binders, solvents, and additives.

• It can be applied using brushes, rollers, or sprayers.

• Paint can be used on various surfaces such as walls, furniture, and vehicles.

• Different types of paint include oil-based, water-based, and enamel.

• Paint can also be used for artistic purposes such as painting on canvas or paper.

Normality refers to the state of being normal or conforming to a standard or norm.

• Normality is a concept used in various fields to define what is considered typical or expected.

• It is often used to describe the behavior, characteristics, or values that are within the range of what is considered normal.

• Normality can vary depending on the context and can be subjective or objective.

• In statistics, normality refers to the distribution of data points following a normal distribution ...read more

HPLC is a technique used to separate, identify, and quantify components in a mixture.

• Sample preparation

• Injection of sample into the column

• Separation of components based on their interaction with the stationary phase

• Detection and quantification of separated components

• Data analysis and interpretation

Proteins are complex molecules made up of amino acids. Enzymes are proteins that catalyze chemical reactions. Bioprocess refers to the use of living organisms or their products to produce useful substances.

• Proteins are essential for the structure, function, and regulation of the body's tissues and organs.

• Enzymes are highly specific catalysts that speed up chemical reactions in the body.

• Bioprocess involves the use of microorganisms, such as bacteria or yeast, to produce useful...read more

Stability study is a process of testing the shelf life of a product under various conditions to ensure its quality and safety.

• Stability study determines the shelf life of a product

• It helps in identifying the optimal storage conditions for a product

• It ensures the quality and safety of a product over time

• Stability studies are conducted on pharmaceuticals, cosmetics, and food products

• Examples of stability testing include accelerated stability testing and real-time stability test...read more

To prepare a 1.0 N NaOH solution, dissolve 40.0 g of NaOH in enough water to make 1 liter of solution.

• To prepare a 1.0 N NaOH solution, you need to know the molar mass of NaOH (40.0 g/mol).

• Calculate the number of moles of NaOH required using the formula: moles = N x volume (in liters).

• For a 1.0 N solution, the number of moles of NaOH is equal to the desired concentration (1.0 mol/L).

• Weigh 40.0 g of NaOH using a balance.

• Dissolve the weighed NaOH in a small amount of water to m...read more

Assay by HPLC is a technique used to separate, identify, and quantify components in a sample.

• HPLC stands for High-Performance Liquid Chromatography.

• It is commonly used in pharmaceutical and chemical industries for quality control purposes.

• Assay by HPLC involves injecting a sample into a high-pressure liquid chromatography system, where the components are separated based on their interactions with the stationary phase.

• The separated components are then detected and quantified u...read more

The molecular weight of acetic acid is 60.052 g/mol.

• The molecular weight of a compound is the sum of the atomic weights of all the atoms in its chemical formula.

• The chemical formula of acetic acid is CH3COOH.

• The atomic weights of carbon (C), hydrogen (H), and oxygen (O) are 12.01 g/mol, 1.008 g/mol, and 16.00 g/mol respectively.

• Calculating the molecular weight of acetic acid: (12.01 * 2) + (1.008 * 4) + 16.00 + 1.008 = 60.052 g/mol.

The molecular weight of HNO3 is 63.01 g/mol.

• The molecular weight of a compound is the sum of the atomic weights of all the atoms in its chemical formula.

• For HNO3, the atomic weight of hydrogen (H) is 1.01 g/mol, nitrogen (N) is 14.01 g/mol, and oxygen (O) is 16.00 g/mol.

• Multiplying the atomic weights by the number of atoms in the formula (1 hydrogen, 1 nitrogen, and 3 oxygen) and summing them gives the molecular weight of HNO3 as 63.01 g/mol.

Reverse phase chromatography is a type of chromatographic technique where the stationary phase is non-polar and the mobile phase is polar.

• Stationary phase is non-polar while mobile phase is polar

• Analytes are separated based on their hydrophobicity

• Commonly used in HPLC for separating non-polar compounds

HPLC and UV are analytical techniques used in quality control. HPLC separates and quantifies components in a mixture, while UV measures the absorption of light by a sample.

• HPLC uses a stationary phase and a mobile phase to separate and quantify components in a mixture.

• Calibration of HPLC involves preparing standard solutions of known concentrations and plotting a calibration curve.

• UV measures the absorption of light by a sample at a specific wavelength.

• Calibration of UV invol...read more