20+ Quality Specialist Interview Questions and Answers

Vlookup is a function in Excel used to search for a specific value in a table and return a corresponding value from another column.

• Vlookup stands for 'Vertical Lookup'

• It is used to find a specific value in a table

• It returns a corresponding value from another column

• It requires at least two arguments: the value to search for and the table to search in

• It can be used with or without an exact match

• Example: =VLOOKUP(A2, B2:C10, 2, FALSE) will search for the value in cell A2 in the ...read more

Line clearance check points ensure safety and quality in the production process.

• Verify that all equipment and materials from the previous batch have been removed.

• Ensure that the production area is clean and free from any contamination.

• Confirm that all required documents and records are in place and properly filled out.

• Check that the equipment is properly calibrated and functioning correctly.

• Inspect that the correct raw materials and components are available and properly label...read more

Quality is meeting or exceeding customer expectations through consistent and reliable products or services.

• Quality is a measure of how well a product or service meets customer needs and expectations.

• It involves consistent and reliable performance, meeting specifications and standards, and continuous improvement.

• Examples of quality include a car that runs smoothly and reliably, a restaurant that consistently serves delicious food, and a software program that is bug-free and us...read more

BUA samples are taken from the calcaneus bone using a specialized ultrasound device.

• BUA stands for Broadband Ultrasound Attenuation

• Samples are taken from the heel bone (calcaneus)

• A specialized ultrasound device is used to measure BUA

• The procedure is non-invasive and painless

An audit trail is a record of all the events that occur during a process or transaction.

• It provides a chronological sequence of events.

• It helps in identifying errors, fraud, or unauthorized access.

• It ensures accountability and transparency.

• Examples include electronic medical records, financial transactions, and software development.

• It is important for compliance with regulations and standards.

Different types of checks include visual, functional, and dimensional checks.

• Visual checks involve inspecting the product for any defects or abnormalities.

• Functional checks involve testing the product to ensure it performs its intended function.

• Dimensional checks involve measuring the product to ensure it meets the required specifications.

• Checks can be performed manually or using automated equipment.

• Examples include visual inspection of a car for scratches, functional testing...read more

The standard used for Rockwell hardness tester is ASTM E18.

• ASTM E18 is the standard used for Rockwell hardness testing

• It provides guidelines for the testing procedure and equipment calibration

• The standard ensures consistency and accuracy in hardness testing results

Challenges faced while using a compression machine

• Ensuring proper calibration of the machine

• Maintaining consistent pressure and temperature

• Preventing contamination of the sample

• Ensuring proper cleaning and maintenance of the machine

• Dealing with unexpected errors or malfunctions

Cpk is a statistical measure used to determine the capability of a process to produce products within customer specifications.

• Cpk measures the distance between the process mean and the closest specification limit.

• A Cpk value of 1 indicates that the process is capable of producing products within specifications.

• A Cpk value of less than 1 indicates that the process is not capable of producing products within specifications.

• Cpk is calculated using the formula: Cpk = min(USL - me...read more

Amazon's technical projects include Amazon Web Services (AWS), Alexa, Prime Air, and Amazon Go.

• Amazon Web Services (AWS) - cloud computing platform

• Alexa - virtual assistant AI technology

• Prime Air - drone delivery service

• Amazon Go - cashier-less convenience stores

To prepare PMS plans, follow these steps: define objectives, identify target population, select data collection methods, determine data analysis techniques, establish timelines and milestones.

• Define the objectives of the post-market surveillance (PMS) plan.

• Identify the target population or patient group that will be monitored.

• Select appropriate data collection methods, such as surveys, interviews, or data analysis of existing databases.

• Determine the data analysis techniques t...read more

ALCOA principle is a set of guidelines for data integrity in pharmaceutical manufacturing.

• ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate.

• It is used to ensure the quality and reliability of data in pharmaceutical manufacturing.

• Attributable means that all data must be linked to the person who generated it.

• Legible means that all data must be clear and easy to read.

• Contemporaneous means that data must be recorded at the time of the activity.

• Origin...read more

To tackle complex situations, break it down into smaller parts, prioritize tasks, seek input from others, and stay calm under pressure.

• Break down the complex situation into smaller, more manageable parts

• Prioritize tasks based on importance and urgency

• Seek input and advice from colleagues or experts in the field

• Stay calm and focused under pressure to make rational decisions

• Create a plan of action and adjust as needed based on new information

• Communicate effectively with team me...read more

AQL stands for Acceptable Quality Level and is a statistical sampling method used to determine the quality of a product or batch.

• AQL is used to determine the maximum number of defective items in a batch that is considered acceptable.

• It involves randomly selecting a sample of items from the batch and inspecting them for defects.

• The AQL level is determined based on the level of quality required for the product and the associated risks.

• For example, an AQL of 1.5 means that no mo...read more

As a Quality Specialist, key responsibilities include ensuring compliance with regulations, identifying and resolving quality issues, and implementing quality improvement initiatives.

• Ensuring compliance with regulations and standards

• Identifying and resolving quality issues

• Implementing quality improvement initiatives

• Conducting audits and inspections

• Developing and maintaining quality documentation

• Providing training and support to staff

• Collaborating with cross-functional teams

• Mo...read more

Validation is the process of ensuring that a product or service meets the specified requirements and standards.

• Validation is done to confirm that the product or service meets the intended use and customer needs.

• It involves testing and verifying the product or service against the requirements and specifications.

• Validation is important in industries such as pharmaceuticals, medical devices, and software development.

• Examples of validation include user acceptance testing, equipme...read more

I am currently earning a salary of $60,000 per year at my current company.

• My last drawn CTC at my current company is $60,000 per year

• I am currently earning $5,000 per month at my current job

Interface is a point where two systems, subjects, organizations, etc. meet and interact with each other.

• Interface is a boundary or point of interaction between two entities.

• It allows for communication, data transfer, or interaction between the entities.

• Examples include user interfaces on electronic devices, software interfaces, and physical interfaces like USB ports.

Amazon Principles are a set of guidelines that drive the company's culture and decision-making process.

• Customer Obsession: Always prioritize the customer and work backwards from their needs.

• Ownership: Take responsibility and act on behalf of the entire company.

• Invent and Simplify: Continuously innovate and simplify processes.

• Are Right, A Lot: Make decisions based on data and strive for high-quality results.

• Learn and Be Curious: Continuously seek to improve and learn new thing...read more

Reverse a string by iterating through each character and appending to a new string.

• Iterate through each character of the input string

• Append each character to a new string in reverse order

• Return the reversed string