What is a Quality Assurance Specialist and what do they do? | GetReskilled (2024)

By: Donagh Fitzgerald and Claire Wilson. Last Updated: April 2024

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• QA Specialist
• Quality Assurance Technician
• QA Technician
• Quality Assurance Associate
• QMS/QA Specialist
• QA Internal Auditor
• Quality Systems Coordinator

According to salary.com, the median salary for a quality assurance specialist in 2023 in the United States is $65,760.

What is the difference between Quality Assurance Specialist and Quality Assurance Analyst?

According to the BLS, the title of a Quality Assurance Analyst is used more commonly to describe the role of a software tester.

Let’s take a closer look at the details of quality assurance and the role of a Quality Assurance Specialist.

Quality Assurance is process-oriented and focuses on eliminating all process variation by creating, revising and strictly implementing a set of tightly and precisely defined processes, procedures and checklists that when exactly followed, ensure the final quality of the product.

Quality Assurance is preventative by nature and is not concerned with the measurement or inspection of that finished product – that is the role of Quality Control.

Quality Assurance vs Quality Control – Checklists vs Testing

Quality Control is product-oriented and focuses on testing a sample of a manufacturing process to make sure that it meets the required design specifications or quality standards.

Instead, Quality Assurance focuses on areas such as monitoring and inspection of the methods (not the product) used in production processes, documenting procedures, conducting audits, and creating and implementing, process checklists, process standards and standard operating procedures (SOPs).

Quality Assurance is typically reflected on the factory floor through the use of aQuality Management System(QMS). Thisis a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.

ISO 9001:2015 is the most recognised and widely implemented quality management system. But there are many others.

Note: While many of the techniques and approaches in quality assurance were developed for the manufacturing industry, they are widely applied in a variety of other sectors such as customer care, software development, aviation, oil and gas, regulatory compliance, etc.

Quality Assurance Specialists (sometimes referred to as Quality Assurance Associates) individual tasks will vary depending on the type of product being manufactured but can include:

• Auditing the manufacturing processes to ensure both internal and external regulations and standards are being adhered to
• Ensuring auditing and manufacturing documentation is kept up to date.
• Drive continuous improvement of core processes to ensure manufacturing quality is maintained while efficiency is optimized
• Train and provide assistance to less experienced members of the QA team on quality procedures, protocols, and documentation
• Train production staff on quality procedures, protocols, and documentation
• Maintain Quality Assurance documentation
• Develop the standard measurements for processes to be compared against
• Inspect and test processes and procedures – take measurements and compare to a predefined standard
• Investigate measurements that are found to deviate from standards
• Write Standard Operating Procedures (SOPs) for the manufacturing process
• Coordinate investigation of quality issues with customers and suppliers
• Review, approve and communicate root cause and corrective action to stakeholders
• In the pharma and med device industry, review of cGMP and other GxP documents to ensure company processes comply

Have a look at this short video from the About Bioscience website, produced by the North Carolina Association for Biomedical Research. It gives a great outline of a ‘day in the life of a Quality Assurance Specialist.

The paths into the role of a Quality Assurance Specialist are wide and varied and depend on the particular sector you are working such as manufacturing, the service sector, pharmaceutical or medical device manufacturing, software development, aviation, oil and gas, regulatory compliance, etc.

But either way, to become a quality assurance associate, you typically need:

• a high level and deep understanding of the systems, processes and procedures to perform the role of quality assurance on. Depending on the sector, you may need a technical qualification to prove this
• training in the relevant Quality Management System(QMS) such as ISO 9001:2015 and/or training in process improvement techniques such as Six Sigma or Lean Six Sigma
• training in Quality Risk Management (QRM) tools such as Fault Tree Analysis, Failure Mode Effect Analysis, Cause and Effect Diagrams, etc

In the manufacturing sector, a Bachelor’s Degree in a lab/science or an engineering discipline such as mechanical, industrial, production, or manufacturing engineering is the typical requirement for quality assurance roles. The techniques used in quality assurance are usually added on to a lab/science or engineering qualification or learned on the job.

High school or secondary school level education along with industry knowledge and experience can be sufficient for candidates possessing the key attributes are often sufficient as well. The right basic skill set and personal qualities are more important than a certain level of education in Quality Assurance Specialists. Many companies will provide on-the-job training in quality management systems to candidates showing the right traits and skills.

Certifications can also help your career prospects in certain countries (Do note that recognition of qualifications varies from industry to industry). For example, The American Society for Quality offers a Quality Technician Certification along with other industry certifications that deal with various aspects of quality practices.

In addition to the requirements outlined above, you will also need to be well versed in Good Manufacturing Practices (GMPs), have a deeper understanding of Quality Risk Management and be familiar with Validation and Equipment Validation Protocols.

If you already work as a quality assurance technician and would like to retrain to perform the same or similar role within the pharmaceutical or medical device industry, check out our Conversion Course into Quality Roles in Pharma.

This program is the quickest way to learn all you need to, to successfully move into Quality Assurance or Quality Control roles in Pharmaceutical manufacturing from a different industry.

Depending on your previous experience, here are some of the most common job titles we see advertised;

• Quality Assurance
• Quality Assurance Specialist
• Quality Assurance Associate
• Associate Manager
• Quality Assurance
• Plant Quality Assurance Senior Associate
• QA Specialist – Raw Materials
• QA Compliance Specialist
• QMS/QA Specialist
• QA Internal Auditor
• QA Compliance Manager
• Quality Systems Coordinator

The top skills for someone moving into quality assurance include:

• Analytical skills – will gather and interpret data, have to be able to spot trends and notice outliers
• Organisational skills – needed to keep track of testing, results, documentation, and recommendations
• Excellent written communication – concise and accurate written documentation is essential. Also required to review internal and external guidance, and potentially write company SOPs
• Interpersonal skills – involved in training production staff on quality systems, also working closely with production staff to find and adjust errors in the processes
• Keen attention to detail – must be able to spot when processes don’t comply with guidance and provide alternative suggestions. Have to be able to read and interpret the details of external guidance and industry regulations
• Critical/logical thinking – have to identify problems but also be able to help provide novel solutions to ensure efficiency and quality of the manufacturing process

Check out oursalary guideforQuality Assurance Specialist salary information local to you.

As with all resumes, it’s extremely important that you tailor your Quality Assurance Specialist resume to reflect the language used within the job advert. Where you have relevant experience or skills, use the words and phrases that the employer has used to describe them. Do not assume that someone will read similar wording and know what you mean.

Quality Assurance Specialist roles will typically be looking for the skills previously outlined:

• Analytical skills
• Organisational skills
• Excellent written communication
• Interpersonal skills
• Keen attention to detail
• Critical/logical thinking

For more help with your resume, check out these templates and this list of30 tips to improve your resume.

Manufacturing/Production

• Process Technician
• Process Operator
• Manufacturing Technician
• Production Operator
• Packaging Operator
• Production Supervisor

Engineering

• Process Engineer
• Manufacturing Engineer
• Instrumentation Engineer
• Project Engineer
• Automation Engineer

Maintenance

• Facilities Engineer
• Calibration Technician
• Maintenance Technician

Quality

• Quality Engineer
• Documentation Specialist
• Quality Control Analyst

Science/Laboratory

• Biochemist
• Laboratory Technician
• Microbiologist

Validation

• Validation Engineer
• CQV Engineer
• Validation Technician
• CSV Engineer

• Pharmaceutical Validation Training Course – for More Senior Validation roles
• Computer System Validation (CSV) Course
• GMP Training for the Pharmaceutical Industry
• View All 13 Pharmaceutical Courses

Donagh looks after the marketing and product development including the training and pedagogical elements of our programs and makes sure that all GetReskilled’s users can have a great online learning experience. Donagh has lived and worked in many countries including Ireland, America, the UK, Singapore, Hong Kong and Japan. Donagh has also served as the Program Manager for the Farmleigh Fellowship based out of Singapore.

Donagh holds Degrees in Production Engineering and Mechanical Engineering from South East Technological University, Ireland.

Claire runs GetReskilled’s Advanced Career Coaching Programme – our specially devised job hunting course that helps our trainees take that final step into employment by leading them through the job hunting process. She is extremely enthusiastic about helping people reach their final goal of employment in their new career path.

Claire has a BSc (Hons) in Medical Biology from Edinburgh University and spent 7 years working in the pharmaceutical and medical device industries.