quality assurance associate

What is Quality Assurance Specialist?

A Quality Assurance Specialist checks the implementation of the quality system, conducts quality assurance audits and monitors and records results from processes and procedures within manufacturing industries. They continually compared results to predetermined expected ranges and take corrective measures if any deviation is found.

These quality checks ensure the ongoing reliability of the manufacturing process.

Some Companies Might Call This Role…

  • Quality Assurance Associate
  • Quality Assurance (QA) Technician
  • QA Specialist
  • QMS/QA Specialist
  • QA Internal Auditor
  • QA Compliance Manager
  • Quality Systems Coordinator

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

What is Quality Assurance?

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

It is important to note that Quality Assurance is operating at the level of manufacturing processes and procedures. While the aim is to ultimately maintain the quality of the finished product, Quality Assurance is not concerned with measurement or inspection of that finished product – that is the role of Quality Control.

Instead, Quality Assurance focuses on areas such as inspection of raw materials, monitoring and inspection of the production processes, documenting procedures and implementation of production measures.

The ultimate aim of Quality Assurance is to implement standard processes that allow a repeatable result within the manufacturing process and produce a finished product that meets all industry standards.

Quality Assurance is typically reflected on the factory floor through the use of a Quality Management System (QMS). This is 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.

What Does a Quality Assurance Specialist Do?

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 plant 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
  • Review of cGMP documents to ensure company processes comply
  • 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

Watch this Video on a Quality Assurance Specialist’s Role

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.

Becoming 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 a mechanical, industrial, production, manufacturing engineering is the typical requirement for quality assurance roles. The techniques used in quality assurance are usually added onto 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.

Become a Quality Assurance Specialist in the Pharma or Med Device Manufacturing Industry

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

What are Top Skills for Quality Assurance Specialist?

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

Salaries & Job Growth

Check out our salary guide for Quality Assurance Specialist salary information local to you.

Quality Assurance Specialist Resume Tips

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 of 30 tips to improve your resume.

Job Vacancies

For more information on currently available Quality Assurance Specialist roles, head to our jobs boards and select Quality in the “Jobs by Category” menu. We currently have jobs boards for Ireland and the UK