Education and Training in Pharma
Home » Pharma Blog » What is a Quality Assurance Specialist?

What is a Quality Assurance Specialist?

  • quality assurance associate

A Quality Assurance Specialist monitors and records results from processes and procedures within manufacturing industries. Results are continually compared to predetermined expected ranges and any deviation from expected results leads to corrective measures.

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

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

What is Quality Assurance and what is a Quality Assurance Specialist?

Quality Assurance is part of the manufacturing quality system. It aims to prevent mistakes in the manufacturing process and defects in the finished product by implementing and monitoring processes and procedures.

Individuals within the Quality Assurance department monitor these processes and procedures, take measurements and compare them to a predefined standard. Any deviation from the standard results in corrective action at the process or procedure.

This provides a feedback loop mechanism which helps to avoid mistakes and defects.

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 assemblies, inspection of processes and implementation of production measures.

The ultimate aim of Quality Assurance is to have in place the processes that allow a repeatable result within the manufacturing process – a satisfactory finished product that meets all industry standards.

Some Companies Might Call This Role…

  • QA Associate
  • Quality Assurance (QA) Technician
  • QA Specialist

What Does a Quality Assurance Specialist Do?

Quality Assurance Specialists (sometimes referred to as Quality Assurance Associates) are the individuals tasked with the “on the floor” implementation of the Quality Assurance protocols. The individual tasks will vary depending on the type of product being manufactured but can include:

  • Monitoring and providing guidance to production personnel as required
  • Auditing the plant processes to ensure both internal and external regulations and standards are being adhered to
  • Provide insight to improve processes and practices to ensure manufacturing quality is maintained while efficiency is optimized
  • Review of cGMP documents to ensure company processes comply
  • Production staff training on quality procedures, protocols, and documentation
  • Maintenance of Quality Assurance documentation
  • Development of the standard measurements for processes to be compared against
  • Inspection and testing of processes and procedures – taking measurements and comparing to predefined standard
  • Investigation when measurements are found to deviate from standards
  • Writing Standard Operating Procedures (SOPs) for the manufacturing process
  • Ensuring auditing and manufacturing documentation is kept up to date.

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 (NCABR). It gives a great outline of a ‘day in the life’ of a Quality Assurance Specialist.

Becoming a Quality Assurance Specialist

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 training to candidates showing the right traits and skills.

High school or secondary school level education along with industry knowledge and experience can be sufficient for candidates possessing the key attributes outlined below. A science/engineering BSc degree without industry experience can be an alternative route.

If you want to know more about making a mid-career change into this area, the first step is our 30-week conversion certificate course eBioPharmaChem.

What Skills Do I Need?

The ideal skill set for someone moving into quality assurance includes:

  • 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

Quality Assurance Specialist 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.

Quality Assurance Specialist 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, the UK, and Philadelphia, USA.

Post Your Comments Below

Close