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.
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 is process oriented and focuses on eliminating process variation by creating, revising and strictly implementing a set of tightly and precisely defined process/procedures/quality standards 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.
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 on-the-job 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 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 30-week Certificate in BioPharmaChem conversion program.
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
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