The Role of a Quality Assurance Specialist: What You Need to Know

Quality assurance (QA) is a specialist role needed in all manner of industries. QA specialists are the people making sure goods and services meet expected standards of quality, safety, and reliability.

In Ireland, the pharmaceutical, MedTech, food, and manufacturing sectors are growing, and fast, with the country home to many of the top global companies. Each of these industries has a rising demand for quality assurance specialists to help maintain high standards and compliance with regulatory requirements.

QA specialists are the frontline defence in safeguarding consumer trust and protecting the reputation of businesses. In this article, we’ll demystify the QA job role and help you understand what’s expected from this exciting career.

What is Quality Assurance?

Quality assurance is the systematic process that tests products and services to see if they meet specified requirements and standards. This may involve a series of planned activities, including:

Monitoring and audition production processes
Defining and documenting quality procedures
Creating standard operating procedures (SOPs)
Developing process checklists
Inspecting goods and services
Identifying production problems

QA is a serious job role as it’s pivotal in maintaining consumer safety. Specialists find and resolve issues to make sure products are free from defects and safe for use. It’s an evolving role as new regulatory standards may be introduced. So, QA specialists will need to ensure production meets these standards to avoid legal issues and potential recalls.

Beyond consumer safety, QAs also contribute to many aspects of a business. They improve operations, test and improve systems, minimise the possibility of potential downtime, and train staff on procedures.

If you’re interested in a varied quality assurance role in the food and beverage industry, consider training in Food Science at Innopharma to learn how QA plays a role in the food you eat.

What Does a Quality Assurance Specialist Do?

A quality assurance specialist’s duties are diverse and vital to operational success. Without a proper QA team, companies risk falling short of their regulatory commitments and facing financial losses. This may come in the form of product recalls, legal penalties, or damage to the company’s reputation.

Businesses take QA very seriously, and so they expect their employees to perform several critical functions, including:

Developing and implementing quality management systems (QMS)

Creating and maintaining quality policies and procedures: This involves drafting all documentation outlining the expected quality standards and practices employees must adhere to. Policies will be regularly updated to reflect any new regulations and best practices in the industry.
Establishing Standard Operating Procedures (SOPs) for consistency and compliance: QA specialists design these SOPs to detail the exact processes and steps required for different parts of the operation.

Conducting regular audits and inspections

Performing internal audits: These audits involve systematically reviewing processes and documentation to ensure compliance with internal and external quality standards.
Inspecting production processes and final products: QA specialists may be expected to check for defects, deviations from specifications, and make sure any issues are addressed to prevent occuring again.

Identifying areas for improvement and suggesting solutions

Identifying root causes of quality problems: QA specialists use tools like Fault Tree Analysis (FTA) and Fishbone Diagrams to map out potential causes. They can then determine corrective actions to prevent future occurrences.
Coordinating with other departments to resolve quality-related issues: This collaboration ensures the production process matches quality standards and any cross-departmental issues are resolved.

Training production and operation staff on quality protocols

Educating employees about quality protocols and best practices: QAs educate employees on quality protocols and best practices to maintain expectations.
Providing ongoing training with the latest quality standards: QA specialists will host ongoing training sessions to keep all staff updated on changes to industry regulations and internal practices.

QAs ensure rigorous quality standards are met and help their organisation produce safe products for consumers, thereby protecting consumer health and business reputation.

Quality Assurance Specialist Job Description

A quality assurance specialist plays an important role for the company they work for, so hiring managers often seek technically-minded people with strong problem-solving abilities.

QA’s usually work as part of a team, reporting to a QA manager or lead. The first job role is typically that of a junior QA analyst or junior tester. At this level, you will be expected to help with test plan development and execution and compile reports on results.

Job descriptions may ask for candidates with experience and certification in methodologies like:

Six Sigma: Aim to minimise variations in the end product. Six Sigma focuses on using statistical data to identify and remove defects.
Total Quality Management (TQM): TQM relies heavily on data-driven decisions and performance metrics. The entire team helps to optimise processes and improve overall customer satisfaction.
Kaizen: Kaizen focuses on making small, incremental changes over time to optimise processes and eliminate waste. It warrants a collective effort of all employees to identify and implement improvements.
Plan Do Check Act (PDCA): Also known as the Deming cycle, this iterative process involves four steps: planning the change, implementing the change (do), checking the results, and acting on what is learned to refine the process.
Lean Manufacturing: Focuses on reducing waste within manufacturing systems while simultaneously increasing productivity. Lean principles include identifying value, mapping the value stream, creating flow, establishing pull, and pursuing perfection through continuous improvement.

Skills & Qualifications

To stand out as a QA specialist, one must have strong attention to detail, problem-solving abilities, and analytical skills. A QA must also be able to interpret complex regulations and apply them to manufacturing processes.

Educational requirements will usually include a degree in science, engineering, or a related field. It may also be necessary to seek certain certifications such as Six Sigma or ISO standards. These certifications are highly valued as they demonstrate a specialist’s commitment to quality and process improvement.

Salaries

In Ireland, the salary of a QA specialist can vary depending on experience, education, and industry. The average salary is around €50,000 annually, and the most experienced specialist draws a salary closer to €80,000.

How to Become a Quality Insurance Specialist

As quality assurance is a specialist role, prospective employees will typically need some form of formal training. This may be achieved through education, hands-on work experience, or a combination of the two.

Educational Pathways

Most quality assurance (specialists start with a degree in science, engineering, or a related field. Degrees in chemistry, biology, or industrial engineering are particularly relevant.

Obtaining certifications such as Six Sigma, ISO 9001, or Lean Manufacturing are a great way of making yourself stand out and boosting your hireability. Certifications of this kind show you’ve acquired relevant knowledge of quality management systems and process improvement techniques.

Gaining Relevant Experience

Prospective QAs can gain practical experience through internships in pharmaceutical, manufacturing, or tech industries. Internships provide essential hands-on experience and an understanding of industry standards and practices.

Entry-level roles such as Quality Control Technician or Production Assistant help build foundational skills and industry knowledge. These positions often involve performing tests, collecting data, and ensuring products meet quality standards.

Innopharma Education – The Right Start for A Career in Quality Assurance

Innopharma Education is a leading provider of industry-focused education and training in the pharmaceutical, MedTech, and food science sectors. They offer a range of courses designed to equip students with the skills needed to excel in quality assurance roles.

If you’re interested in pursuing a career in the pharmaceutical industry, consider signing up for the Pharmaceutical Business Operations Degree and learn key topics like pharmaceutical science, facilities management, quality control, and GMP (Good Manufacturing Practices).

Innopharma Education has strong ties with leading pharmaceutical and MedTech companies, providing students with networking opportunities and potential job placements.

Get in touch today to see how Innophrama Education can help you achieve your quality assurance goals and gain the experience needed to succeed in this exciting and varied career.