Quality Assurance & Control

If you like working independently and knowing exactly what needs to be done and how to do it, this may be the career for you. You must have a strong sense of ethics and be able to stand your ground without antagonizing the team.

Typical Job Functions

Quality management activities are those that ensure that a company’s processes and products are up-to-code and meet all of their requirements. Quality assurance (QA) prevents and detects quality problems. Quality control (QC) detects errors in the product.

Quality Assurance

QA ensures that development and/or maintenance processes are adequate for a system to meet its objectives. Typical duties include:

• Develop and validate methods for analyzing and producing products to ensure they meet specifications; document those methods in standard operating procedures (SOPs) and production records
• Assist quality control staff with troubleshooting and resolving unusual problems
• Develop quality metrics and assess trends for product or process implications
• Develop and implement improvements to existing sample and data analysis techniques
• Evaluate current processes and identify ways to save time and money without sacrificing product quality
• Investigate product, and process deviations, identify root cause, and develop corrective and preventative actions
• Participate in audits by customers and regulatory agencies; respond to customer complaints

QA work is most often conducted in an office and involves a lot of documentation.

Quality Control

QC evaluates the developed product itself. Another way to look at it would be to think of QA as preventing and detecting quality problems and QC as detecting errors in the product. Typical duties include:

• Set up, troubleshoot, and maintain equipment
• Prepare samples in accordance with SOPs
• Conduct analytical tests on materials and finished products, following specific protocols
• Provide timely and high-quality data reports that document test results
• Test products for long-term stability or stability under various conditions

QC work is usually conducted in a laboratory setting, often under specific environmental conditions. Occasionally, sample collection or troubleshooting may require trips to the plant.

Career Paths

There are two general tracks in quality work: remaining an individual contributor, or moving into management. While both contribute to their departments, managers add supervisory responsibilities and can move up the administrative path.

Getting Started

For both QA and QC, a bachelor’s degree in a related field is typically required. An advanced degree can be useful for positions with more supervisory responsibilities. Useful background and experience include:

• General knowledge of chemistry
• Strong analytical technique and instrumentation skills
• Familiarity with guidelines for laboratory practices, manufacturing processes, and clinical practices
• Familiarity with ISO (International Standards Organization) 9000