Interested in science?

There are many different types of scientist roles in a laboratory working environment. I am in QC. After graduating, I immediately took on the role with very little background on pharmaceuticals, Good Manufacturing Practice or, on the guidelines on remaining in compliance with federal and international regulations.

Although degrees can give you the foundations to help start a career, specific job requirements and responsibilities are often specific to each job. In science these responsibilities can change drastically from site to site. I thought it would be helpful to share some general background on what my role as a QC scientist looks like.

A Quality Control (QC) Scientist plays a critical role in ensuring the quality and integrity of products or processes within industries such as pharmaceuticals, biotechnology, food and beverages, cosmetics, and manufacturing. Our primary responsibility is to perform rigorous testing, analysis, and evaluation of materials, products, and processes to ensure compliance with regulatory standards and internal quality requirements.

Tasks & Responsibilities Of A Quality Control Scientist

1. Testing and Analysis:

Conducting various analytical tests and measurements on raw materials, in-process samples, and finished products using specialized laboratory equipment and techniques. This includes assessing physical, chemical, biological, and functional properties to determine quality attributes.

2. Method Development and Validation:

Developing and validating analytical methods and procedures to ensure accurate and reliable testing. This involves optimizing existing methods or creating new ones to meet specific quality control requirements.

3. Documentation and Compliance:

Maintaining detailed records of all testing procedures, results, and observations in accordance with regulatory guidelines and standard operating procedures. Ensuring compliance with relevant regulations, such as Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).

4. Data Analysis and Interpretation:

Analyzing and interpreting test data, identifying trends, and making informed decisions regarding product quality and conformance. Applying statistical tools and techniques to evaluate data and ensure consistency and reliability.

5. Troubleshooting and Problem-Solving:

Investigating deviations or out-of-specification results and working closely with cross-functional teams to identify root causes and implement corrective actions. Collaborating with other departments, such as Research and Development or Manufacturing, to resolve quality-related issues.

6. Instrumentation and Equipment Maintenance:

Ensuring proper calibration, maintenance, and troubleshooting of laboratory instruments and equipment to guarantee accurate and reliable results. Adhering to instrument qualification and validation requirements.

7. Quality Systems and Process Improvement:

Participating in the development, implementation, and improvement of quality control systems, procedures, and protocols. Contributing to continuous improvement initiatives aimed at enhancing efficiency, accuracy, and compliance.

8. Regulatory Compliance and Audits:

Staying up-to-date with regulatory guidelines and requirements relevant to the industry. Assisting in internal and external audits, inspections, and compliance assessments to ensure adherence to quality standards and regulations.

9. Training and Documentation:

Providing training and guidance to laboratory personnel on proper testing procedures, equipment usage, safety protocols, and adherence to quality control practices. Developing and updating standard operating procedures (SOPs) and documentation.

10. Collaboration and Communication:

Collaborating with cross-functional teams, including Quality Assurance, Production, Research and Development, and Regulatory Affairs, to facilitate effective communication and alignment on quality-related matters. Communicating testing results, observations, and recommendations to stakeholders in a clear and concise manner.

The intensity of the job as a quality control scientist will change depending on the stages of development. As a QC scientist in early development of pharmaceuticals, my day to day changes frequently and there is always a new problem to solve. It can be monotonous, intense, and time consuming. However there are plenty opportunities to explore many aspects of scientific work, become familiar with different types of analytical testing, while also making an impact.