What does a quality assurance scientist do?
In a manufacturing setting, a quality assurance scientist specializes in utilizing scientific procedures in ensuring that products adhere to a company's quality standards and policies. Their responsibilities include developing quality control procedures, conducting experiments and analysis, identifying areas needing improvement, implementing solutions in problem areas, and maintaining detailed records of results. Furthermore, as a quality assurance scientist, it is essential to keep an active communication line with the quality assurance team, coordinating every step of the way for an efficient and safe workflow.
Quality assurance scientist responsibilities
Here are examples of responsibilities from real quality assurance scientist resumes:
- Manage a LIMS system for electronic entering, maintaining and retrieval of sample data and quality management.
- Manage investigation reports for equipment maintenance and calibration OOS.
- Evaluate all microbiology standard operating procedures for compliance to applicable regulations; GMP, USP, EP, and JP.
- Record results using the LIMS system and release final batches.
- Investigate when non-conformance results (OOS, OOT) are observed and document findings.
- Operate sophisticated computer-control instrument like HPLC, GC-MS.
- Conduct and support CAPA investigations and relate corrective actions.
- Experience in immunological techniques including protein assays and ELISA.
- Execute methodology for FDA regulate and non-regulate raw materials and finish products.
- Perform internal audits & coordinate FDA compliance regulate activities within HACCP procedure.
- Support investigations and implementation of corrective / preventive actions under CAPA systems.
- Conduct purity and/or impurity testing of transgenic breeding populations and experimental lines using ELISA.
- Perform HPLC analysis on finish and developmental samples, providing results under establish cycle-time requirements.
- Participate in Quality/Technical audit with various vendors of plastic tubing/bag assemblies for GMP compliance and investigations.
- Collect hazardous waste samples, and analyze concentrations of environmental hazardous materials using prescribe EPA methodologies.
Quality assurance scientist skills and personality traits
We calculated that 8% of Quality Assurance Scientists are proficient in GMP, FDA, and ISO. They’re also known for soft skills such as Interpersonal skills, Organizational skills, and Problem-solving skills.
We break down the percentage of Quality Assurance Scientists that have these skills listed on their resume here:
- GMP, 8%
Audit GMP, GLP, QC document reports, review and revised SOP and protocols to comply with FDA regulatory requirements.
- FDA, 6%
Reviewed technical documents for validation process following FDA guidelines.
- ISO, 5%
Help in the validation and qualification of the ISO 7 room for SUS2.
- Data Analysis, 5%
Performed data analysis, provided scientific interpretation of the testing results, and recommended corrective actions as applicable.
- Microbiology, 5%
Assisted with equipment qualifications in a newly renovated Microbiology Laboratory.
- CAPA, 4%
Perform Investigation, risk and gap analysis / assessment using regulatory guidance and standards to support CAPA projects.
Most quality assurance scientists use their skills in "gmp," "fda," and "iso" to do their jobs. You can find more detail on essential quality assurance scientist responsibilities here:
Interpersonal skills. To carry out their duties, the most important skill for a quality assurance scientist to have is interpersonal skills. Their role and responsibilities require that "chemists and materials scientists typically work on teams and need to be cooperative." Quality assurance scientists often use interpersonal skills in their day-to-day job, as shown by this real resume: "provided inter-departmental communications between the business units, technology teams and support teams interpersonal relations/customer service"
Organizational skills. Many quality assurance scientist duties rely on organizational skills. "chemists and materials scientists must document processes carefully when conducting experiments, tracking outcomes, and analyzing results.," so a quality assurance scientist will need this skill often in their role. This resume example is just one of many ways quality assurance scientist responsibilities rely on organizational skills: "supervised all projects assigned to the qc em/microbiology organizational unit and ensured all projects assigned were completed with accuracy and satisfaction. "
Problem-solving skills. quality assurance scientists are also known for problem-solving skills, which are critical to their duties. You can see how this skill relates to quality assurance scientist responsibilities, because "chemists’ and materials scientists’ work involves posing questions during research and finding answers through results." A quality assurance scientist resume example shows how problem-solving skills is used in the workplace: "prepared standards and sample solutions as required by the test methods. "
Time-management skills. quality assurance scientist responsibilities often require "time-management skills." The duties that rely on this skill are shown by the fact that "chemists and materials scientists usually need to meet deadlines and must be able to prioritize tasks while maintaining quality." This resume example shows what quality assurance scientists do with time-management skills on a typical day: "review analytical data in lims and review chromatographic data to ensure release of samples on time. "
Analytical skills. A commonly-found skill in quality assurance scientist job descriptions, "analytical skills" is essential to what quality assurance scientists do. Quality assurance scientist responsibilities rely on this skill because "chemists and materials scientists need to evaluate the results of experiments to ensure accuracy in their research." You can also see how quality assurance scientist duties rely on analytical skills in this resume example: "prepared analytical test methods for issuance in compliance with fda regulations. "
Communication skills. Lastly, "communication skills" is an important element of what a quality assurance scientist does. Quality assurance scientist responsibilities require this skill because "chemists and materials scientists must be able to convey information clearly in reports and presentations for both technical and nontechnical audiences." This resume example highlights how quality assurance scientist duties rely on this skill: "led the weekly quality control department meetings, facilitating qc communication and project coordination. "
The three companies that hire the most quality assurance scientists are:
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Quality assurance scientist vs. Chemist
Chemists are generally responsible for observing and investigating chemical substances to create new and safe compounds essential for practical applications. They are often grouped depending on a particular area of specialization to focus and understand the complexities of the matter. A chemist usually takes time performing research and conducting experiments to test and further improve the quality and usage of a specific chemical substance. Chemists are expected to write on their observations and findings to establish scientific results.
While similarities exist, there are also some differences between quality assurance scientists and chemist. For instance, quality assurance scientist responsibilities require skills such as "microbiology," "capa," "cfr," and "test procedures." Whereas a chemist is skilled in "chemistry," "product development," "ms," and "sample preparation." This is part of what separates the two careers.
Chemists earn the highest salaries when working in the manufacturing industry, with an average yearly salary of $75,495. On the other hand, quality assurance scientists are paid more in the manufacturing industry with an average salary of $72,744.The education levels that chemists earn slightly differ from quality assurance scientists. In particular, chemists are 4.0% less likely to graduate with a Master's Degree than a quality assurance scientist. Additionally, they're 0.7% more likely to earn a Doctoral Degree.Quality assurance scientist vs. Research and development chemist
A research and development chemist primarily works at laboratories to conduct extensive tests and experiments aiming to develop new products and technologies. Although the extent of their duties may vary, it typically revolves around conducting research and studies, observing chemical reactions, maintaining records and databases, collaborating with fellow experts, and identifying the strengths and weaknesses of existing components or mixtures. They can find employment in different areas, such as manufacturing companies, private laboratories, government agencies, and even education.
In addition to the difference in salary, there are some other key differences worth noting. For example, quality assurance scientist responsibilities are more likely to require skills like "microbiology," "capa," "lab equipment," and "cfr." Meanwhile, a research and development chemist has duties that require skills in areas such as "product development," "laboratory equipment," "synthesis," and "d chemist." These differences highlight just how different the day-to-day in each role looks.
Research and development chemists may earn a higher salary than quality assurance scientists, but research and development chemists earn the most pay in the health care industry with an average salary of $82,941. On the other hand, quality assurance scientists receive higher pay in the manufacturing industry, where they earn an average salary of $72,744.In general, research and development chemists achieve similar levels of education than quality assurance scientists. They're 0.4% more likely to obtain a Master's Degree while being 0.7% more likely to earn a Doctoral Degree.Quality assurance scientist vs. Quality control coordinator
A quality control coordinator is in charge of organizing and overseeing an organization's quality control procedures, ensuring efficiency and smooth workflow. They coordinate teams and activities, delegate tasks, conduct audits, set goals, establish guidelines, gather and analyze client feedback, and develop strategies to optimize operations. They must also conduct inspections to ensure the facility's compliance with state laws and standards. Furthermore, a quality control coordinator must monitor the progress of all operations, resolving issues promptly and efficiently while adhering to the company's policies and regulations.
Some important key differences between the two careers include a few of the skills necessary to fulfill the responsibilities of each. Some examples from quality assurance scientist resumes include skills like "microbiology," "test methods," "analytical methods," and "lab equipment," whereas a quality control coordinator is more likely to list skills in "patients," "data entry," "laboratory equipment," and "corrective action. "
Quality control coordinators make a very good living in the pharmaceutical industry with an average annual salary of $69,043. On the other hand, quality assurance scientists are paid the highest salary in the manufacturing industry, with average annual pay of $72,744.When it comes to education, quality control coordinators tend to earn lower degree levels compared to quality assurance scientists. In fact, they're 5.8% less likely to earn a Master's Degree, and 1.5% less likely to graduate with a Doctoral Degree.Quality assurance scientist vs. Quality control
As the name entails, the job of a quality control inspector is to inspect, maintain, and improve the quality and standard of products. They are responsible for ensuring the company's reputation is not damaged due to defective products or inferior manufacturing processes. This can be done by detecting and resolving the problem early on, and returning the product for repair. A quality control inspector should also notify the supervisors immediately when issues arise and coordinate with them to address the problem.
Types of quality assurance scientist
Updated January 8, 2025
