What does a quality control senior scientist do?
Quality Control Clerks support and facilitate various functions in the troubleshooting quality audit areas. Their primary duties include auditing and reviewing quality assurance documentation, packing slips, conducting quality inspections, and compiling data from different sources. They create reports, monitor invoices, handle several projects and develop, document, and refine various procedures and ad processes. Also, Quality Control Clerks ensure inventory security and prepare routine correspondence, memoranda, and letters. Moreover, they gather, summarize, and analyze information for KPI's useful management reviews.
Quality control senior scientist responsibilities
Here are examples of responsibilities from real quality control senior scientist resumes:
- Manage small team of 2 scientists in a GMP facility.
- Monitor data for OOS and OOT test results.
- Coach group members for new test methods on HPLC and GC.
- Review GMP data, participate in GMP investigations, participate on CAPA teams.
- Review and implement new chromatographic (HPLC, GC, and TLC) method in the lab.
- Participate in laboratory investigations for OOS results.
- Perform or assist lab investigation and apply CAPA when applicable.
- Initiate, develop and implement CAPA as part of QMS records.
- Participate internal and FDA laboratory inspections.
- Supervise laboratory audit for compliance with FDA and other regulations.
- Perform QC activities with cross-functional development teams to support in-process validation of final vaccine.
- Develop a full functioning microbiology laboratory, from design to evaluating and acquiring equipment for the laboratory.
- Maintain MSDS documentation and chemical safety reference materials.
Quality control senior scientist skills and personality traits
We calculated that 14% of Quality Control Senior Scientists are proficient in QC, GMP, and ICH. They’re also known for soft skills such as Analytical skills, Communication skills, and Math skills.
We break down the percentage of Quality Control Senior Scientists that have these skills listed on their resume here:
- QC, 14%
Performed QC activities with cross-functional development teams to support in-process validation of final vaccine.
- GMP, 9%
Managed stability Programs while managing laboratory testing, in a fast-paced, detail-oriented GMP environment since 2003.
- ICH, 6%
Established and enforced ICH guidelines and requirements of Good Laboratory Practices.
- FDA, 5%
Supervised laboratory audit for compliance with FDA and other regulations.
- HPLC, 5%
Coached group members for new test methods on HPLC and GC.
- Method Development, 4%
Mentored junior analysts to apply QbD and Rick Assessment Principles to method development, validation and investigations.
Common skills that a quality control senior scientist uses to do their job include "qc," "gmp," and "ich." You can find details on the most important quality control senior scientist responsibilities below.
Analytical skills. One of the key soft skills for a quality control senior scientist to have is analytical skills. You can see how this relates to what quality control senior scientists do because "chemists and materials scientists need to evaluate the results of experiments to ensure accuracy in their research." Additionally, a quality control senior scientist resume shows how quality control senior scientists use analytical skills: "assisted the manager in reviewing data for fda pre-approval inspections. "
Communication skills. Another essential skill to perform quality control senior scientist duties is communication skills. Quality control senior scientists responsibilities require that "chemists and materials scientists must be able to convey information clearly in reports and presentations for both technical and nontechnical audiences." Quality control senior scientists also use communication skills in their role according to a real resume snippet: "maintained close communication and interaction with qc management and staff to ensure on-time testing of samples. "
Math skills. Another skill that relates to the job responsibilities of quality control senior scientists is math skills. This skill is critical to many everyday quality control senior scientist duties, as "chemists and materials scientists regularly use calculus, algebra, statistics, and other math for calculations." This example from a resume shows how this skill is used: "applied basic math skills as required. "
Organizational skills. quality control senior scientist responsibilities often require "organizational skills." The duties that rely on this skill are shown by the fact that "chemists and materials scientists must document processes carefully when conducting experiments, tracking outcomes, and analyzing results." This resume example shows what quality control senior scientists do with organizational skills on a typical day: "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. Another crucial skill for a quality control senior scientist to carry out their responsibilities is "problem-solving skills." A big part of what quality control senior scientists relies on this skill, since "chemists’ and materials scientists’ work involves posing questions during research and finding answers through results." How this skill relates to quality control senior scientist duties can be seen in an example from a quality control senior scientist resume snippet: "performed maintenance on laboratory equipments and calibration of laboratory's dissolution testers. "
Time-management skills. While "time-management skills" is last on this skills list, don't underestimate its importance to quality control senior scientist responsibilities. Much of what a quality control senior scientist does relies on this skill, seeing as "chemists and materials scientists usually need to meet deadlines and must be able to prioritize tasks while maintaining quality." Here is a resume example of how this skill is used in the everyday duties of quality control senior scientists: "reduced method validation timelines by 67%. "
The three companies that hire the most quality control senior scientists are:
- Catalent Pharma Solutions22 quality control senior scientists jobs
- Bristol-Myers Squibb15 quality control senior scientists jobs
- Takeda Pharmaceuticals U.S.A., Inc.6 quality control senior scientists jobs
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Compare different quality control senior scientists
Quality control senior scientist vs. Microbiology analyst
A quality assurance associate's role is to oversee the production operations in a manufacturing plant or a similar setting, ensuring quality standards throughout the entire process. Most of the time, a quality assurance associate must perform workforce assessments, provide training to new employees, produce or approve documentation and progress reports, and collaborate with colleagues to ensure that everything is running smoothly and complies with the company's policies and regulations. Furthermore, there are instances when one must address issues and concerns, providing them with the necessary corrective measures.
There are some key differences in the responsibilities of each position. For example, quality control senior scientist responsibilities require skills like "qc," "ich," "method development," and "drug products." Meanwhile a typical microbiology analyst has skills in areas such as "lab equipment," "microorganisms," "laboratory procedures," and "bioburden." This difference in skills reveals the differences in what each career does.
The education levels that microbiology analysts earn slightly differ from quality control senior scientists. In particular, microbiology analysts are 12.5% less likely to graduate with a Master's Degree than a quality control senior scientist. Additionally, they're 3.8% less likely to earn a Doctoral Degree.Quality control senior scientist vs. Quality assurance associate
A quality associate is responsible for ensuring that a new product meets standards for usage and operating. You will perform various tasks that include assisting in identifying quality problems and improving operational processes, writing, disseminating, and maintaining quality documentation and manuals, and verifying logs and databases to monitor and flag quality issues and improvements. In addition, you are responsible for supporting document control and quality audits, reviewing reports and validation protocols, and investigating and diagnosing quality complaints.
In addition to the difference in salary, there are some other key differences worth noting. For example, quality control senior scientist responsibilities are more likely to require skills like "ich," "hplc," "method development," and "usp." Meanwhile, a quality assurance associate has duties that require skills in areas such as "excellent interpersonal," "customer service," "visualization," and "quality system." These differences highlight just how different the day-to-day in each role looks.
In general, quality assurance associates achieve lower levels of education than quality control senior scientists. They're 6.7% less likely to obtain a Master's Degree while being 3.8% less likely to earn a Doctoral Degree.Quality control senior scientist vs. Quality associate
There are many key differences between these two careers, including some of the skills required to perform responsibilities within each role. For example, a quality control senior scientist is likely to be skilled in "qc," "gmp," "ich," and "method development," while a typical quality associate is skilled in "patients," "quality system," "quality specifications," and "product quality."
Quality associates typically earn lower educational levels compared to quality control senior scientists. Specifically, they're 12.5% less likely to graduate with a Master's Degree, and 3.6% less likely to earn a Doctoral Degree.Quality control senior scientist vs. Team lead for quality control
Types of quality control senior scientist
Updated January 8, 2025
