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Quality control senior scientist skills for your resume and career

Updated January 8, 2025
7 min read
Below we've compiled a list of the most critical quality control senior scientist skills. We ranked the top skills for quality control senior scientists based on the percentage of resumes they appeared on. For example, 14.1% of quality control senior scientist resumes contained qc as a skill. Continue reading to find out what skills a quality control senior scientist needs to be successful in the workplace.

15 quality control senior scientist skills for your resume and career

1. QC

Quality control is a set of instructions or procedures to ensure a manufactured product or a service is up to the highest quality standards. This set of quality control criteria are either defined by the clients or the company itself.

Here's how quality control senior scientists use qc:
  • Performed QC activities with cross-functional development teams to support in-process validation of final vaccine.
  • Support regulatory affairs in the QC section of IND filings.

2. GMP

GMP stands for Good Manufacturing Practice. It is a system that ensures that all products like food, beverages, and medicinal drugs that are produced comply with the quality standards. It helps in minimizing the risks and hazards that cannot be eliminated after the testing of final products.

Here's how quality control senior scientists use gmp:
  • Managed stability Programs while managing laboratory testing, in a fast-paced, detail-oriented GMP environment since 2003.
  • Participated in 6 company internal audits which included laboratory inspections and laboratory notebook reviews to ensure GMP guidelines were being followed.

3. ICH

Here's how quality control senior scientists use ich:
  • Established and enforced ICH guidelines and requirements of Good Laboratory Practices.
  • Finalized the corresponding reports for NDA and IND submissions and responses to CDER to meet ICH guidelines all without regulatory hold.

4. FDA

The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.

Here's how quality control senior scientists use fda:
  • Supervised laboratory audit for compliance with FDA and other regulations.
  • Participated internal and FDA laboratory inspections.

5. HPLC

Here's how quality control senior scientists use hplc:
  • Coached group members for new test methods on HPLC and GC.
  • Attended a two day hands-on training course for Waters Empower software in preparation to learn Cleaning Validation by HPLC.

6. Method Development

Here's how quality control senior scientists use method development:
  • Mentored junior analysts to apply QbD and Rick Assessment Principles to method development, validation and investigations.
  • SOP Revision, Method development and Validation.

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7. OOs

Here's how quality control senior scientists use oos:
  • Perform department investigations and assist production with investigations of sample OOS or reactor contaminations.
  • Initiated and author laboratory investigations for OOS assay validity failure or due to analyst error.

8. USP

USP, acronym for Unіԛuе Sеllіng Proposition, Unіԛuе Sеllіng Pоіnt or Unіԛuе Value Prороѕіtіоn, іѕ a fасtоr thаt dіѕtіnguіѕhеѕ a product аnd/оr ѕеrvісе from the rеѕt of thе competing brаndѕ іn the market. It ѕummаrіzеѕ thе еѕѕеnсе оf a buѕіnеѕѕ аnd therefore ѕеrvеѕ as thе guіdіng рrіnсірlе for аll mаrkеtіng еffоrtѕ.

Here's how quality control senior scientists use usp:
  • Create and revise new/old SOPs to comply with current regulations (USP, EP, and JP).
  • Keep lab personnel current with pertinent FDA-BAM, Current USP, EP, ChP, and BP microbiology testing methodologies.

9. Drug Products

A drug product is a drug that has the finished dosage form which is the final product from a pharmaceutical company bearing an active ingredient. The active ingredient is tagged along with other inactive ingredients that make the product whole in the effect that it offer to users.

Here's how quality control senior scientists use drug products:
  • Justified the settings for the specification limits of drug substances and drug products.
  • Executed stability study for Clinical development and Commercial use for Cetuximab Drug Product and Drug Substance.

10. Microbiology

Here's how quality control senior scientists use microbiology:
  • Performed testing on both raw and pasteurized milk and cream using various microbiology techniques.
  • Involved in Bioassay for Cyanocobalamin in Microbiology.

11. Elisa

An enzyme-linked immunosorbent assay or ELISA is an examination or test to measure and detect a person's specific antigen, antibodies, and protein. This type of test will identify if the sample component is infected with a relative disease or condition such as HIV infection, anemia, Zika Virus, and Lyme disease with just a single experiment.

Here's how quality control senior scientists use elisa:
  • Conducted purity and/or impurity testing of transgenic breeding populations and experimental lines using ELISA.
  • Experienced in immunological techniques including protein assays and ELISA.

12. CAPA

Here's how quality control senior scientists use capa:
  • Performed or assisted lab investigation and applied CAPA when applicable.
  • Performed Laboratory Investigations from Root Cause to CAPA.

13. SME

The term ‘small and medium-sized enterprises' is meant to describe businesses of varied sizes who fall below certain limits and targets set by various organizations, such as the World Bank and the UN. SMEs, as they are commonly known, are an important part of any economy and generally, in healthy economies, should vastly outnumber other forms of business, such as multi-level corporations, because they collectively employ more people, pay better, and produce more money.

Here's how quality control senior scientists use sme:
  • Served as a liaison with Fannie Mae's SME and solicited feedback for improvement.
  • Experienced independent contributor and Subject Matter Expert (SME) for the Quality Control Factor VIII potency assay.

14. Electrophoresis

Here's how quality control senior scientists use electrophoresis:
  • Performed Gel electrophoresis on enzyme samples using the PhastGel System.
  • Conducted restriction enzyme digest and gel electrophoresis of plasmid samples.

15. Laboratory Investigations

Here's how quality control senior scientists use laboratory investigations:
  • Initiated/performed laboratory investigations for Out of Specification/aberrant results.
  • Performed Laboratory investigations including Alert/Limit Reports and Laboratory Investigation Reports.
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List of quality control senior scientist skills to add to your resume

Quality control senior scientist skills

The most important skills for a quality control senior scientist resume and required skills for a quality control senior scientist to have include:

  • QC
  • GMP
  • ICH
  • FDA
  • HPLC
  • Method Development
  • OOs
  • USP
  • Drug Products
  • Microbiology
  • Elisa
  • CAPA
  • SME
  • Electrophoresis
  • Laboratory Investigations
  • Environmental Monitoring
  • CMC
  • Technical Support
  • Analytical Data
  • Laboratory Equipment
  • Test Results
  • Data Analysis
  • Safety Procedures
  • UV/Vis
  • QA
  • EP
  • Technical Reports
  • GC
  • Data Review
  • GLP
  • Cleaning Validation
  • Process Validation
  • Analytical Test Methods
  • Analytical Procedures
  • NDA
  • R
  • Stability Program
  • Laboratory Instruments
  • Laboratory Data
  • Stability Samples
  • Analytical Instruments
  • Contract Lab
  • TrackWise

Updated January 8, 2025

Zippia Research Team
Zippia Team

Editorial Staff

The Zippia Research Team has spent countless hours reviewing resumes, job postings, and government data to determine what goes into getting a job in each phase of life. Professional writers and data scientists comprise the Zippia Research Team.

Updated January 8, 2025

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