Pharmaceutical quality specialist
Also known as: pharmaceutical quality technician, pharmaceutical quality inspector, specialist of pharmaceutical quality, specialist of pharmaceutical quality control, pharmaceutical quality control technician, specialist of pharmaceutical quality compliance
About this occupation
Pharmaceutical quality specialists perform inspections and precision measurements in order to test and ensure the quality of pharmaceutical products. They are involved in the whole development phase of a pharmaceutical product until it is ready for the market. This includes the process of acquiring clinical trial licences, advising the pharmaceutical development staff on regulatory requirements and evaluating the content of the package leaflet and other documentation on the product. Moreover, pharmaceutical quality specialists collect and evaluate information on side effects of the product and communicate this knowledge both internally and to the relevant authorities.
A specialisation of pharmacist.
Essential skills and knowledge
- pharmaceutical products
- monitor manufacturing quality standards
- perform product testing
- biotechnology
- analytical chemistry
- laboratory techniques
- work analytically
- pharmaceutical chemistry
- pharmaceutical industry
- work safely with chemicals
- pharmaceutical technology
- controlled substances permits
Typical tasks and preparation
From the related US occupation profile Regulatory Affairs Specialists (O*NET 13-1041.07). Linked by an official crosswalk: related, not identical; details vary by country.
- Coordinate, prepare, or review regulatory submissions for domestic or international projects.
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
- Typical education (US)
- Bachelor's Degree
- Preparation
- Job Zone 4 of 5
- Interests
- Conventional, Enterprising, Investigative
Top skills: Reading Comprehension, Active Listening, Writing, Speaking, Critical Thinking, Judgment and Decision Making
US median pay: US$80,730 a year (2025), 417,070 employed. Source: U.S. Bureau of Labor Statistics, Occupational Employment and Wage Statistics.
Subjects this work relies on
How important each subject's knowledge is in the job itself, rated by people doing it (1 to 5).
- English or Literature in EnglishO*NET: English LanguageVery important (4.2)
- Government and PoliticsO*NET: Law and GovernmentVery important (3.9)
- Business Studies or EntrepreneurshipO*NET: Administration and ManagementImportant (3.4)
- Computer StudiesO*NET: Computers and ElectronicsImportant (3.2)
O*NET data describe work in the United States; requirements differ by country. This page includes information from the O*NET 31.0 Database by the U.S. Department of Labor, Employment and Training Administration (USDOL/ETA). Used under the CC BY 4.0 license. O*NET is a trademark of USDOL/ETA. CareerProof Global has modified all or some of this information; USDOL/ETA has not approved, endorsed, or tested these modifications.
Preparation needed
Job Zone Four: Considerable Preparation Needed
- Most common education (US)
- Bachelor's Degree
- Education
- Most of these occupations require a four-year bachelor's degree, but some do not.
- Experience
- A considerable amount of work-related skill, knowledge, or experience is needed for these occupations. For example, an accountant must complete four years of college and work for several years in accounting to be considered qualified.
- Training
- Employees in these occupations usually need several years of work-related experience, on-the-job training, and/or vocational training.
O*NET data describe work in the United States; requirements differ by country. This page includes information from the O*NET 31.0 Database by the U.S. Department of Labor, Employment and Training Administration (USDOL/ETA). Used under the CC BY 4.0 license. O*NET is a trademark of USDOL/ETA. CareerProof Global has modified all or some of this information; USDOL/ETA has not approved, endorsed, or tested these modifications.
Related occupations
Occupations O*NET links to this one by similar work, skills and knowledge.
- Regulatory Affairs Managers
- Compliance Managers
- Environmental Compliance Inspectors
- Government Property Inspectors and Investigators
- Compliance Officers
- Quality Control Systems Managers
- Document Management Specialists
- Coroners
- Equal Opportunity Representatives and Officers
- Customs Brokers
O*NET data describe work in the United States; requirements differ by country. This page includes information from the O*NET 31.0 Database by the U.S. Department of Labor, Employment and Training Administration (USDOL/ETA). Used under the CC BY 4.0 license. O*NET is a trademark of USDOL/ETA. CareerProof Global has modified all or some of this information; USDOL/ETA has not approved, endorsed, or tested these modifications.