Recruiter's Glossary

Examples: Spectroscopy • Process Control • Qualification

QA/QC

Term from Pharmaceutical Services industry explained for recruiters

QA/QC stands for Quality Assurance and Quality Control, which are essential functions in pharmaceutical companies to ensure medicines and medical products are safe and meet all required standards. While often used together, QA focuses on preventing quality problems by setting up proper procedures, while QC involves testing and checking products to make sure they meet quality standards. Think of QA as creating the recipe and rules for baking bread, while QC is actually testing the bread to make sure it turned out right. Similar terms used in the industry include Quality Management, Quality Systems, or Quality Operations.

Examples in Resumes

Led QA/QC department of 15 people ensuring compliance with FDA regulations

Performed Quality Assurance testing on new pharmaceutical products

Managed Quality Control laboratory operations and documentation

Implemented new QA procedures that reduced error rates by 25%

Conducted QC testing for raw materials and finished products

Typical job title: "QA/QC Specialists"

Also try searching for:

Quality Assurance Specialist Quality Control Analyst QA Manager QC Manager Quality Systems Specialist Quality Operations Manager Quality Compliance Specialist Quality Assurance Associate

Where to Find QA/QC Specialists

Professional Organizations

Online Communities

Job Boards

Example Interview Questions

Senior Level Questions

Q: How would you handle a situation where you discover a major quality issue in a batch of products that has already been shipped?

Expected Answer: A senior QA/QC professional should explain the proper recall procedures, regulatory reporting requirements, root cause investigation process, and corrective action planning. They should emphasize documentation, communication with stakeholders, and preventing future occurrences.

Q: How do you stay current with FDA regulations and ensure your team maintains compliance?

Expected Answer: Should discuss methods for tracking regulatory updates, implementing training programs, conducting regular audits, and maintaining quality management systems. Should mention experience with creating SOPs and quality manuals.

Mid Level Questions

Q: What is the difference between quality assurance and quality control?

Expected Answer: Should explain that QA is preventive and focuses on processes and procedures to prevent defects, while QC is detective and involves testing products to find defects. Should provide practical examples from pharmaceutical manufacturing.

Q: How do you document and investigate out-of-specification (OOS) results?

Expected Answer: Should describe the standard investigation process, including initial assessment, documentation requirements, root cause analysis, and corrective action implementation. Should emphasize the importance of thorough documentation.

Junior Level Questions

Q: What are SOPs and why are they important?

Expected Answer: Should explain that Standard Operating Procedures (SOPs) are detailed written instructions that describe how to perform specific tasks, and they ensure consistency and compliance in pharmaceutical operations.

Q: What is GMP and why is it important in pharmaceutical manufacturing?

Expected Answer: Should explain that Good Manufacturing Practice (GMP) is a system of basic rules that ensure products are consistently produced according to quality standards, protecting patient safety.