Quality Assurance

Quality management activities are those that ensure that a company’s products are exactly what they are supposed to be, that is, they meet all their specifications. Quality assurance (QA) and quality control (QC) are two of the main activities that are required to ensure a quality product. QA and QC are closely related, but they are different concepts. QA is a set of activities that ensures that development and/or maintenance processes are adequate in order for a system to meet its objectives, whereas QC is a set of activities designed to evaluate the developed products. Another way to look at it would be to think of QA as preventing and detecting quality problems and QC as detecting errors in the product.
Chemists who work in quality assurance enjoy finding ways to reduce the possibility of error in manufacturing methods by using a big-picture view of product quality.

Typical Quality Assurance Duties

  • Develop and validate methods for analyzing and producing products to ensure they meet specifications and document those methods in standard operating procedures (SOPs) and production records.
  • Audit quality control, production and sales functions, and other records to ensure compliance with SOPs.
  • Assist quality control staff with troubleshooting and resolving unusual problems.
  • Develop quality metrics and assess trends for product or process implications.
  • Develop and implement improvements to existing sample and data analysis techniques.
  • Critically evaluate current processes and continually identify ways to save time and money without sacrificing product quality.
  • Investigate product, and process deviations, identify root cause, and develop corrective and preventative actions.
  • Participate in audits by customers and regulatory agencies and respond to customer complaints.

Technical Skills

  • Familiarity with guidelines such as good laboratory practices, good manufacturing processes, and good clinical practices (collectively known as GXPs), as well as ISO (International Standards Organization) 9000, is helpful.
  • Meticulous attention to detail, excellent organizational skills, and investigative abilities for when a problem arises.
  • Technical writing skills are essential.
  • Ability to prioritize multiple projects and deadlines.
  • Good interpersonal skills, including tact, diplomacy ,and negotiation skills for resolving compliancy issues.
  • Unwavering integrity.
  • Good judgment and decision-making skills.

Career Path

As long as there are regulations, there will be a need for people to make sure they are being followed. Over time, quality assurance professionals generally move up to larger projects with more responsibilities and rewards, which may include learning the regulatory landscape in other countries. Eventually, they may move away from day-to-day operations and into more strategic planning positions, where they are looking at the bigger picture of quality.

Original content at acs.org


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