All Skills Related to QA Documentation Coordinator

cGMP stands for current Good Manufacturing Practices. GMPs apply to industries that produce pharmaceuticals, food, and beverages. The FDA publishes guidances to help companies understand how they view the regulations related to drug manufacturing. Since FDA's thinking evolves, it is important to know what about the current GMPS. People who manufacture drugs for human use are expected to understand and comply with current FDA guidelines related to Good Manufacturing Practices.

Use Microsoft Office programs such as Word, Excel, and PowerPoint.  Word or another writing program would be used to prepare technical documents and write reports. Excel is used to create spreadsheets, tables, and graphs, and for data analysis. PowerPoint is used to present results.

Database skills, inventory tracking, and the ability to use a Laboratory Information Management system are also common requirements.

Ensure that manufacturing data is maintained, reviewed, analyzed, assessed, ensuring accuracy and compliance

To be detail oriented means to be able to pay attention and focus on small parts of a project.

Promptly and accurately enter information, calculate, and report results.

Companies that conduct pre-clinical research must comply with Good Laboratory Practices. In a company, GLPs are part of a quality system that covers the process and conditions under which non-clinical laboratory studies are planned, performed, monitored, recorded, reported, and archived.

Companies that manufacture substances regulated by the FDA must adhere to Good Manufacturing Practices (GMPs). Good Documentation Practices (GDP) are important in recording and managing data related to test results.

Review, document, maintain, and order laboratory supplies. Record information.

Perform mathematical calculations, including addition, subtraction, division, multiplication, ratios, and percentages. Must be able to use proportions, understand orders of magnitude, convert units, and use dimensional analysis.

To be organized means that you are able to manage your time, energy, and workspace so that you can accomplish your work. You are able to plan and prioritize tasks and keep track of work that needs to be done. 

Carry out laboratory work and field work without endangering yourself or others.

Know how to write, revise, and collaborate on technical documents such as standard operating procedures (SOPs) and analytical methods.

Accurately estimate the amount of time needed to perform one or more tasks and organize time effectively.

Analyze a problem and identify the correct solution

The FDA protects public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of the U.Ss food supply, cosmetics, and products that emit radiation. They also regulate tobacco.

Many biotechnology companies require employees to understand and know how to comply with FDA requirements. These include for Good Laboratory Practices (GLPs), Good Manufacturing Practices (GMPs), and Good Documentation Practices (GDPs). Companies that are carrying out clinical trials must also comply with Good Clinical Practices (GCPs).