Resume Writing for GMP Jobs
Common methods and job role description definitions.
Japanese method for workplace organization. The five S’s are seiri, seiton, seiso, seiketsu, and shitsuke or sorting, straightening, shining, standardizing, and sustaining. The picture shows a 5s organized tool system. Every tool has it’s place and if it is not there it is obvious.
A controlled document that contains validated instructions on how to perform and document the manufacture of a product.
Can also be referenced as Microbial Limit Testing. Most often it is referring to the number of bacteria living on a surface or in a substance. Photo Credit
Corrective Action Preventative Action – This is a process for correcting and preventing errors during a procedure. A corrective action may be implemented as the result of a non conformance or deviation. The corrective action may be a document change, training, or any documented activity that is designed to stop the re-occurrence of the deviation. … Read more
A technique using various sized columns and substrates to perform purification by Size Exclusion Chromatography (SEC), Cation Exchange or Affinity Chromatography. The photo shows a Protein A 5ml column that is showing signs of channeling. The darker brown colored sample can be seen seeping unevenly through the resin. When you have a channeling column you … Read more
Clean in Place – Cleaning of equipment that may be too large to move and is cleaned with a CIP skid that pipes in the required cleaning solutions and water.
Special membrane filters with a determined molecular cutoff are used to separate out unwanted water and larger molecules while retaining the desired smaller molecules to create a more concentrated and pure solution.
Computer System Validation
Enzyme-linked immunosorbent assay An example of an analytic assay that demonstrates a color change to identify an antibody reaction to a substance. Referred to as a wet lab technique.
Equipment Qualification – Validation procedure for qualifying equipment used for GMP production.