Our client is looking for a Technical Writer to assist with analytical validation report writing. The position would focus on authoring analytical methods, data, validation, and analytical method validations. The analytical method validations would be relative to sterile manufacturing processes (HPLC, GC, MS, etc.). The role would also include reviewing batch records, validation protocols, cleaning protocols and assisting with related technical transfer efforts in correlation with analytical method & validation technical writing. This candidate should have at least 5-10 years of experience in FDA related industry (pharma/bio). They also prefer a candidate that is well versed in Qualification Regulations such as ICH guidelines and ISO accreditation.
Candidates must display attention-to-detail, excellent technical writing skills, and a technical GMP understanding. Previous experience working directly with CDMO’s will be beneficial.
Analytical method/validation technical writing
NJ: Analytical Validation Technical Writer (234148)