This position provides daily management of the Quality Assurance functions as applicable to the external services contract filler by maintaining daily quality presence in their facility. This contact may be remote or on-site as needed. The position will ensure the contract filler's personnel are properly trained in cGMPs and processes and procedures applicable to Biotest's products. They will ensure prompt initiation and follow up of investigations at the contract filling sites related to deviations and out of trend data by facilitating root cause analysis, risk assessment, product impact assessment and completion of resulting CAPAs. Review and approve all standard operating procedures used in manufacturing and quality control. This position therefore will require 50% or more travel in a month. The position will also perform audits of the contract facilities which test and distribute raw materials, intermediates, and bulk materials for Biotest to ensure that products and their associated validation and stability data meet specifications.
This position requires individuals who are detailed oriented with excellent written and verbal communication skills. They need to have an understanding of plant utilities, Federal guidlines (21 CFR), and Biotest's and/or contractor's internal SOPs. There will be heavy use of word processing, speadsheets and flowcharting on Microsoft applications.
A Bachelor's degree in Biological Sciences, Chemistry, Biochemistry, Chemical Engineering or a related field is required. A minimum of seven years in quality assurance or corporate quality related function. Experience with Good Manufacturing Practices in a plasma or biologics pharmaceutical production plant is a plus.