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Job #02561

About our client Our client is a biopharmaceutical manufacturer servicing virtual biotech companies with minimal infrastructure. The company is proficient in developing peptides for clinical trials. It is an expert in the area of FDA documentation and regulatory support. The company is committed to producing the lowest worldwide cost-of-goods for raw materials as well as building blocks and mass cGMP peptide manufacturing. Position Location Quality Control/Validation Chemist Georgia Salary Highly competitive package, commensurate with experience Responsibilities 1) Perform various tasks such as receiving raw materials, quarantine, sampling, testing, releasing and inventory 2) Control final products and manage product storage and inventories 3) Handle final product sampling, testing and packaging 4) Write SOPs, Standard Test Procedures (STPs), Master Batch Record (MBR) and other related GMP documents 5) Develop and validate analytical methods 6) Assist in coordinating and maintaining validation program 7) Handle development of system reviews for validations with the QC Manager 8) Participate in writing and executing equipment/instrumentation qualification protocols and validation protocols 9) Coordinate and participate in technical project activities (as required) to support manufacturing and quality operation 10) Participate in writing and executing product specific Stability Protocol 11) Perform stability studies of APIs and API intermediate 12) Follow approved GMP manufacturing directions such as MBR, SOPs, STPs and other procedures to perform testing and package products, including other related activities 13) Operate and maintain equipments, including LC-MS, HPLC, Karl-Fischer, Melting Point Apparatus, balance and other analytical equipments 14) Ensure SOPs and approved directions are followed for cleaning equipment and glassware used in QC Department 15) Maintain cleaning logs for all equipment 16) Ensure compliance of maintenance and cleaning procedures of equipment and instruments used in QC Department 17) Review and sign off on maintenance and cleaning logs periodically 18) Maintain and follow GMP Documentation System 19) Investigate any deviation and write process deviation report 20) Initiate document change request 21) Coordinate with the Contractor to calibrate equipment used for GMP manufacturing, QC and storage 22) Assist Quality Assurance Unit in maintaining equipment calibration program Requirements 1) BS in Chemistry or equivalent degree 2) 3 – 5+ years of performance in the biotech or pharmaceutical industry environment 3) Experience in and knowledge of cGMP requirements for drugs 4) Extensive analytical method experience, including HPLC, GC/Headspace Sampler, Karl-Fischer, conductivity, pH and other general laboratory instrumentation 5) Drug manufacturing experience preferred