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Job #02551

About our client Our client is a chief manufacturer of therapeutic peptides for pharmaceutical and biotech companies. The company carries out its operations from two different locations one in Brussels, Belgium and the other in Torrance, California. They produce cGMP peptides according to the most stringent regulatory requirements based on a strong quality assurance policy. Position Location Quality Control Manager Southern California Salary Highly competitive package, commensurate with experience Responsibilities 1) Coordinate testing and release of raw materials, in-process and finished product, and stability samples 2) Supervise and manage work schedules efficiently to ensure that the products are tested in a timely manner 3) Perform assigned tasks in accordance with the organization’s policies and procedures 4) Prepare schedule and track work flow (which may also require alteration due to changing priorities or needs of the company) 5) Assist staff in solving analytical and technical problems 6) Troubleshoot instruments and ensure that they are operated in accordance with the relevant SOP 7) Review data from testing (in-house and outside testing), notebooks and logbooks and inform the analysts of the required corrections 8) Ensure completion of testing in a timely manner 9) Enforce safety and cGMP regulations within the laboratory 10) Review completed batch records and release finished product 11) Ensure that the staff is properly trained and comprehends all updated SOPs and test methods 12) Write and/or update SOPs and SMMs (as needed) 13) Interact with the vendors regarding specifications of raw materials 14) Evaluate the performances of QC personnel 15) Interact with contract laboratories regarding testing of finished products and reviewing completed testing from contract laboratories in a timely manner 16) Perform related duties as assigned Requirements 1) BS with 5 years or MS with at least 2-4 years of experience (in a relevant field) 2) Knowledge of cGMP, FDA, ICH and other regulatory requirements 3) Good understanding of the operation of various laboratory equipments (including HPLC, TOC, pH meters, Karl Fischer, UV, FTIR, balances, etc.) 4) Knowledge of analytical and peptide chemistry 5) Ability to implement goals, objectives and practices for effective, efficient and cost effective management of allocated resources 6) Ability to interpret data from outside laboratories (MS, GC, ICP, AAA, peptide sequencing, etc.) 7) Ability to handle multiple projects and tasks 8) Good oral and written communication skills