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Job #03097

About our client Our client is a leading producer of therapeutic peptides for pharmaceutical and biotech companies. Our client operates from two locations – in Brussels, Belgium and in Torrance, California. They are committed to serving the pharmaceutical and biotech industries with the production of cost-effective and high-quality bulk peptide APIs based on close and long-term relationships with customers. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Quality Assurance Associate Torrance, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Function as primary support person to the QA Manager in all areas of QA duty 2) Maintain expertise in current FDA regulations and ICH guidelines applicable to APIs 3) Manage the accurate and timely execution of all aspects of the QA Department 4) Ensure GMP compliance throughout the company 5) Liaise with customers and FDA officials during audits (as needed) 6) Review and approve all related documents in QA/QC/Production (data from testing in-house and outside testing), notebooks, log books, finished product data files, raw material release files, etc. 7) Generate, maintain and control all related SOPs 8) Write ‘chemistry manufacturing control’ documentation packages for customer filings and drug master files (as needed) 9) Carry out tasks as per organization’s policies and procedures 10) Enforce cGMP regulations within the laboratory 11) Ensure that staff is properly trained as well as comprehends all updated SOPs and test methods 12) Oversee internal audits 13) Address and troubleshoot potential issues that may arise during the project execution 14) Confirm client directives are executed accurately and consistently 15) Ensure that final reports released and delivered to clients comply with verbal/written instructions 16) Confirm receipt of final reports by clients 17) Assist Production Department and VP of Operations in prioritization of schedules (as required) 18) Oversee hiring and evaluating the performances of all QA personnel (as required) 19) Oversee cGMP training of employees 20) Perform related duties as assigned Requirements 1) MS 2) Minimum 8+ years of QA experience 3) Proficient in current cGMP, FDA, ICH and other regulatory guidelines 4) Good communication skills (oral and written) 5) Ability to analyze problems, identify alternative solutions and implement recommendations for resolution of problems 6) Demonstrated ability to handle multiple projects and tasks 7) Ability to implement goals, objectives and practices for effective, efficient and cost effective management of allocated resources 8) Ability to work in a team