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Quality Assurance Release Manager

Company: Bachem
Location: Torrance
Posted on: May 4, 2020

Job Description:

Your Responsibilities The Quality Assurance Release Manager is responsible for operations related Quality Assurance activities including review and approval of GMP documents and release of GMP materials. In conjunction with the Director of Quality Assurance and VP of Quality, this individual ensures manufacture of drug substances in compliance with FDA and international regulatory requirements for research, pre-clinical, clinical and commercial Active Pharmaceutical Ingredients (APIs). Your Tasks Timely release of GMP materials Review and/or approval of technical protocols and reports Review and/or approval of quality records e.g. deviations, investigations, CAPA's Ensure GMP compliance and continuous improvement of BTO's quality system Write/review/approve standard operating procedures (SOPs), specifications, etc. Support customer & regulatory audits. Participate in responses to audit observations Review and/or approval of trending data Review and/or approval of Change Controls QA representative in project teams e.g. harmonization of systems and processes across Bachem sites, implementation of new systems or processes Your Profile Bachelor's Degree in Science related field, Chemical Engineering, Biology or equivalent Minimum of 5 years' experience in a GMP/regulated industry Minimum of 3 years in QA management position Experience in GMP manufacturing environment, Quality Assurance, Quality Control Experience with 21 CFR Parts 210, 211, ICH Q7 Experience with GMP document control Experience in both internal and external auditing Ability to work with regulatory agencies Strong technical writing skills Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Nearest Major Market: Los Angeles

Keywords: Bachem, Torrance , Quality Assurance Release Manager, Executive , Torrance, California

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