Sr Specialist

2 weeks ago

Berkeley, United States Bayer Full time

Overview Sr Specialist - QA Discrepancy Management Berkeley, CA Purpose: Evaluate and approve incident reports (IRs) [discrepancies] and corrective and preventive actions (CAPAs) using scientific principles, thorough analysis, and compliance minded thought processes which meet cGMP requirements within established timelines. Responsibilities Represent QA in interactions with Quality Assurance, Quality Control, Technical Operations, and Supply Chain, Bayer partners, Supplier Auditors/Inspectors, regulatory agency inspectors. Review and approve incident reports and CAPAs. Ability to enter, review, query, and trend data in electronic discrepancy management systems (e.g. TrackWise). Use resources across site and across departments to assure timely investigations of high quality. You may lead teams to provide highly scientific evaluation of issues intended to mitigate business and compliance risk while maintaining product supply. Manage non-routine projects of moderate to high complexity. Provide effective leadership in training and developing internal customers/stakeholders. Support workforce diversity, quality and safety. Write and revise SOPs. Supervise and provide technical guidance to Technical Reviewers. Monitor processes and products to identify opportunities for continuous improvement. Who You Are Bayer seeks an incumbent who possesses the following: Required Qualifications Bachelors degree in a scientific/technical field; Significant experience in the biopharmaceutical, biologics, medical device or related industry, with knowledge and understanding of cGMP concepts, and applicable US and foreign regulations; Multiple years of direct experience in Manufacturing and/or Quality in a GMP-regulated industry or an equivalent combination of education and experience; Ability to understand, review and approve incident reports (discrepancies) and CAPAs; Proven ability as a team player and leader; Excellent interpersonal skills; Ability to listen and understand the opinions and perspectives of others while influencing without authority with internal and external customers/stakeholders regarding possible recommendations; Proven ability to lead cross functional teams; Ability to independently recognize opportunities and the need for business and process improvements. Ability to multitask and support changing priorities; Strong written and oral communication skills, good presentation and influencing skills; Ability to assess, investigate and resolve deviations; Strong ability to plan and prioritize complex and conflicting objectives to meet release goals and manage multiple priorities; In-depth knowledge of GMP. Preferred Qualifications Advanced degree; Over 8 years of overall experience in the biopharmaceutical, biologics, medical device or related industry, with knowledge and understanding of cGMP concepts, and applicable US and foreign regulations; Over four years of direct experience in Manufacturing and/or Quality in a GMP-regulated industry or an equivalent combination of education and experience. Location and other details Location: United States, California, Berkeley Division: Pharmaceuticals Reference Code: 856087 Contact: hrop_usa@bayer.com Bayer is an Equal Opportunity Employer/Disabled/Veterans and is committed to providing reasonable accommodations in its application process for individuals with disabilities. This posting will be available for application until at least 11-15-25. #J-18808-Ljbffr

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