Bayer Senior QA Specialist Discrepancy Management in Berkeley, CA, California
Your tasks and responsibilities
Position: Major Tasks
Represents QA in interactions with Quality Assurance,
Quality Control, Technical Operations, and Supply Chain, Bayer partners, Supplier Auditors/Inspectors, regulatory agency inspectors.
Ability to review and approve incident reports and CAPAs.
Ability to enter, review, query, and trend data in electronic discrepancy management systems (e.g. TrackWise).
Uses resources across site and across departments to assure timely investigations of high quality. May lead teams to provide highly scientific evaluation of issues intended to mitigate business and compliance risk while maintaining product supply. Manages non-routine
projects of moderate to high complexity.
Provides effective leadership in training and developing internal customers/stakeholders. Supports workforce diversity, quality and safety.
Writes and revises SOPs. Supervise and provides
technical guidance to Technical Reviewers.
Monitors processes and products to identify opportunities for continuous improvement.
Who you are
Position: Skills,... Minimum Education Bachelor's degree in a scientific/ technical field. Advanced degree is preferred. Minimum Experience Minimum 6 years of overall experience in the biopharmaceutical, biologics, medical device or related industry, along with knowledge and understanding of cGMP concepts, and applicable US and foreign regulations. A minimum of four years of direct experience in Manufacturing and/or Quality in a GMP-regulated industry or an equivalent combination of education and experience. Must be able to understand, review and approve incident reports (discrepancies) and CAPAs.
Proven ability as a team player and leader
Excellent interpersonal skills
Must be able to listen and understand the opinions and Job Details perspectives of others while influencing without authority with internal and external customers/stakeholders regarding possible recommendations
Proven ability to lead cross functional teams
The ability to independently recognize opportunities and the need for business and process improvements
The 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
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer Minorities / Females / Protected Veterans / Disabled