Sr Specialist - QA Discrepancy Management - Berkeley, CA

Bayer•Berkeley, CA

14d•$115,420 - $173,130•Onsite

About The Position

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice. Sr Specialist - QA Discrepancy Management - Berkeley, CA 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.

Requirements

Bachelor’s degree in a scientific/ technical field
Significant experience in the biopharmaceutical, biologics, medical device or related industry, along 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
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 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

Nice To Haves

Advanced degree
Over 8 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
Over four years of direct experience in Manufacturing and/or Quality in a GMP-regulated industry or an equivalent combination of education and experience

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. Manages 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