Sr. Specialist - QA Discrepancy Management - Berkeley, CA

Bayer•Berkeley, CA

4d•$115,420 - $173,130

About The Position

Evaluate and approve incident reports (discrepancies) and corrective and preventive actions (CAPAs) using scientific principles, thorough analysis, and compliance-minded processes that meet cGMP requirements within established timelines. The role represents Quality Assurance in cross-functional and external interactions, supports high-quality and timely investigations, and may lead teams evaluating issues to mitigate business and compliance risks while maintaining product supply. It also includes managing moderately to highly complex non-routine projects, training internal stakeholders, developing and revising procedures, guiding technical reviewers, and identifying opportunities for continuous improvement.

Requirements

Bachelor’s degree in a scientific or technical field.
Significant experience in the biopharmaceutical, biologics, medical device, or related industry, with knowledge and understanding of cGMP concepts and applicable U.S. 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 to work as a team player and leader.
Excellent interpersonal skills.
Ability to listen to and understand others’ opinions and perspectives and influence internal and external customers or stakeholders without authority.
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, 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, with knowledge and understanding of cGMP concepts and applicable U.S. 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, Supply Chain, Bayer partners, supplier auditors and inspectors, and regulatory agency inspectors.
Review and approve incident reports and CAPAs; enter, review, query, and trend data in electronic discrepancy management systems such as TrackWise.
Use resources across the site and departments to ensure timely, high-quality investigations.
Lead teams in scientific evaluation of issues to mitigate business and compliance risks while maintaining product supply.
Manage non-routine projects of moderate to high complexity.
Provide leadership in training and developing internal customers and 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.