Sr Specialist

1 week ago

Berkeley, CA, 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.

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