Sr. Specialist - QA Discrepancy Management - Berkeley, CA

Bayer; Berkeley (CA); In loco; USD 115.000 - 173.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health care

Retirement plan

PTO

Descrizione del lavoro

Bayer in Berkeley, CA is hiring a Sr. Specialist in QA Discrepancy Management. You will evaluate incident reports and CAPAs using rigorous GMP standards to ensure timely, compliant investigations and continuous improvement across QA, QC, and operations.

The role requires collaboration across departments, leadership in training, strong written and oral communication, and the ability to manage multiple priorities while maintaining product supply and regulatory compliance.

Competenze

• Bachelor's degree in a scientific/technical field.
• Significant experience in biopharmaceuticals, biologics, medical devices or related industry with GMP knowledge.
• Direct experience in Manufacturing and/or Quality in a GMP-regulated industry.
• Ability to review and approve incident reports (discrepancies) and CAPAs.
• Proven ability to lead cross-functional teams and communicate effectively.

Mansioni

• Represent QA in interactions with QA, QC, Technical Operations, Supply Chain, Bayer partners, auditors and inspectors.
• Review and approve incident reports and CAPAs; enter, review, query and trend data in TrackWise.
• Lead teams to provide scientific evaluation of issues to mitigate risk and maintain product supply.
• Provide leadership in training internal customers and stakeholders.
• Write and revise SOPs; supervise and mentor Technical Reviewers.
• Monitor processes to identify opportunities for continuous improvement.

Conoscenze

GMP knowledge

Leadership

Cross-functional collaboration

Regulatory understanding

Communication skills

Formazione

Bachelor's degree in a scientific/technical field

Strumenti

TrackWise

Descrizione del lavoro

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

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.

YOUR TASKS AND 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.

REQUIRED QUALIFICATIONS

• 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.

PREFERRED QUALIFICATIONS

• 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.

Employees can expect to be paid a salary between $115,420.00 to $173,130.00. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc..

This salary range is merely an estimate and may vary based on an applicant's location, market data/ranges, an applicant's skills and prior relevant experience, certain degrees and certifications, and other relevant factors.

This posting will be available for application until at least 4-10-26

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

Equal Opportunity Employer Statement: Notice for U.S. Visitors: All information on this site is subject to compliance with local rule and regulations as they may vary from time to time and across different geographies, including, without limitation, U.S. Executive Orders.

Bayer is an E-Verify Employer.

Location: United States : California : Berkeley

Division: Pharmaceuticals

Reference Code: 865185

Email: [e-mail]