QA Validation specialist Berkeley, CA

At Bayer we believe work should matter. Every day our teams push toward a future where Health for all Hunger for none is within reach and every role from the lab to the field to the boardroom helps us get there. We give people the ownership to shape outcomes the support to grow through new skills and experiences and a global community where different perspectives are valued. If you want your work to count and the room to become your best youll find it here.

QA Validation specialist - Berkeley CA

Provides specialized knowledge and technical support in quality assurance and control processes within the organization; as a QA Validation Specialist you analyze quality and validation data develop best practices and advise cross-functional teams on compliance with industry standards and regulations; you collaborate with Manufacturing Engineering IT and Quality to implement quality and validation improvement initiatives conduct training sessions and ensure that all products and processes align with established quality and compliance benchmarks within a GMP-regulated environment.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role QA Validation Specialist are to:

• Provide manufacturing support as a subject matter expert delivering QA oversight for qualification and validation of manufacturing processes facilities utilities equipment and technical systems;
• Serve as subject matter expert for validation lifecycle requirements 21 CFR Part 11 ICH guidelines and risk-based qualification approaches ensuring alignment with current regulations and industry trends;
• Review and approve qualification and validation documentation for systems and processes including impact assessments URS risk assessments traceability matrices IQ OQ PQ data migration activities and related SOPs;
• Maintain and continuously improve the site validation program and associated procedures including Validation Plans Validation Master Plans and Validation SOPs to align local practices with corporate and regulatory expectations;
• Identify compliance issues conflicting requirements inefficiencies or improvement opportunities in procedures and practices; lead discussions and drive remediation activities to completion;
• Provide QA oversight of SOPs for technical systems and operations approve SOPs and influence internal partners on best practices compliant processes and high-quality documentation;
• Resolve and approve validation discrepancies participate in investigations related to validation failures and assess changes to technical systems for validation and quality impact;
• Utilize in-depth knowledge of GMP quality systems to assess critical issues understand validation impact on product quality and quality system elements and represent the site validation program and strategy during internal and external audits;
• Provide project team leadership by planning and facilitating team activities supervising contractors as needed and partnering cross-functionally to define effective approaches to accomplishing validation-related tasks;
• Work independently on problems of complex scope exercise sound judgment in selecting methods and techniques and propose new strategies to streamline computerized system validation and related processes.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Bachelors degree in a scientific or technical discipline such as Pharmacy Chemistry Biology Engineering or a related field;
• Several years of hands-on experience typically 5 years in GMP-regulated pharmaceutical biotech or medical device operations with a focus on validation and quality assurance;
• Strong expertise in validation lifecycle activities for manufacturing processes facilities utilities equipment and computerized systems including URS development risk assessments IQ/OQ/PQ execution and periodic review of validation status;
• In-depth knowledge of relevant regulatory requirements and guidelines such as FDA 21 CFR Part 11 and Parts 210/211 ICH guidelines data integrity principles and industry standards including GAMP 5;
• Demonstrated experience reviewing authoring and approving validation protocols reports SOPs risk assessments and traceability matrices with high attention to detail and compliance;
• Solid understanding of QA systems including change control deviation and discrepancy management CAPA and audit/inspection readiness as they relate to validation activities;
• Strong analytical and critical-thinking skills with the ability to work on complex problems evaluate multiple factors and make sound timely decisions that balance quality compliance and business needs;
• Excellent interpersonal and communication skills with the ability to influence and collaborate effectively across Manufacturing Engineering QA IT and project teams in a diverse multidisciplinary environment.

Preferred Qualifications:

• Advanced degree in a relevant scientific or engineering discipline such as an MS or PhD;
• 810 years of experience in validation quality assurance or computerized system validation roles within large-scale pharmaceutical or biotech manufacturing environments;
• Experience acting as a site or program validation lead for major initiatives such as new facility start-ups technology transfers large system implementations or significant process changes;
• Formal training or certifications in Computerized System Validation Quality Assurance Six Sigma or Project Management;
• Deep practical experience with technical systems such as MES LIMS process control systems (DCS/PLC/SCADA) data historians and ERP platforms like SAP particularly in the context of validation and data integrity;
• Experience presenting validation strategies and outcomes during regulatory inspections or corporate audits and developing and delivering training on validation principles SOPs and best practices to cross-functional teams.

Employees can expect to be paid a salary between $117760.00 - $176640.00 . 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 applicants location market data/ranges an applicants skills and prior relevant experience certain degrees and certifications and other relevant factors.

This posting will be available for application until at least.

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