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Job Description:

We are seeking a Senior QA Analyst – Technical QA to join our Quality Assurance team. In this role, you will provide QA oversight for the qualification and validation lifecycle of equipment, computerized systems, utilities, facilities, lab instruments and environmental conditions within our pilot plant and QC laboratories. We are looking for a highly motivated, independent professional with strong technical expertise, a quality mindset, and the ability to collaborate effectively across functions to ensure compliance with GMP requirements.

Key Responsibilities

• Provide Quality Assurance oversight for the qualification, validation, and lifecycle management of equipment, computerized systems, utilities, facilities, lab instruments and environmental controls supporting manufacturing and laboratory operations.
• Review and approve validation deliverables, including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols, reports, and periodic review assessments
• Ensure compliance with GMP requirements by supporting and overseeing quality events, investigations, change controls, risk assessments, and corrective and preventive action (CAPA) activities.
• Serve as the Quality representative on cross-functional teams, providing strategic QA guidance and contributing to site-wide initiatives, projects, and continuous improvement efforts.
• Apply quality, scientific, and engineering principles to assess risks, solve complex technical and compliance challenges, and support informed decision-making.
• Collaborate with stakeholders across Manufacturing, Facilities, Engineering, Validation, QC, and IT to drive compliant implementation and lifecycle management of GMP systems and processes.
• Contribute to inspection readiness and support internal and external audits, regulatory inspections, and quality assessments.
• Identify opportunities to simplify, harmonize, and improve qualification, validation, and quality processes.

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The anticipated base pay range for this position is:

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.