Senior QA Specialist I

Our Work Matters

AtKindeva we make products that save lives ensuring better health and well-being for patients around the world.

The Impact You Will Make: As a Senior Quality Assurance Specialist I you will play a pivotal role in ensuring the highest standards of product quality and regulatory compliance. You will provide leadership and technical expertise to the QA team while driving quality improvement initiatives across the organization. Your contributions will directly support the delivery of safe effective and compliant pharmaceutical solutions by mentoring team members managing quality risks conducting audits and using data to inform decision-making and continuous improvement.

Responsibilities:

Team Leadership & Mentorship

• Mentor and coach QA team members to enhance technical skills and professional development.
• Provide guidance on complex quality issues and foster a culture of continuous learning and improvement.

Technical Support & Oversight

• Serve as a subject matter expert (SME) for quality systems processes and regulatory requirements.
• Support cross-functional teams with technical guidance on quality-related matters.
• Triage deviations for impact assessment and next steps.
• Support deviation writing and management.
• Support and manage the Supplier Quality Management Program.

Quality Improvement Initiatives

• Lead and implement quality improvement projects to enhance product quality and operational efficiency.
• Identify process gaps and recommend corrective and preventive actions (CAPAs).

Risk Management

• Proactively identify and assess quality risks across the product lifecycle.
• Develop and implement risk mitigation strategies in collaboration with relevant stakeholders.

Data Analysis & Reporting

• Analyze quality data to identify trends root causes and areas for improvement.
• Prepare and present quality metrics and dashboards to senior leadership.
• Draft and compile Annual Product Review (APR) reports in compliance with regulatory and internal requirements.
• Coordinate with manufacturing regulatory and R&D teams to gather and validate data.

Audits & Inspections

• Plan conduct and support internal and external audits including supplier audits and regulatory inspections.
• Ensure timely closure of audit findings and implementation of corrective actions.

Qualifications:

• Bachelors degree in Life Sciences Engineering or a related field (Masters preferred; experience may be substituted for education).
• Minimum 7 years of experience in Quality Assurance within the pharmaceutical biotech or medical device industry.
• Strong knowledge of GMP FDA ISO and other relevant regulatory standards.
• Proven experience in mentoring and leading QA teams.
• Excellent analytical problem-solving and communication skills.
• Proficiency in quality management systems (QMS) and data analysis tools.
• Qualified to work with controlled substances

Preferred Skills:

• Certification in Quality (e.g. ASQ CQE CQA) is a plus.
• Experience with electronic QMS platforms.
• Familiarity with Lean Six Sigma or other continuous improvement methodologies.

Additional Qualifications:

• Good organizational skills and attention to detail.
• Ability to build and maintain positive relationships with management and peers.
• Must be flexible adaptable self-motivated and able to work well independently and with cross-functional teams.
• Ability to change priorities in response to company demands while continuing to deliver results.
• Ability to assess problems identify solutions plan and implement necessary changes.

Physical Requirements:

• Specific vision requirements include close vision distance vision color vision and the ability to adjust and focus in order to read understand and execute documentation as required.
• Employee is required to follow all cGMP and safety procedures.
• Must wear required safety equipment and safely perform work.
• Must use proper lifting techniques and remain aware of environmental hazards.
• Must occasionally lift and/or move up to 20 pounds.