Role Responsibilities:

• Manage the receiving and handling (intake, triage, follow-up, product returns, investigation, and reconciliation) of Product Quality Complaints in a manner that complies with global regulatory requirements.
• Support users with investigations/deviations, CAPA, and change controls programs, including final review and approval.
• Ensure thorough root cause evaluation and implementation of effective corrective actions.
• Facilitate Quality Risk Assessments.
• Support audits of service providers.
• Provide assistance to the front and back rooms during cGMP compliance inspections.
• Provide organizational training and support.
• Support computer system validation efforts for implementing changes to the eQMS.
• Identify and implement continuous improvement opportunities.
• Support the Quality Management Review.
• Regularly generate metrics and communicate (e.g., trends, process) for their effectiveness and provide feedback to the Quality Systems team for action and remediation.
• Maintain compliance with applicable regulatory and company documentation standards.
• Actively collaborate with QC, Manufacturing, Regulatory, and Supply Chain functions.
• Ability to navigate, integrate, and troubleshoot cross-platform data for QA use cases.
• Completes assigned training on-time.
• Other duties as assigned.

 Qualifications:

• Bachelor's degree in a science, technology, engineering, or mathematics.
• Bachelor’s degree in a STEM field with 3-5 years of industry experience.
• Experience supporting CAPA, Deviations/Investigations, Change Controls, and/or Product Complaints processes as a quality partner.
• Experience working with manufacturing sites and 3PLs in a Quality oversight role.
• Knowledge of cGMPs.
• Proactive in identifying opportunities with a robust, solution-minded approach and flexibility to emerging challenges.
• The ability to comprehend regulations and guidance documents, apply critical thinking skills to evaluate requirements, and effectively communicate written and oral findings.

If you’re the right fit, please submit your resume or CV using the email link below.

Apply