For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
ProPharma is seeking a Quality Audit Specialist to join our team, providing vital support during external client audits and regulatory inspections related to Medical Information and Pharmacovigilance services. This role plays a key part in ensuring ongoing compliance with quality standards and industry regulatory requirements.

The Quality Audit Specialist will be responsible for continuous monitoring and evaluation of the quality system, driving improvement initiatives to maintain and enhance compliance. This is a fully remote position, ideal for a quality administration professional or a junior quality specialist from a background in medical devices, pharmaceuticals, or a similar regulated manufacturing environment.

• Support the Quality Manager and/or Quality Audit Lead during external client audits or regulatory inspections by creating reports, gathering documents, and supplying requested data.
• Record, track, and trend audit findings and response times.
• Review, approve, and communicate root cause and corrective action to stakeholders.
• Develop, recommend, and monitor corrective and preventive actions. Tracks documentation, as necessary.
• Collection, management, and analysis of data related to CAPAs, Deviations and quality KPIs.
• Generate and prepare reports to communicate outcomes of quality activities.
• Analyze and investigate, Deviations, and Quality Events to identify areas for improvement in the quality system.
• Perform effectiveness checks on Deviations and Quality Events to determine efficacy of CAPAs.
• Supports and facilitates eQMS activities (i.e., Document Management, QA review and approvals, Change Control assessments, etc.).

Skillset and requirements:

• Maintain up-to-date knowledge of, and ensure compliance with, Good Pharmacovigilance Practices (GVP), Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Documentation Practices
• Strong analytical skills with the ability to gather, interpret, and identify trends or anomalies in data.
• Excellent written and verbal communication skills, with the confidence and professionalism to engage effectively with stakeholders at all levels, including in challenging or high-pressure situations. Proven ability to provide constructive feedback and drive process improvements.
• Proven ability to prioritize tasks and manage data tracking, documentation, and record-keeping efficiently.
• Minimum of 2 years’ experience in a Quality Assurance role.
• Hands-on experience with audits, including preparation, participation, and follow-up.
• Solid understanding of deviation management and Corrective and Preventive Actions (CAPA).

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We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
*ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.

• Support the Quality Manager and/or Quality Audit Lead during external client audits or regulatory inspections by creating reports, gathering documents, and supplying requested data.
• Record, track, and trend audit findings and response times.
• Review, approve, and communicate root cause and corrective action to stakeholders.
• Develop, recommend, and monitor corrective and preventive actions. Tracks documentation, as necessary.
• Collection, management, and analysis of data related to CAPAs, Deviations and quality KPIs.
• Generate and prepare reports to communicate outcomes of quality activities.
• Analyze and investigate, Deviations, and Quality Events to identify areas for improvement in the quality system.
• Perform effectiveness checks on Deviations and Quality Events to determine efficacy of CAPAs.
• Supports and facilitates eQMS activities (i.e., Document Management, QA review and approvals, Change Control assessments, etc.)