Senior Quality Specialist

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. As the world’s largest RCO (Research Consulting Organization), 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.Position overviewThe Quality Specialist position supports the delivery of Medical Information and Pharmacovigilance services, to assure ongoing compliance with quality and industry regulatory requirements. The Quality Specialist performs improvement activities through continuous monitoring and evaluation of the quality system to ensure ongoing maintenance.Essential FunctionsRetrospectively evaluates telephone skills and case reports to ensure compliance standards are met and maintained.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.Review, approve, and communicate root cause and corrective action to stakeholders.Develop, recommend, and monitor corrective and preventive actions.Collection, management, and analysis of data related to CAPAs, Deviations and quality KPIs.Record, track, and trend audit findings and response times.Support the Quality Manager during external client audits or regulatory inspections by creating reports, gathering documents, and supplying requested data.Perform effectiveness checks on Deviations and Quality Events to determine efficacy of CAPAs.In conjunction with the Quality Manager, conducts routine Pharmacovigilance audits.Supports and facilitates eQMS activities (i.e. Document Management, QA review and approvals, Change Control assessments, etc.)Other duties as neededSkills required University/Bachelor’s
degree and/or or appropriate relevant work experienceMinimum 3-5 years’ experience working in a Quality Assurance roleExposure to Deviation’s; CAPAs; supporting or conducting audits would be preferredStrong stakeholder management skills are a mustHappy to work remotely but some travel to ProPharma sites maybe required when criticalThorough, dedicated and detail orientatedWe 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.***Join Our Talent CommunityDon’t see an open opportunity that matches your qualifications? Join our talent community to stay connected for potential future opportunities. Upload your resume/CV and contact details for our Talent Acquisition team to review and match for potential future opportunities. While you are here, sign up for Job Alerts to receive alerts of future opportunities that match your selected interests.Language PreferencesTo change the language, click on "English" at the top right corner of the screen and select your preferred language. If you are already signed in, click the cloud icon and go to Change Language.Tips to Avoid Recruitment FraudProPharma will never ask you for any bank account information, financial information, or another form of payment to be considered for a role. Additionally, the ProPharma talent acquisition team will only use their work email addresses (
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or any other email account, it’s likely a fraud.Current ColleaguesAre you currently a ProPharma colleague? To be considered for an opportunity, please apply through the Jobs Hub in Workday.
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