ProPharma Group
ProPharma Group

60 Propharma Group Medical Monitor Jobs Hiring Near You

... medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable ... ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone ...

... medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable ... ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone ...

... medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable ... Represents the QC group on study teams and on cross-functional project teams as needed. * Other ...

... medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable ... ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone ...

Showing results 41-60

Quality Specialist

ProPharma Group

Charleston, WV • On-site, Remote

Full-time

Posted 7 days ago


Job description

For the past 25 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.

Essential Functions:
  • Maintain awareness of, and ensure compliance with, theGxPguidelines and regulations relevant to the services provided.

  • Supports and facilitates eQMS activities (i.e., Change Control, Deviations, Quality Events (QEs), CAPAs, Effectiveness Checks, etc.)

  • Develop, recommend, andmonitorDeviations,QEsand CAPAs. Review, approve, and communicate root cause and CAPAs to stakeholders.

  • Perform effectiveness checks on Deviations and QEs todetermineefficacy of CAPAs.

  • Participate inGxPchange management activities including risk and impact analysis review, change plan review and approval, action plan implementation, andtracking tocompletion, as applicable.

  • Support client audits and regulatory inspections processes (including questionnaires):

  • Coordinate and finalization of agenda, document provision; ensuring internallogisticsand Subject Matter Expert (SME) are in place.

  • Coordinate and manage audit CAPA responses including developing responses to CAPAs with support from relevant internal SMEs.

  • Track audit and inspection records in eQMS to closure.

  • Ensuring audit information ismaintainedand stored in eQMS.

  • Generates and prepares reports to communicate outcomes of quality activities.

  • Analyzes and investigates Deviations and QEs toidentifyareas for improvement in the quality system.

  • Collection, management, and analysis of data related to CAPAs, Deviations, QEs, and quality KPIs.

  • Medical Informationspecific:

  • Retrospectively evaluates telephone skills and case reports to ensure compliance standards are met andmaintained.

  • Other duties as needed.

Necessary Skillsand Abilities:

  • Fluent in English speaking and writing.

  • Knowledge and experienceinworking with GXP Quality Management Systems.

  • Proficient computer skills, including Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).

  • Exceptional organization, prioritization, projectmanagementand delegation skills; able to multitask.

  • Excellent attention to detail and focus on quality.

  • Excellent verbal, written, and interpersonal communication skills with the ability toestablishstrong professional relationships with quality and internal staff, and with clients.

  • Exceptional customer service skills within quality and internal staff, and with clients.

  • Ability to build positive collaborations with other departments and be open to change.

  • Works in a professional manner with clients, teammembersand management.

  • Flexible and proactive toward changing needs.

  • Proactive with the ability to work with minimal supervision.

#LI-JB1

#LI-REMOTE

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.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***