PRAHS

  • Senior QA Specialist - (Home-Based)

    Job Locations - | US-Remote
    Posted Date 5 days ago(5/17/2018 11:49 AM)
    ID
    2018-46919
  • Overview

    As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.

     

    At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.

     

    At PRA, borders do not create boundaries.  PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals.  Our growing workforce is comprised of over 15,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.

     
     
     

    Responsibilities

    Assist in the management of overall quality, compliance, and auditing activities to ensure compliance of operations with corporate policies, industry standards, and applicable regulations. This includes conducting a variety of audit activities which may include, but not be limited to. internal process audits, pharmacovigilance system audits, study specific audits (e.g.  investigator site, in process, pharmacy/distribution, trial master file), country office audits and audits of vendors used to support PRAHS services. 
    Provides consultation, mentoring and compliance for the organization on GxP areas (e.g. GCP, GLP, GMP, GPvP, GDP, etc.) by ensuring quality activities are performed and documented in compliance with Standard Operating Procedures (SOPs), company guidelines, and applicable regulations. Consults with PRA staff for interpretation of regulations.
    May have responsibility to support specific operations such as:
    • Clinical Pharmacology Unit
    • Bioanalytical Laboratory
    • Logistics
    • GMP Pharmacy
    • Computerised Systems

     • Supports and executes (may develop and maintain) trial oversight activities for assigned trials/indications to ensure quality in the execution of clinical trials, compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness.
    • Support pre-study activities, contributing to the review of key risks in the clinical protocol and advising clinical team members on effective mitigation strategies.
    • Ensure that selection of investigator sites balances benefits against potential risks and that rationale for decisions are well documented.
    • Monitors risks and mitigations during study execution. Prepares periodic reports assessing critical to quality parameters for the trial and reviews these reports with applicable clinical team members to evaluate pre-defined areas of risk and/or identify new areas of risk.
    • Assist in the execution of the Integrated Quality Plan (IQP), in collaboration with the QP&S IQP leader, Program Leader and Trial Oversight Managers.
    • Assist in (may lead) the preparation of Quality Working Group (QWG) meetings.
    • Assists in the development of materials for Stage Gate Review, as needed.
    • Provides ongoing compliance guidance to applicable clinical team members on an ongoing basis. Liaises with QPS Program Leads / Managers and other members of BRQC, as appropriate, to ensure interpretation alignment and consistency with guidance provided.
    • Support inspection readiness for the clinical trial, and provides support during sponsor-monitor inspections, as needed.
    • Support escalation of significant quality issues according to company policy and SOPs and in collaboration with the clinical team, and BRQC Peers, to ensure timely issue resolution.
    • May support the develop and implement Corrective and Preventative Action Plans (Self-Identified, Inspection).

    Qualifications

    • Read, write and speak fluent English; fluent in host country language required.
    • 5+ years experience working the clinical, regulatory, or quality environment within CRO/ pharmaceutical / healthcare environment.
    • Excellent verbal and written communication skills, interpersonal skills.
    • Excellent organizational skills.
    • Must possess a technical knowledge that is applicable to clinical drug development and possess the expected ability to master the needed understanding of clinical and technical areas.
    • An undergraduate degree, its international equivalent in health sciences, auditing, etc. from an accredited institution or sufficient previous experience in auditing is required.
    • Experience working within a clinical research organization.
    • Experience in Quality Assurance function is strongly preferred.
    • Clinical site monitoring, GxP quality assurance auditing, and GxP regulations.
    • Computer Systems Validation (CSV) experience.
    • Process improvement experience.

     

     To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.


    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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