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Quality Auditor

Company: Alpha Consulting
Location: North Wales
Posted on: May 5, 2021

Job Description:

QUALITY AUDITORNORTH WALES, NJProject Description: In partnership with the client, the Client's Quality Assurance Lead (QAL), the Quality Assurance Auditor (QAA) will support the client's quality assurance strategy across multiple studies, and/or countries. The QAA will perform audits per the client's audit/inspection and risk mitigation plans to assure adherence to Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GPV), and/or GxP (Good Manufacturing Practice, Good Distribution Practice, Good Laboratory Practice (GLP) in the conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of subjects/patients. Assesses compliance of clinical investigator sites, vendors, study activities and Country Offices (COs) processes against ICH (International Conference of Harmonization), applicable government agency regulations/guidelines, as well as the Client's policies, procedures, and industry standards. The QAA should have a comprehensive working knowledge of Quality Assurance, regulations, and auditing. This position is responsible for the execution of the global Quality Assurance (QA) audit activities on assigned studies/products/PV systems/business partners/vendors/Country Offices (CO). This role is responsible for Good Clinical Practice (GCP) and/or Pharmacovigilance (PV) oversight, and for assuring the compliance of studies and pharmacovigilance systems with the Client Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g., US FDA, MHRA, EMA, EU Directives, ICH, and National regulations). Primary Activities Include but are not limited to:

  • Prepares, conducts QA audits, generates audit reports, communicates results to the relevant client QA management and external relevant stakeholders and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable.
  • Activities include GCP and PV routine and directed (for-cause) audits of investigator sites, country offices, vendors, regulatory documents and marketing applications, business partners, third party collaborations and due diligence activities.
  • Conducts PV audits of PV systems, Country Operations, business partners and vendors Assesses compliance of audit entities against ICH (International Conference of Harmonization), Applicable government agency regulations/guidelines, as well as the Client's policies, procedures, and industry standards. The QAA should have a comprehensive working knowledge of Quality Assurance, regulations, and auditing.
  • Audit preparation (e.g., review of audit and inspection history, SOPs, industry trends, known non-compliances and relevant quality indicators and intelligence) and notification to key stakeholders, including timely scheduling of audits in consultation with auditees.
  • Interfaces with relevant stakeholders, including regulatory, clinical and development sub [1] teams, as appropriate to facilitate the execution of the audit.
  • Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the QAL.
  • Provide inspection management support as appropriate. Skills: Primary skills include but are not limited to:
    • Pharmacovigilance/Clinical/Regulatory Expertise: Broad and in-depth knowledge of the drug development process, Good Clinical Practices (GCP)/Good Pharmacovigilance Practice (GVP) Adverse Events / Safety regulations and guidelines, Awareness of industry trends and hot topics relating to GCP and PV.
    • Business Acumen/Attention to Detail: Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective.
    • Applied Therapeutic Area knowledge: Familiarity with multiple therapeutic areas a plus Autonomy: Demonstrated ability to work independently.
    • Logic and analytical skills: Use rigorous logic and methods to solve difficult problems with effective solutions.
    • Communications: Able to communicate complex information and analyses to a variety of scientific and non- scientific audiences in both verbal and written formats.
    • Leadership: Act independently to make key timely decisions with limited oversight by management. Strong ability to motivate teams to embed quality by design through the life cycle of the project.
    • Creative Thinking: Strong ability to operationalize ideas proposed; frequently engages new ideas or ways of doing things and influences creative thinking.
    • Teamwork: Strong interpersonal skills with the ability to work effectively with teams.
    • Influencing: Ability to influence and negotiate with key stakeholders.
    • Decision Making: Demonstrates good judgment and decision making.
    • Time Management: Ability to multi-task and manage time efficiently and effectively.
    • Cultural Agility: Demonstrates ability to work in a culturally diverse environment. Education/Experience: BS/BA degree in relevant area with significant experience in field and experience in the pharmaceutical industry including experience conducting a broad range of audits. Required Skills:
      • Regulations experience Pharma Experience Auditing experience
      • Bachelor's Degree- MUST
      • Remote- 100% as could be traveling to trial sites throughout the US. Traveling the US and other countries could be very enticing for candidates that may like to travel.
      • Candidate will be traveling to clinical trial sites, and some auditing remote.
      • Candidate will follow Client SOP procedure to follow the audit process. After the audit is conducted, write up the audit findings and report back to stake holders.
      • Must have excellent writing skills and communication skills.
      • Must be an independent thinker as a lean organization.
      • Ideal candidate must have 3-4 yrs. auditing experience. More of a scientific background especially clinical trials and be familiar with medical terms.
      • Pharma exp a must.
      • Microsoft office, Power Pt, Excellent communication skills.
      • Primary responsibility will be performing audits and quality oversight for the GCP, GVP and other GxP areas. This 7+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Jim: ALPHA'S REQUIREMENT #21- 01357W2 ONLY MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE#ZR#LI-JP1

Keywords: Alpha Consulting, Philadelphia , Quality Auditor, Accounting, Auditing , North Wales, Pennsylvania

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