Know ATS Score
CV/Résumé Score
  • Expertini Resume Scoring: Our Semantic Matching Algorithm evaluates your CV/Résumé before you apply for this job role: GCP Sr. Auditor.
United States Jobs Expertini

Urgent! GCP Sr. Auditor Job Opening In Paramus – Now Hiring 5 Star Recruitment



Job description

JOB DESCRIPTION:

  • The GCP Quality Assurance Sr. Auditor will report to the Director the GCP/PVG Quality Assurance.
  • This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Companys compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment.
  • The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits.
  • This position will provide day to day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials.
  • The Sr. Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates.

    The ideal candidate will have extensive GCP experience.
  • This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies
  • They are based in Northern New Jersey and require the candidate to be on-site.
  • Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance

RESPONSIBILITIES:

  • Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials.
  • Plan and conduct audits of specific clinical processes based on risk.
  • Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor.
  • Develop audit reports and distribute them to appropriate stakeholders.
  • Own and manage related clinical vendor non-conformances.
  • Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.).
  • Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors.
  • Support the preparation, coordination, and participation of regulatory agency inspections.
  • Participate in and support quality improvement projects.

QUALIFICATIONS:

  • 5+ years of pharmaceutical experience
  • BS degree in scientific, health care or related discipline
  • Intensive GCP and safety background
  • Experience with both internal and external process and systems audits
  • Strong knowledge of development policies, procedures and standards (SOPs, QMS)
  • Ability to work with global clinical teams in developing objectives for audits of clinical studies
  • 10% Traveling required


Required Skill Profession

Office And Administrative Support



Your Complete Job Search Toolkit

✨ Smart • Intelligent • Private • Secure

Start Using Our Tools

Join thousands of professionals who've advanced their careers with our platform

Rate or Report This Job
If you feel this job is inaccurate or spam kindly report to us using below form.
Please Note: This is NOT a job application form.


    Unlock Your GCP Sr Potential: Insight & Career Growth Guide


  • Real-time GCP Sr Jobs Trends in Paramus, United States (Graphical Representation)

    Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for GCP Sr in Paramus, United States using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 53448 jobs in United States and 20 jobs in Paramus. This comprehensive analysis highlights market share and opportunities for professionals in GCP Sr roles. These dynamic trends provide a better understanding of the job market landscape in these regions.

  • Are You Looking for GCP Sr. Auditor Job?

    Great news! is currently hiring and seeking a GCP Sr. Auditor to join their team. Feel free to download the job details.

    Wait no longer! Are you also interested in exploring similar jobs? Search now: .

  • The Work Culture

    An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at 5 Star Recruitment adheres to the cultural norms as outlined by Expertini.

    The fundamental ethical values are:
    • 1. Independence
    • 2. Loyalty
    • 3. Impartiality
    • 4. Integrity
    • 5. Accountability
    • 6. Respect for human rights
    • 7. Obeying United States laws and regulations
  • What Is the Average Salary Range for GCP Sr. Auditor Positions?

    The average salary range for a varies, but the pay scale is rated "Standard" in Paramus. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.

  • What Are the Key Qualifications for GCP Sr. Auditor?

    Key qualifications for GCP Sr. Auditor typically include Office And Administrative Support and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.

  • How Can I Improve My Chances of Getting Hired for GCP Sr. Auditor?

    To improve your chances of getting hired for GCP Sr. Auditor, consider enhancing your skills. Check your CV/Résumé Score with our free Tool. We have an in-built Resume Scoring tool that gives you the matching score for each job based on your CV/Résumé once it is uploaded. This can help you align your CV/Résumé according to the job requirements and enhance your skills if needed.

  • Interview Tips for GCP Sr. Auditor Job Success
    5 Star Recruitment interview tips for GCP Sr. Auditor

    Here are some tips to help you prepare for and ace your job interview:

    Before the Interview:
    • Research: Learn about the 5 Star Recruitment's mission, values, products, and the specific job requirements and get further information about
    • Other Openings
    • Practice: Prepare answers to common interview questions and rehearse using the STAR method (Situation, Task, Action, Result) to showcase your skills and experiences.
    • Dress Professionally: Choose attire appropriate for the company culture.
    • Prepare Questions: Show your interest by having thoughtful questions for the interviewer.
    • Plan Your Commute: Allow ample time to arrive on time and avoid feeling rushed.
    During the Interview:
    • Be Punctual: Arrive on time to demonstrate professionalism and respect.
    • Make a Great First Impression: Greet the interviewer with a handshake, smile, and eye contact.
    • Confidence and Enthusiasm: Project a positive attitude and show your genuine interest in the opportunity.
    • Answer Thoughtfully: Listen carefully, take a moment to formulate clear and concise responses. Highlight relevant skills and experiences using the STAR method.
    • Ask Prepared Questions: Demonstrate curiosity and engagement with the role and company.
    • Follow Up: Send a thank-you email to the interviewer within 24 hours.
    Additional Tips:
    • Be Yourself: Let your personality shine through while maintaining professionalism.
    • Be Honest: Don't exaggerate your skills or experience.
    • Be Positive: Focus on your strengths and accomplishments.
    • Body Language: Maintain good posture, avoid fidgeting, and make eye contact.
    • Turn Off Phone: Avoid distractions during the interview.
    Final Thought:

    To prepare for your GCP Sr. Auditor interview at 5 Star Recruitment, research the company, understand the job requirements, and practice common interview questions.

    Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the 5 Star Recruitment's products or services and be prepared to discuss how you can contribute to their success.

    By following these tips, you can increase your chances of making a positive impression and landing the job!

  • How to Set Up Job Alerts for GCP Sr. Auditor Positions

    Setting up job alerts for GCP Sr. Auditor is easy with United States Jobs Expertini. Simply visit our job alerts page here, enter your preferred job title and location, and choose how often you want to receive notifications. You'll get the latest job openings sent directly to your email for FREE!