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Quality Auditor (Remote)

Gladstone, NJ | Full Time | Remote
9 Days Ago

Job Description

Position Summary:
The Senior Quality Auditor supports the audit program and clinical projects to ensure compliance with regulations and Precision procedures. 

Essential functions of the job include but are not limited to: 

  • Support the Quality Management System including SOPs, training and CAPA
  • Process and maintain documentation for controlled documents, as required
  • Develop and administer training for employees and/or consultants
  • Host client/sponsor audits and support regulatory inspections
  • Coordinate and conduct assessments of potential and contracted vendors, including vendor audits as warranted
  • Coordinate and conduct internal audits of quality systems
  • Coordinate and conduct investigator site audits
  • Coordinate and conduct trial master file audits
  • Participate on computer systems validation projects and systems change control process
  • Provide QA consultation and support to assigned project teams internally and externally
  • Support and manage reported quality issues and any associated corrective and preventive actions
  • Monitor quality systems to provide feedback on compliance risks to QA management and identify opportunities for improvement
  • Maintains Q&C trackers, databases, metrics, and files
  • Follow applicable regulations and standards, including but not limited to local regulations (US  FDA and EU), ICH, ISO and company policies and procedures
  • Additional tasks as required

Qualifications:
Minimum Required:

  • Requires two to five years of applicable experience or equivalent combination of education and experience
  • Clinical research experience in non-QA role considered (e.g., clinical research associate experience)
  • Working knowledge of GCP/ICH guidelines and FDA regulations and standards

Other Required:

  • Bachelor’s degree in a science, healthcare, or related field of study
  • Availability to travel up to 25% domestically and/or internationally

Preferred:

  • CRO, Pharmaceutical and/or Medical device experience
  • QA certification preferred (e.g., CQA, SQA, etc.)
  • Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.)

Skills: 

  • Excellent interpersonal and problem-solving skills, effective verbal and written communication, computer skills

Competencies: 

  • Working knowledge of GCP/ICH guidelines and FDA regulations and industry standards
  • Intermediate proficiency in Microsoft Word, Excel, and PowerPoint, and some knowledge of Access or similar database
  • Must possess a customer service demeanor; demonstrate collaboration and flexibility, teamwork, and a keen attention to detail
  • Ability to work independently and in a team environment
  • Ability to work with cross functional groups and management under challenging situations
  • Ability to prioritize work and handle multiple and/or competing assignments
  • Excellent verbal and written communications skills

Company Overview

  • Website precisionmedicinegrp.com
  • Headquarters HOOD COLLEGE, MD
  • Size 1,000 - 3,000
  • Founded 2012
  • Type
  • CEO MARK CLEIN
  • Revenue $50M - $200M
  • Industry Business Services
  • About precision medicine group

Skills for Quality Auditor (Remote)

The job skills required for Quality Auditor (Remote) include QA, Customer Service, SOP, ISO, Problem Solving,and Attention to Detail etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Auditor (Remote). That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Auditor (Remote). Select any job title you are interested in and start to search job requirements.

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Career Path for Quality Auditor (Remote)

The following is the career advancement route for Quality Auditor (Remote) positions, which can be used as a reference in future career path planning. As a Quality Auditor (Remote), it can be promoted into senior positions as a Quality Assurance Manager Healthcare that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Auditor (Remote). You can explore the career advancement for a Quality Auditor (Remote) below and select your interested title to get hiring information.

How to Become a Quality Auditor

If you are interested in becoming a Quality Auditor, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Quality Auditor for your reference.

Step 1 Understand the job description and responsibilities of a Quality Auditor

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Step 2 Knowing the best tips for becoming a Quality Auditor can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.

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