Quality Specialist III

Posted 26 Feb 2019

Rockville, Maryland - United States

Req Id 188036

Details

A career is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Your role:

The Quality Assurance Unit is responsible for auditing studies at various stages to assure that they are compliant with application regulations. 

The incumbent performs audits in a scope defined by the manager. He/She understands and interprets the applicable regulations and possesses basic scientific knowledge of the audit scope. The incumbent provides an independent review or audit of data, processes and reports for the assigned audit scope. Provides guidance in regulatory interpretation to operations and QA. May act as backup to the supervisor or manager.

ESSENTIAL JOB FUNCTIONS

  • Excellent background and understanding of GLP compliance and familiarity with all aspects of FDA, EPA and applicable international regulations.
  • Excellent understanding of complex and evolving regulatory requirements and intent.
  • Assure the protocol requirements are met by auditing the protocol, raw data, data summary tables, draft and final reports associated with nonclinical studies to evaluate regulatory compliance.
  • Plan, conduct and report study-specific laboratory inspections to assess compliance with GLP regulations/industry standards.
  • Assure QA departmental inspection reports and any other supporting documentation or required records are appropriately processed and eventually archived, as appropriate.
  • Identify regulatory compliance issues and provide regulatory support to departments. 
  • Constructively interact and communicate with employees in various settings.
  • An understanding of laboratory quality assurance principles to ISO 17025 and their application as specified in the Quality Manual
  • Keep QAU and QA Management apprised of compliance issues through frequent updates.

EXPANDED JOB FUNCTIONS

  • Independently host client visits and regulatory inspections.
  • Serve as a Liaison with operations departments to support consistent practice and advice.
  • Lead and assist in planning facility audits.
  • Perform vendor/subcontractor audits.
  • Provide training and guidance to QAU personnel and others as needed.
  • Assist in the planning, development, and delivery of comprehensive GLP Training Programs as needed.
  • Able to audit genetic toxicology studies.
  • Lead and participate in departmental business, process, or general regulatory projects.

Who you are:

Minimum Qualifications:

  • Bachelor’s Degree in a Science discipline and 4+ years of experience working in quality assurance auditing in a GLP or GMP facility, OR

    8+ years of experience working in GLP regulated auditing environment in laboratory/facility in lieu of a degree

Preferred Qualifications:

  • A highly motivated and detail-oriented individual with proven organizational skills, working knowledge of a research laboratory, and proven experience in conducting detailed external and internal audits. Ability to train others within the department.
  • Professional Skills, Qualifications and Experience
  • Working knowledge of a research laboratory
  • Proven experience in conducting detailed external and internal audits, desirable.
  • RQAP-GLP, or other applicable certification or registration desirable.
  • Excellent interpersonal and verbal/written communication skills with the ability to interact with all levels of management.
  • Independently determines and develops approach to solutions.
  • Proven experience in auditing or relevant laboratory/facility setting experience.
  • Excellent computer skills in word processing, spreadsheets and database software applications, specifically MS Office (Word, Excel, PowerPoint.)
  • Work with minimal supervision and independently determine corrective actions.

Physical Attributes:

  • Pre-Employment testing requirements
  • PFT and Hep B vaccine in addition to routing physical and blood work at Occupational Health Consultants
  • Physical Requirements (PPE, lifting)
  • Ability to use respirators

What we offer: We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
 

Curious? Apply and find more information at https://jobs.vibrantm.com
 

Apply Now

Let’s stay connected

Do you want to receive company news and information about career opportunities tailored to your preferences? Sign up here. You want to check the status of your application or change your candidate profile? Enter our job portal.

Redirect

You have accessed https://www.emdgroup.com, but for users from your part of the world, we originally designed the following web presence https://www.merckgroup.com.

Let's go

Share Disclaimer

By sharing this content, you are consenting to share your data to this social media provider. More information are available in our Privacy Statement