Quality Assurance (QA) Associate

Location
Remote
Salary
Competitive
Posted
May 24, 2022
Closes
Jun 07, 2022
Ref
3401
Function
Other
Industry
Science
Hours
Full Time
Quality Assurance (QA) Associate

US Remote Worker

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

Responsible for conducting internal and participating in external audits/inspections and completing vendor qualification and management processes. Responsible for continually monitoring for laws, regulations, policies, etc. to ensure compliance across the board.

Responsibilities
  • Conduct internal audits for each study
  • Assist in vendor audits
  • Serve as the point of contact for external audits/inspections
  • Develop company policies and procedures (including but not limited to SOPs) with oversight from the Quality and Compliance Manager
  • Develop Trial Master File (TMF) Plan and TMF for each study
  • Handle the documentation system for company and study documents
  • Assist in employee training and training documentation as needed
  • Ensure company policy and procedure compliance
  • Assist in ensuring GxP compliance with regulatory and Sponsor requirements across all areas
  • Complete vendor qualification and vendor management processes
  • Complete risk assessment process for each vendor
  • Assist in risk assessment process for each study
  • Manage IRB and regulatory requirements for each study
  • Monitor all data privacy policies, including but not limited to HIPAA, GDPR, and CCPA applicable for each study
  • Proactively research, evaluate and make recommendations associated with evolving laws and regulations


Experience
  • Bachelor's degree and/or relevant work experience
  • Strong computer skills including expertise in MS Office (Microsoft Excel, Word, PowerPoint, and Outlook) and internet applications required
  • Ability to work within established timelines, in a fast-paced environment
  • Excellent organizational and priority management skills
  • Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact
  • Great attention to detail and excellent oral and written communication skills
  • Ability to prioritize workload to the changing needs of the day-to-day business
  • Work precisely according to all procedures, rules, and regulations
  • Must maintain strict confidentiality of sensitive data, records, files, conversations, etc.


Emmes is a federal government contractor and requires all employees to be fully vaccinated against COVID-19, to the extent permitted by applicable law. Individuals with medical conditions or sincerely religious beliefs or practices that prevent them from getting the vaccine may request an exemption from the vaccine requirement.

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

  • Unlimited Approved Leave


  • Tuition Reimbursement


  • 401k & Profit Sharing Plan
  • Work From Home Anywhere in the US


  • Maternal/Paternal Leave


  • Casual Dress Code & Work Environment


CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - The Emmes Company, LLC

The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

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