Quality Assurance Manager

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Home-Based Quality Assurance Manager

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

The QA Manager oversees one or several components of the quality program at Emmes and assists in managing the Quality Assurance (QA) Department. The QA Manager works with department, company, and project leadership to ensure adherence to applicable regulations, industry standards, and project requirements.

Responsibilities
  • Manages several components of Emmes' Quality Management System
  • Drafts QA policies, procedures, and processes
  • Interprets and implements quality standards
  • Collects quality data for improvement in the quality system
  • Prepares Quality Management Reports for internal leaders
  • Verifies compliance of internal processes to applicable Standard Operating Procedures (SOPs) and regulations by performing internal audits
  • Reviews and approve corporate SOPs, as needed
  • Reviews documentation under QA purview for accuracy and compliance (Compliance/Variance Tables, training records, test plans/scripts, CAPAs, audit reports, etc.)
  • Supports external and regulatory audits / inspections
  • Provides corporate quality process training as needed
  • Supervises staff
  • Other duties as assigned

Experience
  • Bachelor's degree in Life Sciences or a related scientific field or commensurate experience in quality assurance in a regulated environment
  • CQA, CCRP, ISO certification (or applicable equivalent) preferred
  • 7 years' experience working in an FDA-regulated environment
  • Ability to prioritize critical tasks and provide a high level of responsiveness and timely service on a day to day basis, as well as balancing the unexpected needs of the company as they arise
  • Demonstrated organizational skills, high attention to detail, and ability to multi-task
  • Strong written, verbal, and problem-solving skills
  • MS Office proficiency
  • Minimun Travel Required


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!

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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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