Quality Assurance Specialist -Remote
- Employer
- The Emmes Company, LLC
- Location
- Remote
- Salary
- Competitive
- Posted
- Feb 08, 2023
- Closes
- Feb 09, 2023
- Ref
- 3717
- Function
- Other
- Industry
- Science
- Career Level
- Experienced (Non-Manager)
- Hours
- Full Time
Quality Assurance Specialist - GCP
Rockville, MD & Remote
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 Quality Assurance (QA) Specialist assists the QA Department in maintaining the quality system via conducting internal and vendor audits, supporting client audits and regulatory inspections, and drafting Standard Operating Procedures (SOPs) as needed. The QA Specialist assists QA management in guiding the direction of the Quality Management System. This individual works with project and department leaders to assist projects and departments with adherence to applicable regulations, industry standards, and project requirements.
Responsibilities
• Conducts internal audits of projects, processes, and departments
• Reviews documentation for accuracy and compliance (e.g., training records, test
plans/scripts, CAPAs, audit reports, etc.)
• Assists in verifying compliance to applicable Standard Operating Procedures (SOPs) and
regulations by performing internal audits
• Supports or leads supplier/vendor qualification and evaluation
• Supports or leads client audits and regulatory inspections
• Leads process improvement projects
• Writes and reviews corporate SOPs and policies
• Conducts trainings as needed
• Other duties as assigned
Experience
• Bachelor's degree in Life Sciences or a related scientific field or equivalent experience
• CQA and/or RAC certification preferred
• 2 + years of e xperience working in an FDA-regulated environment utilizing GCP auditing activities required
• Ability to prioritize critical tasks and provide a high level of responsiveness and timely service
on a day-to-day basis as well as balance the unexpected needs of the company as they arise
• Demonstrated organizational skills, high attention to detail, and ability to multi-task
• Strong written and verbal communication as well as problem-solving skills
• Microsoft Office proficiency
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:
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.
Rockville, MD & Remote
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 Quality Assurance (QA) Specialist assists the QA Department in maintaining the quality system via conducting internal and vendor audits, supporting client audits and regulatory inspections, and drafting Standard Operating Procedures (SOPs) as needed. The QA Specialist assists QA management in guiding the direction of the Quality Management System. This individual works with project and department leaders to assist projects and departments with adherence to applicable regulations, industry standards, and project requirements.
Responsibilities
• Conducts internal audits of projects, processes, and departments
• Reviews documentation for accuracy and compliance (e.g., training records, test
plans/scripts, CAPAs, audit reports, etc.)
• Assists in verifying compliance to applicable Standard Operating Procedures (SOPs) and
regulations by performing internal audits
• Supports or leads supplier/vendor qualification and evaluation
• Supports or leads client audits and regulatory inspections
• Leads process improvement projects
• Writes and reviews corporate SOPs and policies
• Conducts trainings as needed
• Other duties as assigned
Experience
• Bachelor's degree in Life Sciences or a related scientific field or equivalent experience
• CQA and/or RAC certification preferred
• 2 + years of e xperience working in an FDA-regulated environment utilizing GCP auditing activities required
• Ability to prioritize critical tasks and provide a high level of responsiveness and timely service
on a day-to-day basis as well as balance the unexpected needs of the company as they arise
• Demonstrated organizational skills, high attention to detail, and ability to multi-task
• Strong written and verbal communication as well as problem-solving skills
• Microsoft Office proficiency
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.