Quality Management Systems Associate (Remotely based anywhere in the US) Job at RTI International

RTI International Remote

Overview:
RTI-Health Solutions (RTI-HS) provides scientifically rigorous research and consulting services to pharmaceutical, biotechnology, medical device and diagnostics companies. Our research and consulting services focus on gathering evidence, analyzing results, increasing understanding, and providing greater clarity to help reveal the benefits, risks, value, and potential of our client’s products. Our various practice areas include: Market Access and Outcomes Strategy, Patient-Centered Outcomes Assessment, Health Economics, Pharmacoepidemiology and Risk Management, Biostatistics, Surveys and Observational Studies, and Health Preference Assessment.

We are currently looking to add a Quality Management Systems Associate to support the electronic Quality Management System (QMS). In this role you will be responsible for maintaining documents and records in the system as configured to meet regulatory, quality and client requirements and for facilitating document workflows to support quality activities of the organization.

You will manage day-today administration of the eQMS, maintain computerized files to support the lifecycle of all documents in the quality management system, write job aids and work instructions. Additionally, you will perform record management duties, compile, and maintain computerized files, and update logs, databases and catalogues of record retention information.
Responsibilities:
Additional responsibilities will include but not be limited to:

  • Collaborate with stakeholders to manage document repositories and monitor quality management system workflows (Documents, Training, Change Control, Deviations, Quality Events, CAPA, Audits)
  • Conduct system user training, support and trouble shooting
  • Test eQMS changes to support business needs and continuous improvement.
  • Update QMS and catalogues of quality management and compliance information.
  • Provide guidance on controlled document standards.
  • Prepare process and status reports.

To be successful in this role, you will demonstrate core competencies which include:
  • Interpersonal Relationships
  • Planning and Organizing
  • Technical Excellence
  • Effective Communications
  • Quality Management Software
  • Working with Microsoft Office
  • Project Management
Qualifications:
  • Bachelor's Degree and 2 years of experience, or equivalent combination of education and experience, with 6 years of directly related experience being equivalent to a Bachelor's level degree.
  • Strong Attention to detail and high degree of accuracy.
  • Proficiency in MS Office (Word, Outlook, PowerPoint, Excel).
  • Basic understanding of Good Clinical/ Manufacturing/ Laboratory Practices (GxP).
  • Collaborates well with others.
  • Self-directed and able to work independently.
  • Communicates effectively both verbally and in writing.
  • Ability to focus on timelines and quality.
  • Ability to manage multiple tasks.
EEO & Pay Equity Statements:

As a global employer of choice, RTI is committed to equity, diversity, inclusion and belonging in the workplace and the communities and markets where we serve our mission. We value diversity of thought, culture, background and perspective and welcome applicants without regard to race, color, religion, sex, age, marital status, sexual orientation, gender identity, national origin, creed, citizenship status, disability, protected veteran status, or any other classification protected by applicable discrimination laws or RTI policy.

We are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. Further information is available here.

RTI International is an independent, nonprofit research institute dedicated to improving the human condition. Clients rely on us to answer questions that demand an objective and multidisciplinary approach and one that integrates expertise across the social and laboratory sciences, engineering, and international development. We believe in the promise of science, and we are inspired every day to deliver on that promise for the good of people, communities, and businesses around the world. For more information, visit www.rti.org.

For USA Job Postings Only: RTI participates in the US Government E-Verify program. Further information regarding the E-Verify program and laws that are designed to protect you against discrimination relating to your legal right to work in the US can be found here.

For San Francisco, CA USA Job Postings Only: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Further information is available here.


The anticipated pay range for this role is listed below. Our pay ranges represent national averages and may vary by location as a geographic differential may be applied to some locations within the United States.


RTI considers multiple factors when making an offer including, for example: established salary range, internal budget, business needs, and education and years of work experience possessed by the applicant. Further, salary is merely one element to our offer.


At RTI, we demonstrate our commitment to rewarding individual and team achievement through a total rewards package. This package includes (among other things) a competitive base salary, a generous paid time off policy, merit based annual increases, bonus opportunities and a robust recognition program. Other benefits include a competitive range of insurance plans (including health, dental, life, and short-term and long-term disability), access to a retirement savings program such as a 401(k) plan, paid parental leave for all parents, financial assistance with adoption expenses or infertility treatments, financial reimbursement for education and developmental opportunities, an employee assistance program, and numerous other offerings to support a healthy work-life balance.




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