GCP Quality Assurance Auditor
Overview
RTI Health Solutions (RTI-HS), a business unit of RTI International, is an independent and internationally recognized research organization. We provide healthcare consulting and research expertise to optimize decision-making for pharmaceutical, biotechnology, and medical device products across the development and marketing life cycle.Clients rely on our expertise, quality standards, and integrity to guide their product development and regulatory and market access strategies. Our service groupings include Value, Access, and HEOR; Patient-Centered and Outcomes Research; Epidemiology and Biostatistics; Medical Communications; Global Business Operations; and Strategic Consulting and Growth.
RTI-HS has office locations in the US, UK, Spain, France, and Sweden. We are currently seeking a Quality Assurance Auditor to provide oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.
In this role, you will Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance. You will work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines.Additionally, you will lead audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
Responsibilities- Ensures the quality assurance programs and policies are maintained and modified regularly.
- Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
- Conducts internal audits.
- Provides project support as needed and reviews project-related documents.
- Tracks and manages internal and external corrective and preventive actions.
- Maintains audit-related documents.
- Recognizes the need for, organizes, and conducts training programs.
- Keeps current on regulations and guidance.
- Evaluates compliance with all of RTI, all applicable regulations, project policies and procedures.
- Reviews and writes standard operating procedures and QA policies, procedures, and related documents.
- Writes audit plans and audit reports.
- Conducts audits and inspections of GCP and non-regulated documentation.
- Tracks and reviews proposals.
- Reviews and audits validated systems.
To be successful in this role, you will demonstrate the following attributes:
- Ability to prioritize multiple tasks.
- Ability to work well with others.
- Ability to listen and communicate well both verbally and in writing.
- Ability to work independently and as part of a team.
- Attention to detail and accuracy.
- Bachelor's Degree and 5 years of related experience
- Experience with GCP audits and regulatory inspections.
- Excellent knowledge of MS Word, Outlook, Power Point, Excel.
Preferred:
- Quality Auditor Certification desirable.
- Non-interventional/observations research experience.
#LI-BM1
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.
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.
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.
Equal Pay Act Minimum/Range
$80,000.00-$100,000.00
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.
Click here. to view the EEOC Know Your Rights Poster.