Internal Quality Auditor (Madison, WI)
Forte/Advarra is the industry-leading provider of software and services in the critical areas of clinical trial management, clinical data management and research administration for cancer centers, academic medical centers and health systems.
Essential Job Duties (in order of priority)
- Evaluate production processes for compliance with quality requirements.
- Work with all Forte/Advarra team members to collect Quality Management System (QMS) input, update existing process, work instruction and guidance documentation.
- Develop new tools to support QMS implementation (new guidance docs, flowcharts, etc.)
- Update and create customer facing documentation related to Forte/Advarra compliance and regulatory affairs.
- Manage new team member and existing team member update QMS training activities and records.
- Assist with annual QMS monitoring activities.
- Participate in and assist with coordination of external QMS audits.
- Maintain and administer annual HIPAA certification testing.
- Work with software development lifecycle (SDLC) teams to monitor product release activities.
- Escalate any concerns or risks related to the release or the SDLC processes being followed to the Product Manager and/or SDLC team leadership.
- Work with product SDLC teams to confirm all release readiness activities are complete prior to releasing product to customers.
- Ensure all post release activities are complete prior to final closeout of a project.
- Participate in weekly product release status meetings
Job Qualifications & Job Evaluation
Documentation: The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Bachelor’s degree required; or equivalent work experience
- 4+ years of previous experience in an FDA regulated or ISO-9001/ISO 27001 environment.
- Previous experience with a software company and software development lifecycle processes.
- Prior project management experience a plus.
Knowledge, Skills & Abilities
- Ability to provide and elicit appropriate feedback to and from team members.
- Innate curiosity about processes and systems.
- Demonstrated ability to analyze problems and understand the necessary components of a solution through analysis, planning, and evaluation of cost/benefit.
- Excellent communication skills, including listening, writing, and speaking. Must demonstrate the ability to confer detailed process and workflow instructions.
- Effective technical writing skills including previous experience in writing procedures or processes.
- Ability to assess the stakeholders understanding of process and the desired outcome.
- Demonstrated ability to effectively negotiate and build consensus with various audiences, plan and manage project activities while facilitating and developing business strategy through internal and external relationships.
- Willingness to embrace and drive change.
- Demonstrated accountability in project ownership and solution-oriented work approach.
- Proficient in the use of Microsoft Word, Excel, Visio and PowerPoint. Proficient in email
Licenses & Certifications
- None required
- Ability to lift 25 pounds
Forte/Advarra Research Systems is an equal opportunity employer and does not discriminate on any basis prohibited by federal, state or local law.