Quality management specialist job description

ConnectiveRx is a leading, technology-enabled healthcare services company. We work strategically with hundreds of biopharmaceutical manufacturers to help commercialize and maximize the benefits of specialty and branded medications. Our mission is to simplify how patients get on and stay on therapy. We fulfill our mission by providing our customers with innovative services such as patient and provider messaging, the design and operation of copay, vouchers and patient affordability programs, and hub services, all of which accelerate speed-to-therapy and help improve outcomes for manufacturers, healthcare providers and patients.

ConnectiveRx was formed in 2015 by bringing together the industry-leading business of PSKW, PDR/LDM, Careform (2017) and The Macaluso Group (2018) to advance our technology-driven expertise in providing state-of-the-art commercialization solutions. To learn more about our company, visit ConnectiveRx.com
Job Description

Under the guidance of the Senior Director, the Quality Management Documentation Specialist is responsible for strategy, management and primary authorship of company Policies, SOPs, and Work Instructions. The incumbent is responsible for authoring, editing, reviewing, evaluating, maintaining, and controlling documents in a regulated environment.

What you will do:

Works with various subject matter experts within the company to understand the desired workflows and procedures and translate these through effective technical writing into well- written SOPs and work instructions that are clear, unambiguous, and easy to follow. Ensures a consistent tone, style, and format for controlled documents. Assists the organization with Document changes by following and ensuring adherence to the Document Change Management procedures. Acts as Document Management System Administrator. Ensures security of system, availability, and integrity of master documents by implementing document and system access rights and revision controls. Consults with end users to identify problems in accessing electronic content. Troubleshoots issues with the document control software system. Maintains the official document library for the organization. Supports other aspects of the Quality Management System as needed (e.g., internal audits, training, change control, management of deviations & CAPAs, etc.) Establishes and implements policies and procedures regarding document storage, sharing, transmission, and destruction. Evaluates existing document management systems and procedures to determine current effectiveness and efficiency; identifies and recommends improvements. Oversees and manages periodic document reviews on an annual basis; ensures all essential functions for this process are carried out, documented per SOP and completed on time. Oversees document retirement and archiving in accordance with records retention policies and schedules. Educates employees on document control policies and procedures, and partners with leadership to ensure each functional area has necessary written documentation to support their business functions. Maintains current knowledge of best practices, industry standards, client or regulatory standards, document management techniques and technologies related to document management through membership in professional organizations, attending conferences or educational workshops, and professional networking. Performs other duties, as assigned.

What we need from you:

Bachelor's degree in applicable field (e.g., English, Communications, Literature) 2-3 years of relevant experience in a quality management organization as a document control specialist/manager or technical writer. Familiarity with Good Documentation Practices and Quality Systems Document Control best practices. Able to translate complex procedures clearly and efficiently into straightforward written policies and procedures. Able to organize and prioritize work to manage multiple deadlines and business needs. Proficient in Microsoft Word, Visio, PowerPoint, and other standard office software. Demonstrated ability to use time efficiently, transcribe text or audio information accurately, to clearly communicate ideas and concepts. Problem solving, results orientated, analytical and high level of attention to detail.

Travel:

There could be periodic travel up to 15% of the time.

Equal Opportunity Employer:This employer (hereafter the Company) is an equal opportunity employer and does not discriminate in recruitment, hiring, training, promotion, or other employment policies on the basis of age, race, sex, color, religion, national origin, disability, veteran status, genetic information, or any other basis that is prohibited by federal, state, or local law. No question in this application is intended to secure information to be used for such discrimination. In addition, the Company makes reasonable accommodation to the needs of disabled applicants and employees, so long as this does not create an undue hardship on the Company or threaten the health or safety of others at work. This application will be given every consideration, but its receipt does not imply that the applicant will be employed.

At Rady Children's Hospital - San Diego, we strive to deliver outstanding care and service to children and their families. Our newest initiative, Journey To the Top (JTT), is focused on improving patient outcomes throughout our various clinical programs. We are building a team of dedicated individuals who will help support the work of the JTT initiative by providing actionable data to executives, physicians, managers, and other clinicians who care for our patients.

As a Reporting & Analytics Specialist, you will be responsible for the development of an array of visualization tools and dashboards in both Epic and Qlik Sense, maintaining and developing Clarity reports and stored procedures, developing Crystal reports, supporting our data governance process, and helping lead our journey into predictive analytics/machine learning.

Our team strives to provide both growth and learning opportunities for all our team members, pairing each member with a mentor who will help support them throughout their tenure/career at Rady Children's.

Under the direction of the Manager of Data Services this position will be responsible for the analysis, development, modification, general maintenance and validation of Hospital reports, data extracts and data visualizations. The Reporting & Analytics Spec works directly with functional clients, physicians and managers to collect report and/or data extract requirements to include: develop specifications for requested reports, gap analysis, changes to existing reports, identify delivered reports already available, and develops and maintains a self-service searchable index of existing reports or extracts.The Reporting & Analytics Spec provides business application support;training to help interpret data in Epic EMR, advanced structured query language (SQL) techniques, and other common reporting tools; collaborates with functional and technical staff on data architecture issues and changes to Clarity data fields and business processes related to reporting requirements. This position would act as a lead analyst, providing guidance and coaching to other team analysts. This individual would provide direction and insight to new technology and data gathering tools. This position collaborates closely with Information System Programmer Analysts, Managers, and Technical Specialists in functional departments and the Data Governance Committee on proposed changes to data structure and tables required to meet reporting requirements. The Reporting & Analytics Spec develops reports and/or data extracts using advanced tools including: BOE Crystal,

Reporting Workbench, Radar, Excel, Visual design tools such as Qlik. The Reporting & Analytics Spec serves as liaison to Database Administrators and Information Systems staff for large data uploads from internal and external sources. This position is also responsible for overall data quality and develops and executes unit test and validation procedures to ensure delivered information is reliable and accurate.
MINIMUM QUALIFICATIONS:

H.S. Diploma,GED,or Equivalent

3 Years of Experience

PREFERRED QUALIFICATIONS:

Bachelor's Degree

5 Years of Experience

Epic Data Model certification. Prefer more than five (5) certifications.

EOE including disability/vet

8+ years experience

Active TS/SCI and CI polygraph

CompTIA Security+ or similar for IAT Level II DoD 8570 certification

Strong Experience with Microsoft Endpoint Manager and it's management solutions; System Center Configuration Manager (SCCM) and/or Microsoft Endpoint Configuration Manager (MECM)and Windows Server Update Services (WSUS)

Experience and/or familiarity with Microsoft Endpoint Manager cloud-based services, such as Intune, Autopilot and Desktop Analytics

Experience with Microsoft deployment methodology options to include Microsoft Deployment Toolkit (MDT)

Strong Experience with Windows Server 2016, 2019 and 2022

Experience with, and strong understanding of, Windows Active Directory

Experience with, and strong understanding of, Group Policy Configuration and Management

Experience with, and strong understanding of, Windows DNS and DHCP

Valued Skills:

• Experience with Microsoft Windows automation scripting with PowerShell or other scripting languages

• Experience with, and strong understanding of, Windows File and Storage Services, to include Distributed File System (DFS) Namespace and Replication management

• Experience with Microsoft Azure will be valued

• Experience building/managing servers in the AWS (Amazon Web Services) and Azure hosting environment will be valued

• Experience with managing work tasks via tools such as JIRA and ServiceNow

• System configuration based on security guidelines such as DISA STIGs

#JET

Scheduled Weekly Hours:

40

Travel Required:

Less than 10%

Telecommuting Options:

Onsite

Work Location:

USA VA Chantilly

Additional Work Locations:

COVID-19 Vaccination: GDIT does not have a vaccination mandate applicable to all employees. To protect the health and safety of its employees and to comply with customer requirements, however, GDIT may require employees in certain positions to be fully vaccinated against COVID-19. Vaccination requirements will depend on the status of the federal contractor mandate and customer site requirements.We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.