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Quality Management Systems Specialist

Imaging EndpointsHyderabad, Republic Of India, IN

10 days ago

Job description

Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM . Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial’s imaging to optimize the opportunity to demonstrate efficacy.

Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts;
London, UK;
Leiden, Netherlands;
Basel, Switzerland;

Hyderabad, India and Shanghai, China. We are an affiliate of HonorHealth, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL / RadPartners), the largest private radiology group in the United States. We are recognized as the world’s largest and most preeminent iCRO in oncology.

The primary responsibility of the IT QA Specialist is to assist in the management of areas of Quality Assurance (QA) and Information Technology (IT) related to Imaging Endpoints (IE) Core Lab Quality Management System (QMS). The IT QA Specialist positions will be solutions-oriented, facilitate timely quality decisions, and meet the needs of the business and all stakeholders with respect to quality assurance principles and practices.

IT QA SPECIALIST

RESPONSIBILITIES

Provide quality system management within the regulations of investigational products and quality standards, specifically, 21 CFR Part 312, 21 CFR Part 211, 21 CFR Part 11, and ISO 13485.

Provide direct QA support related to the IE QMS and Innovation and IT infrastructure.

Develop, revise, implement, maintain the company’s Installation Qualifications (IQs), Operational Qualifications (OQs) and Performance Qualifications (PQs) to ensure system hardware and software validations follow all relevant regulations.

Develop and implement validation / qualification protocols for clinical imaging data management tools and electronic systems.

Responsible for the quality of documentation approved to support GxP activities for Imaging Endpoints and sponsor-related projects.

Provide responses for Request for Information (RFI) questionnaire.

Establish and implement QA procedures and controls to develop a compliant Core Lab QMS and Innovation and IT infrastructure.

Review and approval of GxP documentation to ensure that guidelines are met.

Interface with the Compliance and Regulatory Affairs department to implement quality system strategies and plans to facilitate continuous improvement of the regulated electronic systems.

Aid in the generation of responses to inspectional findings and audits, as applicable.

Interface with other areas of the organization to provide sound QA decision-making in areas that impact the Innovation and IT infrastructure and electronic systems.

Interact with third parties in matters pertaining to information technology, regulatory, quality and compliance issues.

Electronic document management experience in a regulated environment preferred.

Facilitate good conduct of inspections and audits by communicating effectively, preparing documentation, training staff, and providing accurate information.

Perform other duties as assigned by departmental management.

EDUCATION AND EXPERIENCE

Bachelor’s degree in information technology, Computer Science, or related fields.

Five (3) years of experience in regulated industries with at least two (2) years in pharmaceuticals or medical devices.

Imaging Core Lab experience desired.

Familiarity with medical imaging applications and DICOM network is preferred.

Knowledge of Windows server and VMWare, Citrix, Active Directory, LAN, and desktop operating systems (Windows 10, macOS) preferred.

Electronic document management experience in a regulated environment preferred.

Maintain Knowledge of 21 CFR Part 11, 21 CFR Part 312, ISO 13485 and FDA current thinking and interpretation of regulations and guidelines.

Comprehension of Validation practices (e.G., GAMP 5), and experience in reviewing and approving hardware and software validation reports.

Knowledge of Good Manufacturing Practices regulations.

Experience in preparation and / or review of documents submitted to FDA for review.

QMS experience is preferred.

Quality risk management experience preferred.

Proficiency in Microsoft Office and internet applications required.

SKILLS

Excellent hands-on computer skills with thorough knowledge of Microsoft Office, including Excel and PowerPoint (statistics, graphing, presentations, etc.).

Ability to adapt to changes in the work environment, manage competing demands, change approaches or methods to fit the situation best, and deal with change, delay, or unexpected events.

Proficiency in Microsoft Office and internet applications required.

Knowledge of Windows server as well as with VMWare, Citrix, Active Directory, and desktop operating systems (Windows 10 and Mac) is a plus.

Knowledge of 21 CFR Part 11 and ISO 9001.

Knowledge of Risk-based validation practices and Software Life Cycle (SDLC) management.

Knowledge of Microsoft Office 365 preferred.

Knowledge of Citrix preferred.

Service-oriented approach, flexible, and proactive. Work precisely and in compliance with all procedures, rules, and regulations.

Must maintain strict confidentiality of sensitive data, records, files, conversations, etc.

Must have superior attention to detail.

Ability to excel in a team environment.

Ability to multitask and work under pressure.

Strong organization and planning skills.

Ability to understand technical concepts and communicate them to business users.

Excellent interpersonal, organizational, and communication skills, including oral and written.

Self-motivated and able to grasp new concepts and learn quickly and motivate others.

Ability to manage projects and deliverables with high accuracy and completeness.

Self-driven, ability to get the job done with little supervision, positive can-do attitude.

IMAGING ENDPOINTS’ TEAM CHARACTERISTICS

Passion to Connect Imaging to the CureTM and pursue a meaningful career by improving the lives of cancer patients through imaging

Strong desire to be part of a dynamic, global team working closely together and growing year after year in a rewarding environment to help humanity through imaging

Commitment and caring for our fellow team members, their families, and the communities IE serves - see Caring Endpoints https : / / caringendpoints.Org /

Integrity and high ethical standards;

we always do the right thing

High intellect and ingenuity;

we enjoy solving problems, finding a better way, and the challenge of making a difference by improving lives

Structured, organized, detail-oriented, and self-motivated;

we approach each day with a detailed plan and excitement to accomplish the day’s objectives while striving to improve ourselves and IE everyday

Accountable;

we do what we say and communicative effectively to meet deadlines;

we enjoy advancing clinical trials, helping patients, and celebrating success

High standard for excellence;

we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else

PHYSICAL REQUIREMENTS

While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel;

reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.

Travel : About 5 - 10% (domestic or international)

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Quality Specialist • Hyderabad, Republic Of India, IN

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