Senior Quality Assurance Associate

Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. 

Job Title: Senior Quality Assurance Associate

Location: Bangalore

Function: Quality & Information Security                   

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Reviewing, approving and analyzing both internal and external compliance related issues and

reports, corrective and preventive actions (CAPA), deviations and notes to file (NTF).

Ensuring all compliance issues are tracked and trended as well as closed in a timely manner.

Performing all functions of both internal and external quality assurance (QA) audits including audit initiation, conducting the audit, issuing an audit report with pertinent observations/findings, and ensuring corrective and preventive actions resulting from the internal audit are appropriately tracked/trended and resolved accordingly.

Tracking and reporting data errors detected during review processes.

Communicating effectively, verbally and in writing, with all internal and external clients.

Escalating quality concerns and problems to the Quality Assurance or designee(s).

Performing QA review of source documents, case report forms (CRFs), offsite shipments and other reports for accuracy as needed.

Designs, develops, implements, and assists in management of all quality assurance programs.

Assisting the Quality Assurance with identifying and implementing process enhancements to

Sitero’s quality systems and processes through appropriate stakeholders.

Conducting external (vendor/supplier) quality audits and hosts Sponsor audits as needed.

Developing applicable Sitero’s training guidelines and SOPs with other stakeholders as needed.

Training peers on all functions of the internal/external audits and compliance reporting programs

as needed.

Management and implementation of ISO, SOC and other certification requirements as required.

Escalating quality concerns and problems relevant stakeholders.

Assisting in identifying and implementing process enhancements to Sitero’s quality systems and

processes through appropriate stakeholders.

Create, maintain, and enforce software development and quality assurance processes that adhere to industry standards and regulations, such as HIPAA and FDA guidelines.

Develop and adhere to IT change management process, SDLC process, validation strategy.

Develop and execute the internal audit strategy for product development division of Sitero. Participate in or facilitate external audits and inspections, assisting in the preparation and response to findings and corrective action plans.

Review and audit software development documentation, including requirements, design specifications, and risk assessments, to identify potential issues and compliance gaps.

Collaborate with teams to identify and mitigate potential risks in healthcare software applications, focusing on patient safety and data security.

Work closely with software developers, testers, and other healthcare professionals to bridge communication gaps and foster a culture of quality throughout the software development lifecycle.

Supporting and management of Quality & Security Incidents across Sitero.

EDUCATION AND EXPERIENCE REQUIRED:

Education:

Bachelor’s degree in science or related field required.

Quality Auditor certification, or equivalent, is preferred.

Experience:

5-7+ years relevant experience in areas of Quality Assurance, Inspection, or Auditing.

Possesses a strong working knowledge of Good Clinical Practices (GCP), Quality/Regulatory Guidelines and is competent with quality control procedures including acceptance criteria.

Computer literate and familiar with most common software applications (i.e., Word, Excel etc.).

Understanding of medical and/or clinical trial terminology is desirable.

Additional skill set:

Ability to work in group setting and independently; ability to adjust to changing priorities.

Excellent attention to detail and orientation toward meticulous work.

Strong interpersonal and communication skills, both verbal and written.

Strong documentation and organizational skills.

Ability to project and maintain a professional and positive attitude.

COMPENSATION & BENEFITS:

Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits.