Life Sciences QA Associate Job at Clario, Apply Online

Life Sciences QA Associate Job at Clario, Apply Online

Life Sciences QA Associate Job at Clario, Apply Online. Quality Assurance Associate job at Clario. Life Sciences QA Jobs. Interested and eligible applicants can check out all of the details on the same below

Name of the Post – Quality Assurance Associate

Job ID – R10253

Location – Mysore, India_DSS

Primary Responsibilities

Supports quality processes to promote, facilitate and ensure compliance with all regulatory and company standards by –

• Supports efforts across cross-functional teams to advance both internal and external compliance related issues (quality events, CAPAS, audit findings) and reports according to established timelines.
• Support the tracking and trending of all compliance reports and audit activities.
• Facilitating both internal and external quality assurance (QA) audits including audit preparation activities as well as follow-up to pertinent observations/findings, and ensuring corrective and preventive actions resulting from the internal audit are appropriately tracked/trended and resolved accordingly
• Communicating effectively, verbally and in writing, with all internal and external clients
• Escalating quality concerns and problems to the Manager, Quality and Regulatory Compliance or designee(s)
• Performing QA review of source documents, case report forms (CRFs), offsite shipments and other reports for accuracy as needed
• Working directly with Bioclinica development teams to ensure the accuracy and consistency of system development and validation deliverables.

Assists in the management of all quality assurance programs by:

• Assisting Quality and Regulatory Compliance personnel with identifying and implementing process enhancements to Bioclinica’s quality systems and processes through appropriate stakeholders
• Supporting external (vendor/supplier) quality audits and hosting Sponsor audits as needed
• Participating in teams to provide applicable Bioclinica Quality Management Systems (QMS) guidelines and support with other stakeholders as needed
• Facilitate quality training of peers on quality-related matters as needed

Secondary Responsibilities

Maintains Quality Service and Departmental Standards by

• Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”)
• Assisting in establishing and enforcing departmental standards

Contributes to team effort by

• Working with internal staff to resolve issues
• Exploring new opportunities to add value to organization and departmental processes
• Helping others to achieve results
• Performing other duties as assigned

Maintains Technical and Industry Knowledge by

• Attending and participating in applicable company-sponsored training

Qualifications–

Education 

• Associate’s degree or equivalent required, preferably in life sciences and/or computer science

Experience –

• 0-1 year of relevant experience or equivalent education in areas of Quality Assurance, Auditing, Validation, and/or SDLC systems in regulated industries-preferably in Pharmaceutical, Biotech, Medical device
• Possesses strong working knowledge of Good Clinical Practices (GCP), ICH Guidelines, and Software Validation requirements and is competent with quality management systems (QMS)
• Knowledgeable of 21 CFR Part 11, Annex 11, and other applicable ERES regulations
• Computer literate and familiar with most common business software applications
• Understanding medical and/or clinical trial terminology is desirable

Additional skillset –

• Ability to work independently and/or across cross-functional teams; 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 manage multiple tasks effectively & efficiently
• Proficient at problem-solving
• Goal-oriented
• Ability to project and maintain a professional and positive attitude
• Possess high-level ethics and integrity

Working conditions

• Travel – 0-15%
• Lifting – 0-20 lbs
• Other – Computer work for long periods of time

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