Clinical Quality Assurance Specialist II

at  Thermo Fisher Scientific

JOB DESCRIPTION

When you are part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
Fisher Clinical Services, part of Thermo Fisher Scientific, is a leading provider of global clinical supply chain. With unwavering commitment to service, science and process engineering, Fisher Clinical Services is powered by people with an exceptional commitment to quality, deeply instilled ethics of personal responsibility and unrivalled expertise. We are exclusively focused on serving the packaging and distribution requirements of clinical trials across the world. Whether planning, packaging, labelling, storing, or distributing the important supplies needed to perform clinical research, for more than 27 years Fisher Clinical Services has been committed to delivering the highest possible value while ensuring adherence to the highest level of quality, performance, reliability and sustainability standards. http://www.fisherclinicalservices.com

SUMMARIZED PURPOSE:

Conducts internal computer system validation deliverable reviews to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations. Identifies issues impacting quality and/or regulatory compliance, determines root cause of non-conformance and develops strategies to address issues. May perform technical document review and other GxP activities in support of ISQA project work or company process.

ESSENTIAL FUNCTIONS AND OTHER JOB INFORMATION:

Job Description

Responsibilities will include the reviewing and approving of Computer System Validation documentation to succeed in the:

• Facilitation of closure of the more than 500 gaps identified due to the EMA Guideline on computerized systems and electronic data in clinical trials
• Reviewing and approving End User Tool documentation (Power BI dashboards, spreadsheets, reports, etc.)
• Reviewing and approving Audit Trail Review Plans and supporting documentation
• Supporting additional computer system validation initiatives within the ISQA Computer Validation Compliance team, as required

Knowledge, Skills and Abilities:
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

• Thorough knowledge of applicable GxP regulations, including 21 CFR Part 11, EMA , ICH and appropriate regional regulations
• Strong computer skills; ability to learn and become proficient with appropriate software
• Firm knowledge of Power BI/apps experience
• Good knowledge of SOPs and WPDs
• Excellent oral and written communication skills (including appropriate use of medical and scientific terminology)
• Strong attention to detail
• Effectively works independently or in a team environment
• Effective problem solving skills
• Solid organizational and time management skills including ability to multitask and prioritize competing demands/work load
• Proven flexibility and adaptability