Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to demonstrate the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.Lab Data Associate II:Below are the services PPD are to perform (not an all-inclusive list and applicable to each FSP FTE asappropriate to the FSP FTE job function):Uploading internal documents and/or 3rd party data into electronic document management system (such as Veeva QualityDocs)Formatting documents per relevant SOP and/or job aid Circulating documents for approval, and follow through to ensure timely approvalAssist the Manager with tracking and following up with the implementation of control procedures, job aids and other documentation necessary for the client to operate, CAPAs, risks registers etcAssesses procedures for accuracy, simplicity, and practicality and influences changes as appropriateAssists/participates in preparation for and support of regulatory agency inspections, corporate and customer audits.Builds and maintains good working relationships with internal and external partnersPerforms data verification as necessaryManages issues and risks identified in area of responsibility Education and Experience:High / Secondary school diploma or equivalent and relevant formal academic / vocational qualificationTechnical positions may require a certificatePrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 6 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. 
 
Knowledge, Skills and Abilities:Ability to focus on details.Critical thinking skills to identify and solve problems.Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company and external partner sites.Strong organizational skills in order to maintain a high level of productivity and setting priorities in order to complete assignments in a timely manner.Exhibits high initiative, strong drive and follow-through.At least 1 year of GMP experience is strongly preferredKnowledge of and ability to use electronic Learning Management system (such as MyLearning), electronic document management systems (Veeva)Knowledge of GMP, Good Documentation Practices and pharmaceutical manufacturingAbility to manage databases of document owners, reviewers, approvers, authors and trending dataAbility to coordinate documentation projects involving multiple documents and external partnersAbility to influence, motivate and gain commitment without direct authorityWorks well with peers and all levels of managementDisplays strong leadership, facilitation, teamwork, networking, presentation, and planning skillsExcellent verbal and written communication and interpersonal skillsExhibits high initiative, strong drive and follow-through.Effective organizational skillsGood computer skillsStrong attention to detail and problem solving skillsGood written and verbal communication skillsAbility to effectively conduct oral presentationsDemonstrated experience in identification and resolution of technical problems in a professional environmentAbility to attain, maintain and apply a working knowledge of applicable procedural documentsDemonstrated positive attitude, enthusiasm toward work, and the ability to work well with others