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QA Coordinator
4 months ago
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Department: Global Quality & Compliance Location: Middleton, WI Notes: Full-time, Benefits, Annual Bonus, 401k Match, PTO
Discover Impactful Work:
Provides support to and coordination of activities for departmental functional area(s). Prepares and maintains various records, trackers and files related to GQC activities. Conducts follow-up on processes, documents, and status as required. Observes and assists with assigned GQC tasks which may be limited to a few processes or functional areas.
A day in the Life:
Schedules client audits for the Middleton and Athlone GMP laboratories. Ensures Confidentiality Disclosure Agreements (CDA’s) are in place prior to all third-party audits. Creates audit folders and stages folders with procedures, policies and frequently requested audit documents. Provides in-person day-of support for client audits including room set-up and logistics. Provides coordination and administrative support to management and professional staff on processes or functional areas which may include setting up meets, taking minutes, and other tasks. Maintains files, runs reports, and tracks activities for the group. Observes and assists with assigned core activities, as directed. Performs functional area support for processes or functional areas.
Keys to Success:
Education
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Experience
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years) or equivalent combination of education, training, and experience.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, Abilities
Familiarity with GxP and appropriate regional clinical research regulations and guidelines Ability to effectively work in an unpredictable environment with flexibility around scope of job/customer needs Strong attention to detail and accuracy Ability to prioritize, multi-task responsibilities and monitor quality of own work Ability to recognize when issues require escalation to management Ability to work to high standards of ethics Ability to deal effectively with pressure Ability to proactive and committed to developing personal skills, knowledge and behaviors Good communication skills, organizational skills and ability to work well with others Computer Skills: Microsoft Word, Excel and PowerPoint and Internet applications Good English language skills
Work Environment
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary and/or standing for typical working hours. Able to lift and move objects up to 25 pounds. Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
