Senior Lab Compliance Coordinator at Thermo Fisher Scientific

Posted in Other about 9 hours ago.

Location: New Brunswick, New Jersey





Job Description:

Work Schedule

Standard (Mon-Fri)



Environmental Conditions

Office



Job Description



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.


Location/Division Specific Information


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 clients to make the world healthier, safer, and cleaner.


Within our Analytical Services team, we have a functional service provider solution, which is an outstanding partnership that allows our customers to use 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.


This position can be located in either New Brunswick, NJ or Summit, NJ and may require travel between sites. The role is 50% or more onsite with remote opportunities. This role will also require communicating with the Moreton, UK site - requiring flexibility for early AM meetings/calls.


A Day In the Life


  • Support all aspects of the Training Management program for GMP laboratories and supporting functions that support clinical manufacturing.


  • Responsible for ensuring compliance with company requirements for GMP Training Management.


  • Perform Administrator duties in the Learning Management System.


  • Create and maintain training curricula.


  • Support authoring of Training content.


  • Perform training impact assessments for standard operating procedures (SOPs).


  • Manage training related documentation in the Electronic Document Management Systems (EDMS).


  • Propose and obtain endorsement to changes (creation, modification, obsoletion) to training with stakeholders.


  • Supporting compliance requests for laboratory audits and inspections.


  • Harmonization of training practices between sites and groups - Schedule cross functional team meetings, collect feedback, create proposals, post on SharePoint, schedule reviews, collect and resolve feedback.


  • Prepare SOP periodic review timetable and ensure the review/approval or retirement are completed in support of the procedure lifecycle in timely manner.


  • Work independently but recognize need to consult stakeholders and keep them informed of progress.


  • A self-starter with an ability to manage electronic systems, MS outlook and office with minimal training and supervision.


Education and Experience:


  • Bachelor's degree or equivalent and relevant formal academic / vocational qualification


  • AND 5+ years of previous experience that provides the knowledge, skills, and abilities to perform the job or equivalent combination of education, training, & 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 and Abilities:


  • Experience in training management is a must and writing and reviewing standard operating procedures is a plus.


  • Demonstrated ability to successfully manage competing deadlines and balance priorities.


  • Excellent technical writing skills, close attention to detail and excellent follow up.


  • Proficient in Microsoft outlook, word, excel, MS team meetings, SharePoint, Learning Management Systems (LMS), Electronic Document Management Systems (EDMS). Able to conduct video conference calls via MS teams 4-6 hours a day with team members at different sites.


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.


Benefits:


We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!


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.


Apply today! http://jobs.thermofisher.com
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