Labs FSP - Laboratory Compliance Coordinator

About the position 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. 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 leverage 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.

Responsibilities

• 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.
• Manage daily service requests for all training related updates in the Learning Management System.
• Escalate training related issues promptly and follow through until resolved.
• Create and maintain training curricula, and training items.
• Create and manage new hire Larning Plans in collaboration with hiring managers.
• Support authoring of Training content.
• Manage training impact assessments for standard operating procedures (SOPs).
• Manage training related documentation and approval workflows in the Electronic Document Management Systems (EDMS).
• Manage scanning, uploading, and indexing of any paper documentation to the EDMS or submission to documentation storage facility.
• Support training compliance requests for laboratory audits and inspections.
• Calculate department training compliance metrics and communicate to management.
• 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.

Requirements

• Degree in scientific or related field with minimum of 5 years experience in GMP environment - either laboratory setting, manufacturing, or quality/compliance.
• 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.
• Local to central NJ area and able to work 50% on site at New Brunswick, NJ and Summit, NJ locations.
• This role will also require communicating with our Moreton, UK site and flexibility for early AM meetings/calls is required.

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!

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