Labs FSP Laboratory Compliance Coordinator

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll 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 Fishers 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.

Key responsibilities:

• Support all aspects of the Training Management program for GMP laboratories andsupporting 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 ElectronicDocument Management Systems (EDMS).
• Manage scanning uploading and indexing of any paper documentation to the EDMS orsubmission 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 theminformed of progress.
• A self-starter with an ability to manage electronic systems MS outlook and office withminimal training and supervision.

Education and Experience:

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 operatingprocedures 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 LearningManagement Systems (LMS) Electronic Document Management Systems (EDMS). Able toconduct video conference calls via MS teams 4-6 hours a day with team members at differentsites.

Local to central NJ area and able to work 50% on site at New Brunswick NJ and Summit NJlocations. This role will also require communicating with our Moreton UK site and flexibility forearly AM meetings/calls is required.

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.

Working Environment:

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 100000 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!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example this may include individuals requiring assistance because of hearing vision mobility or cognitive impairments. If you are a job seeker with a disability or assisting a person with a disability and require accessibility assistance or an accommodation to apply for one of our jobs please submit a request by telephone at 1-*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

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