Labs FSP - Laboratory Compliance Coordinator

Work Schedule

First Shift (Days)

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.

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.

Key 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. 

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 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. 

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 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

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 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.