Laboratory GMP Compliance Coordinator

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Laboratory Setting

Job Description

ONSITE:

This is a fully onsite role based at our customer’s site in New Brunswick, NJ. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.

Must be legally authorized to work in the United States without sponsorship.

Must be able to pass a comprehensive background check, which includes a drug screening.

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.

Our Laboratories Functional Service Partnership (FSP) team plays a direct role in advancing drug development by creating sustained groups of talent within our customers’ organizations to provide long-term support. Through this collaborative approach, our professionals bring their commitment to excellence, industry knowledge, and operational strength directly into customer environments, helping to enhance capabilities and advance the delivery of life-changing therapies.

Key responsibilities:

• Support all aspects of the Documentation and Training Management program for GMP laboratories and supporting functions that support clinical manufacturing.
• Responsible for ensuring compliance with company requirements for GMP Documentation and 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 Learning Plans in collaboration with hiring managers.
• Support authoring of Documentation and 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 documentation and 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: ·

Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’) ·

Experience working in GMP environment- either laboratory setting, manufacturing, or quality/compliance.

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 GMP training management and/or GMP documentation is preferred
• Writing and reviewing standard operating procedures, experience with change control and deviations/investigation 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. (flexibility for early AM meetings/calls due to time zones)

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.

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