Labs FSP - Laboratory Compliance Coordinator at Thermo Fisher Scientific

New Brunswick, New Jersey, United States

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Not SpecifiedCompensation

Junior (1 to 2 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Biotechnology, Clinical ResearchIndustries

Requirements

Degree in scientific or related field with minimum of 5 years experience in GMP environment (laboratory setting, manufacturing, or quality/compliance)
Experience in training management (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 Teams 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
Flexibility for early AM meetings/calls (communicating with Moreton, UK site)
In some cases, equivalency of appropriate education, training, and/or directly related experience considered

Responsibilities

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

Skills

Key technologies and capabilities for this role

GMP ComplianceTraining ManagementLearning Management SystemLaboratory ComplianceGMP Training

Questions & Answers

Common questions about this position

What education and experience are required for this role?

A degree in a scientific or related field is required along with a minimum of 5 years of experience in a GMP environment, such as laboratory setting, manufacturing, or quality/compliance.

What are the key responsibilities of the Laboratory Compliance Coordinator?

Key responsibilities include supporting the Training Management program for GMP laboratories, managing service requests in the Learning Management System, creating training curricula, managing documentation in EDMS, and calculating training compliance metrics.

Is this a remote position or does it require onsite work?

This information is not specified in the job description.

What is the salary or compensation for this position?

This information is not specified in the job description.

What skills make a strong candidate for this role?

Strong candidates are self-starters able to work independently, manage electronic systems like Learning Management System and EDMS, MS Outlook and Office with minimal training, and recognize when to consult stakeholders.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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