Lead Ops Training Coordinator (Nights) at Thermo Fisher Scientific

Greenville, North Carolina, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Manufacturing, Life SciencesIndustries

Requirements

Bachelor's degree in a relevant subject area is preferred. High school diploma/GED is minimally required
Minimum of 2 years of experience in pharmaceutical operations, preferably on an isolator line
At least 1 year in a training or supervisory role. Other roles and responsibilities in a training or educational capacity will be considered
In-depth knowledge of GMP, FDA regulations, and aseptic processing standards
Excellent communication, presentation, and interpersonal skills
Strong organizational and project management abilities
Proficiency in MS Office and training software
Preferred: Experience with Lean Six Sigma or other continuous improvement methodologies
Preferred: Familiarity with e-learning platforms and digital training tools
Ability to work third shift (nights, typically 6pm-3am, Monday through Friday, with some weekend work possible) in cleanroom and production floor environments (no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc.)

Responsibilities

Design, develop, and update comprehensive training programs for Steriles South operations
Create training materials, manuals, and SOPs in collaboration with subject matter experts
Ensure training programs meet regulatory requirements and company standards
Conduct training sessions for new hires and ongoing training for existing employees
Coordinate with external trainers and consultants as needed
Ensure all training activities are documented and records are maintained accurately
Update training records and certifications as required
Lead and mentor the Steriles South operations team
Identify skill gaps and provide targeted training to address them
Foster a positive learning environment that encourages professional growth and development
Assess training effectiveness through feedback and performance metrics
Implement improvements to training programs based on evaluation results
Stay current with industry trends, regulatory changes, and best practices in sterile filling operations
Work closely with operations, quality assurance, and human resources departments to align training with organizational goals
Participate in cross-functional projects to enhance Steriles South operations and overall efficiency

Skills

Key technologies and capabilities for this role

Training Program DevelopmentSOP CreationRegulatory ComplianceTeam LeadershipMentoringPerformance MetricsContinuous ImprovementQuality AssuranceSterile Filling OperationsDocumentation Management

Questions & Answers

Common questions about this position

What are the typical working hours for this role?

Typical working hours are 6pm-3am, Monday through Friday, with some weekend work possible. This is a third shift (nights) position.

What qualifications and experience are required for this position?

A Bachelor's degree in a relevant subject is preferred, with a minimum high school diploma/GED required. Candidates need at least 2 years of experience in pharmaceutical operations (preferably on an isolator line), 1 year in a training or supervisory role, in-depth knowledge of GMP, FDA regulations, and aseptic processing standards, plus excellent communication, organizational, and MS Office proficiency.

What is the salary or compensation for this role?

This information is not specified in the job description.

What does the company culture emphasize in this role?

The role fosters a culture of continuous improvement and operational excellence, with a focus on creating a positive learning environment that encourages professional growth and development.

What makes a strong candidate for this Lead Ops Training Coordinator position?

Strong candidates will have pharmaceutical operations experience on an isolator line, training or supervisory background, knowledge of GMP/FDA/aseptic standards, and preferred experience with Lean Six Sigma, e-learning platforms, or continuous improvement methodologies.

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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