Lead Ops Training Coordinator at Thermo Fisher Scientific

Greenville, North Carolina, United States

Thermo Fisher Scientific Logo
Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
PharmaceuticalsIndustries

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 in training or educational capacity considered)
  • In-depth knowledge of GMP, FDA regulations, and pharmaceutical Isolator line 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

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 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 aseptic processing within Isolator systems
  • 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 CreationTraining DeliveryCompliance DocumentationTeam LeadershipMentoringContinuous ImprovementPerformance MetricsAseptic ProcessingIsolator SystemsRegulatory ComplianceQuality Assurance

Questions & Answers

Common questions about this position

What is the work schedule for this position?

Typical working hours are 8a - 5p, Monday through Friday, with some weekend work possible. It is a first shift (days) schedule.

What qualifications and experience are required for this role?

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

What are the working conditions like?

The role involves office and production floor environments, with environmental conditions restricting hair products, jewelry, makeup, nail polish, perfume, exposed piercings, and facial hair in cleanroom areas. Occasional travel for training and conferences is required.

What salary or compensation does this position offer?

This information is not specified in the job description.

What makes a strong candidate for the Lead Ops Training Coordinator role?

Strong candidates will have pharmaceutical operations experience on an isolator line, training or supervisory background, knowledge of GMP and FDA regulations, 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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