Aseptic Training & Compliance Specialist

Bausch & Lomb GmbH

Tampa (FL)

Hybride

USD 52 000 - 60 000

Plein temps

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Résumé du poste

Bausch + Lomb is seeking a Training Certification Specialist for 1st shift in Tampa, FL. You will develop and manage aseptic training and certification programs, deliver instructor-led and VR modules, and qualify personnel for cleanroom access.

Requirements include 4+ years of pharmaceutical cleanroom experience, strong knowledge of cGMPs, and excellent organizational and coaching abilities.

Qualifications

  • High School diploma.
  • Associate's degree in science or related field preferred.
  • Detail oriented and highly organized.
  • Effective written and verbal communication skills.
  • Possess interpersonal skills, time management and follow through abilities.
  • Effective problem solver with solid leadership abilities.

Responsabilités

  • Develop, coordinate, and maintain aseptic training and certification programs.
  • Deliver instructor-led classroom training, practical demonstrations, virtual reality training modules, and hands-on assessments.
  • Conduct new hire aseptic qualification training for personnel requiring cleanroom access.
  • Support and administer annual recertification programs and retraining activities.
  • Evaluate personnel competency through written exams, practical assessments, and observation-based audits.
  • Coordinate operator qualification and certification activities associated with media fills and aseptic interventions.
  • Maintain certification records and training databases.
  • Perform routine observations and audits of personnel working in Grade A/B and Grade C/D environments.
  • Monitor compliance with gowning requirements, aseptic technique, cleanroom behaviors, and contamination control procedures.
  • Document observations and provide coaching, corrective actions, and follow-up training when deficiencies are identified.
  • Support investigation activities related to aseptic technique deviations and environmental monitoring trends.
  • Coach employees on aseptic practices, contamination prevention, first-air protection, and cleanroom discipline.
  • Serve as a subject matter expert for aseptic processing and contamination control.
  • Partner with supervisors and managers to identify training needs and performance gaps.
  • Promote a culture of quality, compliance, and continuous improvement.
  • Support department projects as assigned.
  • Perform other tasks, projects, and duties as assigned.

Connaissances

Aseptic training
Program management
Training design
cGMP knowledge
Leadership

Formation

High School diploma
Associate's degree (preferred)

Description du poste

Bausch + Lomb is seeking a Training Certification Specialist for 1st shift in Tampa, FL. You will develop and manage aseptic training and certification programs, deliver instructor-led and VR modules, and qualify personnel for cleanroom access.

Requirements include 4+ years of pharmaceutical cleanroom experience, strong knowledge of cGMPs, and excellent organizational and coaching abilities.

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