Work Schedule

First Shift (Days)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, No contact lens allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Work Schedule

First Shift (Days)

Environmental Conditions

Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. allowed.

Job Description

Job Description

The Lead Operations Training Coordinator for Steriles South in Pharmaceuticals is responsible for developing, implementing, and overseeing training programs for the Steriles South operations team. This role ensures that all Operations staff are adequately trained in compliance with regulatory standards and company procedures, fostering a culture of continuous improvement and operational excellence. Typical working hours are 8a - 5p, Monday through Friday, with some weekend work possible.

Key Responsibilities:

Training Program Development:

• 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.

Training Delivery:

• Conduct training sessions for new hires and ongoing training for existing employees.
• Coordinate with external trainers and consultants as needed.

Compliance and Documentation:

• Ensure all training activities are documented and records are maintained accurately.
• Update training records and certifications as required.

Team Leadership and Development:

• 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.

Continuous Improvement:

• 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.

Collaboration:

• 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.

Qualifications:

• 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 isolater 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 pharmaceutical Isolator line standards.
• Excellent communication, presentation, and interpersonal skills.
• Strong organizational and project management abilities.
• Proficiency in MS Office and training software.

Preferred Qualifications:

• Experience with Lean Six Sigma or other continuous improvement methodologies.
• Familiarity with e-learning platforms and digital training tools.

Working Conditions:

• Office and production floor environments.
• Occasional travel for training and conferences.