Lead Ops Training Coordinator (8hr, 2nd shift, Monday-Friday)

Work Schedule

Environmental Conditions

Job Description

We are looking for a proactive Ops Training Coordinator. You will assist in developing and coordinating a robust training plan and handle documentation systems on our start-up line and maintain thereafter. Your role ensures staff are well-trained. Shift hours are 6pm - 2am, Monday-Friday

Location

Greenville, NC

Key Responsibilities:

Training Program Development:

• Design, develop, and update comprehensive training programs for Steriles East 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 recruits and ongoing training for existing employees.

• Coordinate with external trainers and consultants as needed.

• Train new and current employees on tasks vital to manufacture drug products in an aseptic filling area, including but not limited to:

  • Cleaning cGMP Areas

  • Parts Preparation

  • Filter Integrity Testing

  • Operating Parts Washers and Autoclaves

  • Performing Tray Loading (Vial Line)

  • Performing Glass Loading (Vial Line)

  • Operating the Filling Isolator

  • General Material Handling

  • General Control Room Operations

Compliance and Documentation:

• Ensure all training activities are documented, and records are maintained accurately.

• Update training records and certifications as required.

• Ensure training aligns with GMP and regulatory standards.

Team Leadership and Development:

• 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 pharmaceutical PFS.

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 East operations and overall efficiency.

Education

• High school diploma/GED is minimally required.

• Bachelor's degree in a relevant subject area is preferred.

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Experience

• Required: Minimum of 2 years of experience in pharmaceutical operations, manufacturing environment or related industry.

• Required: At least 1 year in a training or supervisory capacity. Other roles and responsibilities in a training or educational capacity will be considered.

• Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills, Abilities

• In-depth knowledge of GMP, FDA regulations, and pharmaceutical PFS standards.

• Excellent communication, presentation, and interpersonal skills.

• Strong organizational and project management abilities.

• Proficiency in MS Office and training software.

• Strong Problem-Solving Skills

• Experience with Lean Six Sigma or other continuous improvement methodologies.

• Familiarity with e-learning platforms and digital training tools.

What We Offer:
Compensation
Competitive Pay
Performance Related Bonus where eligible
Annual merit performance-based increase

Excellent Benefits
Medical benefits
Paid Time Off/Annual Leave
Employee Referral Bonus
Career Advancement Opportunities