Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

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: