Training and Compliance Coordinator

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Description

We are seeking a highly organized and detail-oriented Training and Compliance Coordinator to join our team at Phlow Corp. This role is pivotal in ensuring the ongoing training and compliance of all personnel with regulatory standards, company policies, and industry best practices. The successful candidate will be responsible for developing, coordinating, and monitoring training programs to ensure compliance with FDA, GMP (Good Manufacturing Practice), and other relevant regulatory requirements.

Requirements

Training Program Management:

• Develop and implement effective training programs for employees in compliance with GMP, FDA regulations, and company-specific policies.
• Design and update training materials, ensuring they align with current regulatory standards and industry trends.
• Maintain a comprehensive training schedule, ensuring all staff members receive the required training and certifications.
• Coordinate internal and external training sessions, including vendor-led programs, to enhance employee knowledge and compliance.
  
  

Compliance Monitoring

• Ensure all manufacturing and distribution processes are in compliance with relevant pharmaceutical regulations, including GMP, FDA, DEA, and any other applicable laws and guidelines.
• Conduct regular audits and assessments to ensure that training and operational practices align with regulatory requirements.
• Prepare for internal and external audits by ensuring that training records, compliance documentation, and certifications are up-to-date and well-organized.
• Monitor regulatory changes and update training programs accordingly.
  
  

Record Keeping And Documentation

• Maintain accurate and detailed records of employee training, certifications, and compliance status.
• Track training progress and compliance status to ensure all employees meet required qualifications.
• Generate regular reports on training compliance and effectiveness for senior management and regulatory bodies.
  
  

Cross-Departmental Collaboration

• Work closely with the HR, Quality Assurance, and Operations teams to align training efforts with company needs and regulatory requirements.
• Provide guidance and support to department managers to ensure their teams remain compliant with training programs and procedures.
• Assist in the development of SOPs (Standard Operating Procedures) and other documentation to support compliance efforts
  
  

Continuous Improvement

• Regularly review and evaluate training programs for effectiveness and make recommendations for improvements.
• Stay informed about industry best practices and new regulatory requirements to continuously improve the training and compliance programs.
  
  

Education

Experience & Qualifications

• Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Business Administration, or a related field.
  
  

Experience

• Minimum of 2-3 years of experience in a training or compliance role within a pharmaceutical manufacturing or regulated industry.
• Familiarity with FDA regulations, GMP, ISO standards, and other regulatory requirements is highly preferred.
• Experience with training program development and implementation is a must.
  
  

Skills

• Strong knowledge of pharmaceutical industry regulations and compliance standards.
• Excellent communication, presentation, and interpersonal skills.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and training management software.
• Detail-oriented with strong organizational and time management skills.
• Ability to work independently as well as part of a team.
  
  

Additional Requirements

• Ability to work in a fast-paced environment and manage multiple priorities effectively.
• Strong problem-solving skills and the ability to make decisions based on regulatory requirements and company policies.
• A proactive approach to training and compliance challenges, with a focus on continuous improvement.
  
  

Physical Requirements

• Constantly required to see to utilize computer screens and monitors to perform job duties including reading & writing, as well as when presenting information and communicating with others.
• Frequently required to talk or hear to communicate with employees, candidates, vendors, and others, including presenting information in front of groups.
• Frequently required to reach with arms and hands performing repetitive motions and using finger dexterity to work primarily at a computer keyboard and with a mouse.
• Frequently required to sit, and occasionally required to stand or walk to move around primarily in an office environment.
• Occasionally lift and/or move up to 10 pounds.
• This position may require up to 5% travel with occasional increase in travel demands based on business needs.