Operations Trainer and Compliance Coordinator

Description

 We are seeking a highly organized, engaging, and detail-oriented Operations Trainer to support the Operations Team at Phlow Corp. Reporting to the Director of Operations, this role is responsible for developing, coordinating, delivering, and monitoring training programs that build employee capability, reinforce safe and compliant execution, and support consistent operational performance. The successful candidate will partner with Operations leadership and cross-functional groups to ensure Operations personnel are qualified to perform assigned duties in accordance with current Good Manufacturing Practice (cGMP), FDA requirements, company policies, and approved procedures.

Training Program Management:

• Develop and deliver effective onboarding, qualification, refresher, and skills-development programs for the Operations Team in accordance with cGMP, FDA requirements, approved procedures, and company policies.
• Design, update, and maintain Operations training materials, including curricula, lesson plans, presentations, job aids, knowledge checks, and practical qualification assessments. 
• Maintain a comprehensive Operations training and qualification schedule, ensuring team members complete required training and certifications before independently performing assigned tasks.
• Coordinate classroom, hands-on, vendor-led, and train-the-trainer sessions to strengthen technical capability, procedural adherence, safety, and operational readiness.

Compliance Monitoring:

• Support Operations leadership in maintaining training readiness and adherence to applicable pharmaceutical regulations, including cGMP, FDA, DEA, and other relevant requirements.
• Conduct routine training observations, knowledge checks, and qualification assessments to verify training effectiveness and alignment with approved procedures and regulatory requirements.
• Support internal and external audits by ensuring Operations training records, qualification documentation, and certifications are current, accurate, and audit-ready.
• Partner with Safety, Quality Assurance and Operations leadership to incorporate approved procedural, regulatory, and process changes into Operations training programs.

Record Keeping and Documentation:

• Maintain accurate and detailed records of Operations employee training, qualifications, certifications, and retraining requirements.
• Track Operations training progress and qualification status, follow up on overdue assignments, and escalate gaps that could affect staffing or operational readiness.
• Generate routine reports and metrics on Operations training completion, qualification status, effectiveness, and identified capability gaps for Operations leadership and other stakeholders.

Cross-Departmental Collaboration:

• Work closely with Operations leaders, subject matter experts, Human Resources, Quality Assurance, Environmental Health and Safety, and other functions to align training with business needs and regulatory requirements.
• Provide coaching and support to Operations supervisors, managers, subject matter experts, and designated trainers to promote consistent training delivery and employee qualification.
• Review and provide training-focused input on SOPs, work instructions, batch records, and other controlled documents that affect Operations personnel.

Continuous Improvement:

• Regularly evaluate Operations training programs using feedback, assessment results, deviations, observations, and performance trends, and recommend improvements.
• Stay informed about adult-learning methods, pharmaceutical manufacturing practices, and applicable regulatory expectations to continuously improve Operations training.

The salary range for this position is $80,000 to $105,000, with the final offer determined based on factors such as the candidate's experience, qualifications, skills, and education. In addition to a competitive base salary, this position is eligible to participate in Phlow's bonus and stock option programs. Phlow also offers a comprehensive benefits package that includes medical, life, and disability insurance; retirement savings plans; paid time off and company holidays; and education-related benefits. Many of these programs are fully funded or significantly subsidized by the company, reflecting our commitment to supporting the health, well-being, and professional development of our employees.  

Requirements

Education:

• Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Engineering, Education, Business Administration, or a related field; equivalent relevant experience may be considered.

Experience:

• Minimum of 2-3 years of experience in operations, manufacturing, training, or qualification within a pharmaceutical manufacturing or other regulated industry.
• Working knowledge of FDA regulations, cGMP requirements, controlled documentation, and training practices in a regulated environment is highly preferred.
• Experience developing and delivering instructor-led, hands-on, and competency-based training is required.
• Preferred: Lean Six Sigma experience or certified and /or Continuous Improvement

Skills:

• Strong knowledge of pharmaceutical manufacturing operations, cGMP expectations, and training or qualification practices.
• Excellent facilitation, coaching, presentation, written communication, and interpersonal skills.
• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint) and learning or training management systems.
• Detail-oriented with strong organizational, planning, documentation, and time-management skills.
• Ability to work independently, collaborate across functions, and influence without direct authority.

Additional Requirements:

• Ability to work in a fast-paced Operations environment, manage multiple priorities, and adjust training plans to meet production and staffing needs.
• Strong problem-solving skills and sound judgment when addressing training gaps, qualification issues, and procedural questions.
• A proactive, hands-on approach to employee development, operational readiness, compliance, and 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 increases based on business needs. The role also requires regular presence in Operations and manufacturing areas, subject to applicable gowning and safety requirements.