GXP Trainer

Job Description

LHH is hiring for a GXP (Good Practice) Trainer in the Silver Springs, MD who will be responsible for designing, developing, and delivering training programs related to regulatory compliance standards such as Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP). Their primary goal is to ensure that employees in pharmaceutical, biotechnology, and medical device companies understand and adhere to these regulations to maintain product quality, safety, and efficacy.

The job description for a GXP Trainer may include the following responsibilities:

Developing training materials: Creating training materials such as presentations, handouts, manuals, and e-learning modules that effectively communicate regulatory requirements and best practices.

Conducting training sessions: Leading classroom or online training sessions to educate employees on GXP principles, procedures, and guidelines. This may involve delivering lectures, facilitating discussions, and conducting practical exercises.

Customizing training programs: Tailoring training programs to address specific roles, departments, or areas of focus within the organization. This could involve designing specialized training modules for quality control, manufacturing, clinical research, or other functional areas.

Assessing training needs: Identifying gaps in employee knowledge or skills related to GXP compliance through training needs assessments, feedback surveys, and performance evaluations.

Monitoring training effectiveness: Evaluating the impact of training programs by assessing participant comprehension, retention, and application of GXP principles in their daily work activities.

Updating training content: Keeping training materials and programs up-to-date with the latest regulatory requirements, industry standards, and best practices to ensure compliance and relevance.

Collaborating with stakeholders: Working closely with cross-functional teams including quality assurance, regulatory affairs, compliance, and operations to align training initiatives with organizational goals and priorities.

Providing regulatory guidance: Serving as a subject matter expert on GXP regulations and standards, offering guidance and advice to employees and management on compliance issues and interpretation of regulatory requirements.

Supporting inspections and audits: Assisting with preparations for regulatory inspections and audits by ensuring employees are trained and prepared to demonstrate compliance with GXP regulations.

Continuous improvement: Identifying opportunities to enhance training effectiveness and efficiency through process improvements, technology adoption, and innovative instructional design techniques.

Qualifications for a GXP Trainer may include a bachelor's degree in a relevant field such as pharmaceutical sciences, life sciences, or education, along with several years of experience working in a regulated industry (pharmaceuticals, biotechnology, medical devices) with a focus on GXP compliance. Strong communication, presentation, and instructional design skills are essential, as well as a solid understanding of regulatory requirements and industry standards related to GXP. Additionally, certifications such as Certified GMP Professional (CGMP) or Certified GXP Compliance Professional (CGXP) may be preferred or required depending on the employer.

Pay Details: $26.00 to $29.00 per hour

Search managed by: Kelly Kirst

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.