GXP Laboratory Training Program Developer

The GxP laboratory training program developer will develop and implement comprehensive GXP-compliant training programs for Quality Control and Analytical Development laboratories.

 

Responsibilities:

QC Laboratory Training Program

• Training Procedures & Documentation
• Develop SOPs aligned with corporate standards
• Create documentation templates
• Implement documentation management system
• QC Laboratory Onboarding Program
• Design structured onboarding workflow
• Create orientation materials
• Establish competency checkpoints
• Analyst Qualification Program
• Develop On-the-Job Training (OJT) modules
• Create assessment tools and criteria
• Establish qualification tracking system
• Implementation
• Define curriculum structure
• Set up training paths
• Configure tracking and reporting
• Support with Document Control Tasks
• Support with other tasks requested as needed

 Analytical Development Laboratory Program

• Create laboratory-specific training modules

QUALIFICATIONS

Education and Experience

• Bachelor's degree in chemistry/biochemistry, or a closely related field.
• Three to five (3-5) years of experience, including experience with specialized or technical programs or operations; OR an equivalent combination of education, training, and experience. Master's or PhD degree is strongly preferred.

 

Required Knowledge and Skills

Required Knowledge

• Complex to specialized principles, practices, and techniques of chemistry/biochemistry and formulation development.
• Broad understanding of the administration and oversight of chemistry/biochemistry programs, policies, and procedures.
• Complex to specialized methods to resolve chemistry/biochemistry problems, questions, and concerns.
• Broad understanding of applicable chemistry/biochemistry laws, codes, and regulations.
• Understanding of broad testing tools, equipment, and calibration.
• Computer applications and systems related to the work.
• Principles and practices to serving as an effective project team member.
• Methods to communicate with staff, coworkers, and customers to ensure safe, effective, and appropriate operations.
• Correct business English, including spelling, grammar, and punctuation.

Required Skills

• Performing complex to specialized professional-level chemistry/biochemistry duties in a variety of assigned areas.
• Overseeing and administering broad and varied chemistry/biochemistry/formulation functions.
• Ability to operate and train others in analytical instruments and manufacturing equipment.
• Training others in policies and procedures related to the work.
• Serving as a team member and the development and management of projects.
• Operating in a both a team and individual contributor environment.
• Interpreting, applying, and explaining applicable laws, codes, and regulations.
• Preparing advanced to expert functionals reports, correspondence, and other written materials.
• Using initiative and independent judgment within established department guidelines.
• Using tact, discretion, and prudence in working with those contacted during the work.
• Performing effective oral presentations to large and small groups across functional peers and the department.
• Contributing effectively to the accomplishment of team or work unit goals, objectives and activities.
• Establishing and maintaining effective working relationships with various individuals contacted in the work.

Qualifications

Pace® Life Sciences

Pace® makes the world a safer, healthier place. We advance the science of our pharmaceutical and biopharmaceutical customers through the drug development process, from early-phase R&D through clinical trials and GMP commercial product support. For customers with in-house manufacturing and labs, Pace® provides professional services to support their operations.