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.
Pace® Life SciencesPace® 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.
