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.