Direct hire role, full benefits including a week off for Christmas, and a 12% bonus potential
Position Summary:
The Technical Trainer will oversee the training of Quality Laboratory personnel on analytical assays and method transfers. This role includes managing the laboratory training program, ensuring compliance with cGMP regulations, and maintaining accreditations such as ISO 17025.
Key Responsibilities:
Testing: Assist with routine testing of raw materials, stability, and finished products; support Out-Of-Specifications investigations.
Training: Assess training needs, maintain training matrices, develop training modules, and support onboarding of new personnel. Implement quarterly development programs and establish a "Train-the-Trainer" initiative.
Compliance: Develop competency programs to evaluate personnel expertise and support re-training in response to CAPAs.
Method Transfer: Lead technical support for method transfers to Quality Control and mentor Chemists in method execution and validation.
Laboratory Systems Support: Administer the Empower program, ensure data integrity, maintain instrumentation systems, and assist with preventive maintenance.
Minimum Requirements:
Expertise in analytical methods (chromatographic, spectroscopic, wet chemistry).
Proficient in Empower Software and troubleshooting HPLC and GC instruments.
Strong understanding of regulatory standards (FDA, ICH) and experience in GLP/GMP environments.
Excellent communication skills and ability to thrive in a fast-paced environment.
Education and Experience:
Bachelor's degree in a relevant field preferred.
Minimum 10 years of experience in analytical testing for nutraceuticals/pharmaceuticals, with prior training experience preferred.