The Analytical Technical Trainer will spearhead the training Quality Lab personnel on analytical assays and method transfers. This role is integral in ensuring that all personnel are adept at executing their tasks accurately and efficiently. The Trainer will oversee the laboratory training program, ensuring alignment with cGMP regulations and maintaining critical laboratory accreditations such as ISO 17025 and NSF.
Roles and Responsibilities:
Testing
Provide support for routine testing and thorough review of raw materials, stability, and finished product samples, ensuring adherence to quality standards.
Act as a resource for resolving out-of-specifications (OOS) issues within the Quality Laboratory.
Training
Conduct comprehensive training needs assessments for Quality Laboratory personnel, maintaining detailed training matrices to track progress and identify areas for improvement.
Develop and deliver tailored training modules to meet the evolving needs of the laboratory, covering the testing of raw materials, intermediates, and finished products.
Facilitate the onboarding program for new laboratory personnel, ensuring a smooth transition and integration into the team.
Coordinate a quarterly development program, incorporating webinars, scientific articles, and SME presentations to keep laboratory personnel abreast of the latest technological and scientific advancements.
Identify and cultivate Subject Matter Experts (SMEs) in various laboratory techniques, enhancing the overall training and skill level of laboratory personnel.
Design, implement, and oversee a "Train-the-Trainer" program to empower experienced staff to become effective trainers.
Deliver hands-on instrument training and engaging live lectures to ensure comprehensive skill development across the laboratory team.
Compliance
Establish a competency program to periodically assess and confirm personnel expertise, identifying and addressing re-training needs to maintain laboratory accreditations such as ISO 17025.
Support laboratory management in conducting re-training sessions to address corrective and preventive actions (CAPAs) resulting from laboratory investigations.
Method Transfer
Lead the technical support for transferring analytical methods to the Quality Control group, ensuring seamless integration and adherence to quality standards.
Mentor and train Chemists in the proper execution and interpretation of validation studies, fostering a culture of continuous learning and improvement.
Provide robust support for the Calibration Program, ensuring accurate and reliable instrument performance.
Support of Laboratory Systems
Administer the Empower program, developing "Superusers" to support business needs across all laboratory shifts and ensuring compliance with laboratory data integrity expectations from regulatory agencies.
Assist in maintaining a robust instrumentation parts and consumables system, ensuring the availability of critical supplies.
Support the in-house instrumentation preventative maintenance (PM) program, including coordination of third-party services to ensure optimal instrument performance.
General
Undertake additional duties as assigned by Supervisor(s) or designee, contributing to the achievement of company goals and objectives.
Foster effective communication and collaboration with other departments, promoting a cohesive and efficient team environment.
Maintain regular attendance to ensure consistent and reliable support for laboratory operations.
Minimum Requirements:
Provide training support to first and second shift Quality Laboratory personnel with minimal disruption to lab performance.
Demonstrate proficiency in analytical methods for chromatographic, spectroscopic, titrimetric, and wet chemistry analyses.
Exhibit expertise in laboratory software such as Empower and Tiamo, used for chromatographic and spectroscopic methods as well as wet chemistry.
Possess strong troubleshooting skills for laboratory instruments such as HPLC and GC.
Display a solid understanding of laboratory instrumentation including FTIR, HPLC, ICP, GC, UV-Vis, LC-MS, GC-MS, ICP-MS, HPTLC.
Have knowledge of statistical techniques, including data trend analysis and design of experiments, to support method validation and quality control efforts.
Show proficiency in reviewing and interpreting laboratory data, ensuring accuracy and reliability.
Demonstrate a thorough understanding of routine laboratory operations and industry regulations, including FDA and ICH guidelines.
Communicate effectively and cooperatively at all levels within the organization.
Exhibit strong verbal and written communication skills.
Thrive in a dynamic, fast-paced environment, demonstrating the ability to adapt and excel under pressure.
Education and Experience:
Hold a bachelor's degree in Analytical Chemistry, General Chemistry, Biochemistry, Chemical Engineering, or a related field (strongly preferred).
Possess prior experience as a trainer or in the education field (preferred).
Have 10 years of experience performing analytical methods for nutraceuticals and/or pharmaceutical testing in a GMP environment.
Strong social skills that would allow the individual to flourish in large presentation settings and implement changes to training plans.
Comfortable educating others and being a "trainer" for lab staff with a passion for continuing education.
Proficient in Empower chromatography database software.
Strong analytical skills in laboratory techniques and fundamentals such as titration, gravimetric methods, separation techniques, and others.
Knowledge of industry regulations, FDA, and ICH guidelines to ensure compliance and maintain Laboratory Accreditations.
Training certificate of education credits is preferred.
Salary and Benefits:
Salary range: $90k-$100k
Discretionary bonus potential worth up to 12% of year-to-date earnings, prorated for the first year
Relocation assistance including temporary housing, transportation/storage of personal items, and paid site visits
Work Schedule:
Hours: Monday to Friday, 8:30 AM to 5:00 PM
Eligibility:
Only accepting candidates who are green card holders or U.S. citizens (no visas or sponsorship now or in the future)