Training Specialist, QC Lab
Description
Training Specialist, QC Lab Summary
INCOG BioPharma Services is looking for a Quality Control Trainer who will be dedicated to producing the highest quality products for our clients.
This role will be a key member of the INCOG Quality Control laboratory team who has a passion for learning, collaborating, and contributing to the success of our clients. The QC Trainer will be dedicated to the success of the Quality Control team, resulting in the production of the highest quality products for our clients.
The Training Specialist (QC Lab) will develop, standardize, and maintain training programs for laboratory analysts in both chemistry and microbiology disciplines, ensuring materials are current, effective, and aligned with regulatory expectations. This position supports continuous improvement, deviation/CAPA investigations, and the development of subject matter expertise for new instrumentation and methods. The role requires availability to support training needs across all three shifts.
This role may require flexibility to work outside of core business hours. (ie. early mornings or later evenings depending on business needs.)
Essential Job Functions:
· Develop, standardize, and maintain OJT documents and training materials.
· Prioritize training method types (OJT, leader-led, read/sign) based on content and risk.
· Influence and manage the periodic review cycle of training documentation to ensure ongoing accuracy and compliance.
· Support onboarding and training of analysts across all three shifts.
· Train staff on Good Documentation Practices (GDP) in both paper and electronic formats, with emphasis on laboratory application.
· Assist in the development of training programs for new instrumentation, including identifying and cultivating SMEs when none exist.
· Participate in deviation and CAPA investigations to identify training gaps and implement best practices.
· Collaborate with QC leadership to assess training needs and effectiveness.
· Maintain training records in alignment with GxP and regulatory requirements.
· Support audit and inspection readiness through training documentation and delivery.
· Lead the development of new OJT materials in alignment with onboarding of new instrumentation and methods.
· When existing Subject Matter Experts (SMEs) are not available, identify and leverage internal resources, external guidance, and structured programs to cultivate SME expertise and ensure effective training delivery.
Special Job Requirements:
· Bachelor’s degree in Chemistry, Microbiology, or related scientific field.
· 3+ years of experience in a GxP laboratory environment.
· Strong analytical skills with Chemical and/or Microbiological testing methods.
· Strong understanding of GDP in both paper and electronic systems (e.g., LIMS).
· Experience developing and delivering technical training in a regulated environment.
· Ability to work flexible hours to support training across all three shifts.
Additional Preferences:
· Prior leadership experience in GMP QC laboratories supporting pharmaceuticals.
· Familiarity with CAPA/deviation systems and root cause analysis.
· Knowledge of regulatory requirements (FDA, ICH, USP) as they apply to QC labs
· Detail-oriented with a passion for continuous improvement and knowledge sharing.
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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