Job Summary:

Under moderate supervision, trains production department employees.  Ensure employees are qualified within the training system. Train and qualify current and new employees. Assist with new hires orientation.

Key Responsibilities:

• Delivers and oversees training and qualification of department personnel on all required documents, collaborating with subject matter experts as needed to ensure accuracy and effectiveness.
• Actively supports the onboarding of new hires, ensuring a smooth integration with zero deviations and no safety incidents through strong adherence to training and compliance standards.

• Demonstrate curiosity and creativity in identifying and managing training solutions to ensure compliance with company policies and procedures.
• Serve as the primary point of contact for submission, review, and verification of training records, ensuring completeness and accuracy.
• Collaborate with procedure authors to assess training impacts and ensure timely communication of training requirements to affected employees.
• Schedules, coordinates, and tracks training for new and revised documents, ensuring timely completion and achieving 100% compliance.
• Develop, revise, and maintain training materials, presentations, assessments, and qualification tools to support effective employee learning.
• Coordinate and administer employee training assignments within the Training Management System (TMS), ensuring timely completion and accurate documentation.
• Support cross-functional business initiatives and site projects by coordinating training requirements and ensuring timely implementation.
• Actively participate in monthly walkthroughs of Production and warehouse areas in collaboration with Production teams.
• Partner with Environmental Health & Safety (EH&S) and Production to support monthly safety initiatives, including “EHS Perspectives.”
• Demonstrate strong safety leadership by promoting safe behaviors, proactively coaching colleagues, and reinforcing a safety-first culture.
• Support internal and external audits by generating and customizing training reports as required.
• Maintain and enhance SharePoint tools to provide Production supervisors and managers with visibility into employee training status, particularly during the transition from manual processes to TMS (Difgen).
• Assign training documents (e.g., SOPs, WIs, STPs, PPMs) to Production employees in alignment with defined training plans.
• Create, revise, and maintain employee qualification modules and training curricula to support operational readiness and compliance.
• Maintain qualification status and competency matrices to ensure only qualified personnel are assigned to GMP manufacturing activities.
• Effectively prioritize workload to meet deadlines while utilizing resources efficiently.
• Drive training completion by influencing a strong culture of compliance and accountability.

Compliance & Operational Excellence:

• Perform all responsibilities in accordance with established regulatory, GMP, GDP, compliance, and safety requirements.
• Always Adhere to the company’s Code of Conduct and Business Ethics.
• Support and embody corporate values: Innovate, Evolve, and Excel.
• Demonstrate a high level of knowledge in Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Work collaboratively as part of a team to achieve departmental and organizational goals.
• Complete assigned tasks within scheduled work hours to minimize overtime and maintain operational efficiency.
• Perform additional duties assigned to support business needs.

Job Requirements

• Education
  • Associates (A.A./ A.S) or Bachelor’s (B.A./B.S.) degree in Science, Business, or related discipline preferred
• Experience
  • A.S. or B.S. degree – A minimum of 3 years of relevant pharmaceutical experience in a fast-paced lean Manufacturing/Packaging organization in a GMP environment
  • A minimum of 5 years of relevant pharmaceutical industry experience in a fast-paced lean Manufacturing/Packaging organization in a GMP environment will be considered for candidates with less than an associate’s degree.
  • Experience in training manufacturing personnel would be preferred.

• Knowledge, Skills and Abilities
  • Ability to work within a diverse team environment (as part of a team) as demonstrated through previous work experience.
  • Knowledge of Aveva’s current packaging or manufacturing processes
  • Knowledge of FDA, cGMPs, and SOPs related to job requirements.
  • Ability to read English and interpret documents and batch records
  • Ability to write and word process English
  • Ability to speak English effectively and communicate with all company employees
  • Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions and decimals
  • Must possess intermediate to advanced Microsoft Excel, Word, PowerPoint and Access software knowledge
  • Highly organized and detail oriented
  • Demonstrated ability to handle multiple priorities in a fast-paced environment.
  • Flexible schedule to assist with training and qualification in all 3 shifts
  • The employee is frequently required to walk or stand
  • The normal work environment for this position is an office/manufacturing setting
  • The noise level in the work environment is usually moderate

Job Requirements

• Education
  • Associates (A.A./ A.S) or Bachelor’s (B.A./B.S.) degree in Science, Business, or related discipline preferred
• Experience
  • A.S. or B.S. degree – A minimum of 3 years of relevant pharmaceutical experience in a fast-paced lean Manufacturing/Packaging organization in a GMP environment
  • A minimum of 5 years of relevant pharmaceutical industry experience in a fast-paced lean Manufacturing/Packaging organization in a GMP environment will be considered for candidates with less than an associate’s degree.
  • Experience in training manufacturing personnel would be preferred.