Team Leader Quality Assurance

$95,000 - $110,000/Yr

Aveva Drug Delivery Systems - Miramar, FL

Full-time - Mid Level

Miramar, FL

Chemical Manufacturing

About the position

The Senior Training and Development Associate at Aveva Drug Delivery Systems Inc. is responsible for designing, developing, and implementing training programs that ensure compliance with Current Good Manufacturing Practices (cGMP) and company policies. This role collaborates with cross-functional teams to align training with regulatory requirements and organizational standards, focusing on instructional design within the pharmaceutical industry.

Responsibilities

• Develop and implement comprehensive training programs focused on cGMP requirements to support Quality and Compliance across the organization.
• Collaborate with subject matter experts (SMEs) to conduct needs assessments, define learning objectives, and identify performance gaps in cGMP knowledge.
• Design, develop, and maintain instructional materials such as eLearning modules, training manuals, SOP guidelines, job aids, video scripts, and assessments to facilitate effective learning.
• Create engaging, learner-centered content using a variety of instructional methods, including instructor-led training (ILT), eLearning, blended learning, and microlearning.
• Regularly update training materials to reflect changes in regulatory guidelines, SOPs, and industry best practices.
• Conduct training sessions for new hires and existing employees, ensuring comprehension and adherence to cGMP standards.
• Evaluate the effectiveness of training programs by collecting feedback, analyzing results, and making necessary adjustments to improve learning outcomes.
• Manage the content in the Learning Management System (LMS), ensuring all training records are up-to-date, accessible, and compliant with documentation requirements.
• Provide mentorship and guidance to junior instructional designers and training coordinators within the department.
• Collaborate with Quality Assurance to ensure cGMP training is consistent with Aveva's SOPs and meets FDA, ISO, and other regulatory body requirements.

Requirements

• Bachelor's degree in Instructional Design, Education, Quality Management, or a related field; Master's degree preferred.
• Minimum 3-5 years of experience in training development, instructional design, or related roles within a cGMP-regulated industry, preferably in pharmaceuticals.
• Proficiency in eLearning authoring tools (e.g., Articulate Storyline, Adobe Captivate) and Learning Management Systems (LMS).
• Strong understanding of cGMP requirements, regulatory guidelines, and compliance in the pharmaceutical industry.
• Excellent written and verbal communication skills with strong attention to detail.
• Ability to work independently and manage multiple projects with competing deadlines.
• Familiarity with instructional design models (e.g., ADDIE, Kirkpatrick's Evaluation Model) and adult learning principles.

Nice-to-haves

• Experience with data analysis for training evaluation.
• Project management skills.

Benefits

• Competitive salary ranging from $95,000 to $110,000 per year.