Associate Lead I - Biomanufacturing, Training

Catalent Pharma Solutions • Madison, WI

1d • Onsite

About The Position

We have an opportunity for an Associate Lead I - Biomanufacturing, Training to join our team. In this role, you will support training compliance and lead training sessions to ensure operational excellence. You will collaborate with managers and subject matter experts to design and deliver effective training programs. This position plays a key role in maintaining quality standards and supporting continuous improvement in a dynamic biomanufacturing environment.

Requirements

• High School Diploma or GED with at least 4+ years of related experience, or an Associate’s degree in STEM with 1+ years of related experience.
• Proficiency in Microsoft Office and ability to learn and use quality and scientific systems such as TrackWise®, ComplianceWire®, JD Edwards®, and Unicorn®.
• Ability to apply current Good Manufacturing Practices principles and best practices to ensure compliant, high-quality execution of procedures.
• Foundational knowledge of manufacturing and laboratory operations with the ability to learn new processes and techniques.
• Experience with deviation investigations, including corrective and preventive actions (CAPAs).
• Experience authoring and editing Standard Operating Procedures and related documentation under guidance.
• Individual must be able to see, hear, read, and write clear English.
• Frequent sitting, standing, walking, reading of written documents, and use of computer monitor screen, reaching with hands and arms, talking, writing, listening.
• Occasional stooping, kneeling, crouching, bending, carrying, grasping.
• Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds.
• Must comply with Environmental Health & Safety responsibilities.

Nice To Haves

• Previous experience training and mentoring others on Good Manufacturing Practice best practices and managing a training program.

Responsibilities

• Support tracking and monitoring of training to provide accurate reports and metrics for compliance.
• Actively lead training sessions for employees.
• Provide input to assess training requirements and work with managers to address learning needs.
• Assist in developing qualifications and evaluations to ensure training effectiveness in the manufacturing department.
• Help design and develop training, including job-specific tasks, SOP training, FDA current Good Manufacturing Practices, Environmental Health & Safety regulations, and general work skills.
• Support authoring of Standard Operating Procedures for new processes, systems, or technologies related to training needs.
• Provide feedback and support revisions of materials based on evaluation findings.
• Collaborate with Subject Matter Experts to identify needs, target audience, and performance standards.
• Assist in safety improvements and provide on-the-floor manufacturing support.
• Assist Quality Assurance with SOP training as needed.
• Participate in team meetings and track/review training records for accuracy.
• Communicate decisions, policies, and information that affect performance and results.
• Assist in evaluating the effectiveness of the Quality system as it relates to cGMP and training requirements.
• Support cleanroom housekeeping and adherence to 5S standards.
• Work scheduled shift and provide off-shift coverage as required.
• Perform other duties as assigned.

Benefits

• Competitive paid time off plus 8 paid holidays.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition reimbursement.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree