Manufacturing Training Coordinator

Scientific Protein Laboratories•Waunakee, WI

7d•Onsite

About The Position

Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team as a Manufacturing Training Coordinator. The Training Coordinator is responsible for developing, coordinating, administering, and maintaining the Manufacturing training program to ensure compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, company policies, and quality standards. This role works closely with the Manufacturing team and other functional departments to ensure manufacturing employees are appropriately trained and qualified to perform their assigned duties.

Requirements

High school diploma or G.E.D. required
2 plus years experience in cGMP Manufacturing environment required

Nice To Haves

Bachelor's Degree or above in Chemistry, Biological Sciences, or related discipline preferred
1 plus year supporting training in cGMP Manufacturing environment preferred

Responsibilities

Coordinate and administer the training programs for manufacturing personnel.
Maintain the Learning Management System (LMS) and training records in compliance with cGMP requirements.
Schedule and track onboarding, refresher, and periodic training activities.
Ensure timely assignment, completion, and documentation of required training curricula.
Monitor training compliance metrics and generate periodic reports for management review.
Ensure all training activities comply with applicable regulatory requirements, including FDA, ICH, and other global regulatory standards.
Support internal and external audits, regulatory inspections, and customer audits by providing training documentation and records.
Maintain training procedures, work instructions, and SOPs related to the training system.
Ensure training records are accurate, complete, and audit-ready.
Collaborate with Subject Matter Experts (SMEs) to develop and update training materials, presentations, assessments, and qualification programs.
Support the creation and revision of SOP-based training modules.
Coordinate effectiveness evaluations to verify employee understanding and competency.
Assist in developing role-based training matrices and qualification requirements.
Coordinate new employee orientation and onboarding programs.
Track employee qualifications, certifications, and requalification requirements.
Support cross-training initiatives to improve workforce flexibility and operational efficiency.
Identify training gaps and recommend corrective actions.
Maintain training databases, matrices, qualification records, and compliance dashboards.
Prepare monthly and quarterly training compliance reports.
Support investigations, deviations, CAPAs, and change controls related to training activities.
Ensure controlled training documents are distributed and archived according to document control procedures.
Evaluate training program effectiveness through metrics, assessments, and feedback.
Recommend and implement improvements to training processes and systems.
Support digitalization and continuous improvement initiatives within the training function.