JOB SUMMARY
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.
Responsibilities include:
Training Program Management
- 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.
cGMP Compliance
- 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.
Curriculum Development
- 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.
Employee Qualification and Development
- 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.
Documentation and Reporting
- 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.
Continuous Improvement
- 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.
Job Requirements and Qualifications:
Education: High school diploma or G.E.D. required, Bachelor's Degree or above in Chemistry, Biological Sciences, or related discipline preferred
Experience: 2 plus years experience in cGMP Manufacturing environment required, 1 plus year supporting training in cGMP Manufacturing environment preferred
WHY JOIN SPL?
Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential.
Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more!
SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.
Skills Required
- High school diploma or G.E.D.
- Bachelor's degree in Chemistry, Biological Sciences, or related discipline
- 2+ years experience in a cGMP manufacturing environment
- 1+ year supporting training in a cGMP manufacturing environment
- Experience maintaining a Learning Management System (LMS) and training records
- Knowledge of cGMP, FDA, ICH, and global regulatory standards
- Experience supporting internal/external audits and regulatory inspections with training documentation
- Experience developing training materials, assessments, and SOP-based training modules with SMEs
- Ability to track training compliance metrics and prepare reporting dashboards
What We Do
Scientific Protein Laboratories (SPL) is a world leader in biosourced pharmaceuticals, specializing in the development and cGMP-compliant manufacturing of high-quality active pharmaceutical ingredients (APIs). The company is among the largest commercial suppliers of pancreatic enzymes, heparin and its analogs, and other naturally derived products, serving the pharmaceutical, veterinary, and food industries globally.
