Pharma Training Specialist | cGMP, LMS & Bilingual

FITS, LLC; Añasco (PR); On-site; USD 42,000 - 60,000; Full time

Benefits offered by this job

Excellent customer service culture

Job summary

FITS, LLC is seeking a training professional to design, develop, and evaluate training materials for instructional soundness and learning courses in the pharmaceutical and medical device sectors. You will work with Engineering and other functions to deliver cGMP training that supports client operations.

You will certify employees, maintain training plans and curricula, and keep training records in the LMS. A strong focus on GMP/GDP compliance and documentation is essential to excellence.

Qualifications

• Bachelor’s Degree and at least 1 year of exposure in Pharmaceutical or Medical Device industry.
• Bilingual: English and Spanish.
• Shift: Administrative and according to business needs.
• Experience in GMP, GDP and regulated industry requirements.

Responsibilities

• Designs, develops, and evaluates training materials and training programs for instructional soundness, and instructional materials for learning courses.
• In conjunction with Engineering and other functional areas, designs and delivers technical and cGMP training programs to support client operations.
• Evaluates procedure changes; determine target audiences and training methodologies according to the procedure impact.
• Certifies employees to perform their job responsibilities and assure that employee training plans and curricula are updated.
• Maintains the Learning Management System and files training related documentation following the records retention process.
• Assures that training activities are documented in the Learning Management System.
• Maintains updated and readily available training documentation for all employees according with procedures and regulations.
• Assures that only well trained and qualified employees perform the job.
• Provides information of Certified and Trained employees to the supervisors.
• Conducts spot audits to assure compliance of the training system.
• Assists with documentation management distribution and compliance for the operations areas
• Conduct investigations on Non-conformances related to the training system and human errors
• Provide new hires and client induction related trainings.

Skills

Bilingual: English and Spanish

GMP

GDP

Regulated industry requirements

Customer service mindset

Education

Bachelor's Degree

Job description

FITS, LLC is seeking a training professional to design, develop, and evaluate training materials for instructional soundness and learning courses in the pharmaceutical and medical device sectors. You will work with Engineering and other functions to deliver cGMP training that supports client operations.

You will certify employees, maintain training plans and curricula, and keep training records in the LMS. A strong focus on GMP/GDP compliance and documentation is essential to excellence.