GMP Training Specialist — Biopharma Manufacturing

BioTalent; Tustin (CA); On-site; USD 35,000 - 47,000; Full time

Job summary

BioTalent is seeking a Manufacturing Trainer to support GMP manufacturing teams across Upstream, Downstream, and Formulation operations. You will deliver high-quality training, drive qualification programs, and reinforce compliance and documentation standards in a regulated biopharmaceutical environment.

You will develop training materials, maintain records, and coach teams to ensure proper execution of processes and adherence to ALCOA+ principles, GDP, and SOPs in a fast-paced facility.

Qualifications

• Associate’s or Bachelor’s degree in a scientific or technical discipline.
• 1-3 years of GMP manufacturing or technical training experience.
• Strong understanding of GMP, GDP, and ALCOA+ principles.
• Experience delivering training, coaching, or employee development programs.
• Strong attention to detail and documentation accuracy.
• Excellent communication and coaching skills.
• Ability to work effectively in a fast-paced GMP manufacturing environment.

Responsibilities

• Deliver classroom, virtual, and hands-on training for Upstream, Downstream, and Formulation manufacturing operations.
• Facilitate on-the-job training (OJT) qualifications and support new hire onboarding activities.
• Develop and maintain training materials, qualification checklists, assessments, and job aids.
• Ensure training content remains aligned with SOPs, current processes, and regulatory requirements.
• Maintain training records and support curriculum updates, retraining initiatives, and qualification tracking.
• Reinforce GMP documentation standards, GDP practices, and ALCOA+ principles across manufacturing teams.
• Provide floor support, coaching, and guidance to ensure proper execution of manufacturing processes and documentation.
• Track training compliance metrics, identify training gaps, and support continuous improvement initiatives.

Skills

GMP manufacturing

Training delivery

Documentation accuracy

Coaching

Regulatory compliance

Attention to detail

Education

Associate’s or Bachelor’s degree in a scientific or technical discipline

Job description

BioTalent is seeking a Manufacturing Trainer to support GMP manufacturing teams across Upstream, Downstream, and Formulation operations. You will deliver high-quality training, drive qualification programs, and reinforce compliance and documentation standards in a regulated biopharmaceutical environment.

You will develop training materials, maintain records, and coach teams to ensure proper execution of processes and adherence to ALCOA+ principles, GDP, and SOPs in a fast-paced facility.