Biomanufacturing Training Specialist

This position works with Training Manager, cGMP Biomanufacturing to organize and present in-person training sessions on SOPs, cGMP processes, compliance and Environmental Health and Safety to cGMP BioManufacturing Group, assist with developing content and formatting training materials, developing and administering training programs for employees, assesses training and development needs for the cGMP BioManufacturing Group, helps individuals and groups develop skills, safety and knowledge, creates training manuals, monitors training for effectiveness.

Responsibilities

• Track/monitor training and provide timely, accurate information and reports to Training Manager including metrics actions needed to ensure compliance
• Actively lead training sessions
• Assist in conducting needs assessment to determine training requirements. Works with managers to address learning issues, instruction problems, or new educational needs regarding specific employees or groups
• Assist in developing qualifications/evaluations to ensure training effectiveness in the MFG department
• Assist to design and develop training including structured job specific tasks, SOP training, FDA cGMP, Environmental Health & Safety regulations, and general work skills as needed
• Revises materials based on assessment/evaluation findings/outcomes
• Partners/collaborates with Subject Matter Experts to identify need, target audience and desired performance standards
• Assists in improvements for safety and provides on the floor manufacturing support.
• Assist Quality Assurance department with SOP training as needed
• Participate in team meetings
• Track/review training records for accuracy and completeness.
• Informs personnel of communications, decisions, policies and all matters that affect their performance, attitudes and results.
• Maintain effectiveness of Quality system as it pertains to cGMP and training requirements
• Assists in general cleanroom housekeeping and adherence to 5S standards
• Assist in execution of equipment qualification/validation protocols, as required

Qualifications

B.S./B.A. in Biology, Chemistry or other related scientific field, with minimum of 1-2 years’ experience in related laboratory work

Experience: Required

BioManufacturing or other Pharmaceutical/Medical Device experience

Clean room, aseptic technique, and/or general lab equipment experience

cGMP, Good documentation practices (GDP), Good Laboratory Practices (GLP) knowledge

Following standard operating procedures

Experience operating, maintaining and troubleshooting Biomanufacturing-related equipment