Biomanufactuirng Training Specialist

Training Coordinator

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.

• 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
• Ability to work scheduled shift and other off-shift coverage as required
• Other duties as assigned

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

• 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

• Commercial Biomanufacturing experience or other Pharmaceutical/Medical Device experience
• Prior ISO 6/7/8 cleanroom experience
• Prior dedicated training experience
• Experience with Trackwise, Compliance Wire or other electronic tracking software

• Ability to work within ISO 6/7/8 clean room environments
• Ability to use Excel, Word, and other MS Office applications
• Ability to add, subtract, multiply, divide and to record, balance, and check results for accuracy
• Ability to peer review data to ensure data is well organized with complete documentation
• Ability to understand and independently apply cGMPs to everyday work with regards to documentation and equipment use
• Ability to operate within a clean room environment (ISO 6/7/8) and provide on the floor support.