Biomanufacturing Training Specialist (cGMP)

Biomanufacturing Training Specialist (cGMP) Radiance Technologies LLC Madison, WI Job Details Contract $27.93 - $29.81 an hour 18 hours ago Qualifications Biology EHS Laboratory equipment maintenance Bachelor of Science Spreadsheets Equipment troubleshooting Cleanroom protocols Manufacturing standard operating procedures Manufacturing facility Laboratory standard operating procedures Equipment maintenance Technical troubleshooting support Productivity software Data accuracy checks Standard operating procedures (SOPs) FDA regulations Full Job Description This position works with Training Manager, cGMP Bio-manufacturing to organize and present in-person training sessions on SOPs, cGMP processes, compliance and Environmental Health and Safety to cGMP Bio-manufacturing Group, assist with developing content and formatting training materials, developing and administering training programs for employees, assesses training and development needs for the cGMP Bio-manufacturing Group, helps individuals and groups develop skills, safety and knowledge, creates training manuals, monitors training for effectiveness.

Specific Duties, Activities & Responsibilities Track/monitor training and provide timely, accurate reports to the Training Manager, including metrics and actions needed to ensure compliance. Actively lead training sessions. Assist in conducting needs assessments to determine training requirements; work with managers to address learning issues, instruction problems, or new educational needs. Assist in developing qualifications/evaluations to ensure training effectiveness in the MFG department. Assist in designing and developing training, including structured job-specific tasks, SOP training, FDA cGMP, Environmental Health & Safety regulations, and general work skills. Revise training materials based on assessment/evaluation findings and outcomes. Partner/collaborate with Subject Matter Experts (SMEs) to identify needs, target audiences, and desired performance standards. Assist in safety improvements and provide 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. Inform personnel of communications, decisions, policies, and matters affecting their performance, attitudes, and results. Maintain effectiveness of the Quality system as it pertains to cGMP and training requirements. Assist 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. Perform other duties as assigned. Education

B.S./B.A.

in Biology, Chemistry, or other related scientific field Minimum of 1-2 years of experience in related laboratory work Experience Required Bio-manufacturing or other Pharmaceutical/Medical Device experience Clean room, aseptic technique, and/or general lab equipment experience cGMP, Good Documentation Practices (GDP), and Good Laboratory Practices (GLP) knowledge Experience following standard operating procedures (SOPs). Experience operating, maintaining, and troubleshooting bio-manufacturing-related equipment. Preferred Commercial Bio-manufacturing or other Pharmaceutical/Medical Device experience Prior

ISO 6/7/8

cleanroom experience Prior dedicated training experience Experience with Trackwise, ComplianceWire, or other electronic tracking software

Technical Requirements:

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 daily work regarding documentation and equipment use Ability to operate within a clean room environment (ISO 6/7/8) and provide on-the-floor support

Pay:

$27.93 - $29.81 per hour

Work Location:

In person