CGMP BIOMANUFACTURING TRAINING SPECIALIST (NIGHT SHIFT)

Location: Madison, Wisconsin | Employment type: Contract | Worksite: On-Site

About the role

This position works with the Training Manager, cGMP Biomanufacturing to organize and present in-person training sessions on SOPs, cGMP processes, compliance, and Environmental Health and Safety to the cGMP BioManufacturing Group. The role involves assisting with developing content and formatting training materials, developing and administering training programs, assessing training and development needs, and helping individuals and groups develop skills, safety, and knowledge.

Responsibilities

• Track and monitor training, providing timely, accurate information and 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 and work with managers to address learning issues or new educational needs.
• Assist in developing qualifications and evaluations to ensure training effectiveness in the Manufacturing department.
• Design and develop training, including structured job-specific tasks, SOP training, FDA cGMP, Environmental Health & Safety regulations, and general work skills.
• Revise materials based on assessment and evaluation findings.
• Partner and collaborate with Subject Matter Experts to identify needs, target audiences, and desired performance standards.
• Assist in improvements for safety and provide on-the-floor manufacturing support.
• Assist the Quality Assurance department with SOP training as needed.
• Participate in team meetings.
• Track and review training records for accuracy and completeness.
• Inform personnel of communications, decisions, policies, and matters affecting their performance, attitudes, and results.
• Maintain the 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 the execution of equipment qualification/validation protocols, as required.
• Ability to work scheduled shift (night shift) and other off-shift coverage as required.
• Other duties as assigned.

Requirements

• B.S./B.A. in Biology, Chemistry, or other related scientific field, with a minimum of 1-2 years’ experience in related laboratory work.
• BioManufacturing or other Pharmaceutical/Medical Device experience.
• Cleanroom, aseptic technique, and/or general lab equipment experience.
• cGMP, Good Documentation Practices (GDP), and Good Laboratory Practices (GLP) knowledge.
• Experience following standard operating procedures.
• Experience operating, maintaining, and troubleshooting Biomanufacturing-related equipment.

Preferred Qualifications

• Commercial BioManufacturing experience or other Pharmaceutical/Medical Device experience.
• Prior ISO 6/7/8 cleanroom experience.
• Prior dedicated training experience.

Skills

• Experience with Trackwise, ComplianceWire, or other electronic tracking software.
• Ability to work within ISO 6/7/8 cleanroom environments.
• Proficiency in Excel, Word, and other MS Office applications.
• Strong mathematical skills (addition, subtraction, multiplication, division) and ability to record, balance, and check results for accuracy.
• Ability to peer-review data to ensure it is well-organized with complete documentation.
• Ability to understand and independently apply cGMPs to everyday work regarding documentation and equipment use.
• Ability to operate within a cleanroom environment (ISO 6/7/8) and provide on-the-floor support.

Pay

$25–29/hour, depending on experience.

Schedule

Night shift; ability to work scheduled shift and other off-shift coverage as required.