ription / Comment : 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.

Specific Duties, Activities, and Responsibilities :

Track / monitor training and provide timely, accurate information and reports to Training Manager including metrics actions needed to ensure compliance

ctively lead training sessions

ssist in developing qualifications / evaluations to ensure training effectiveness in the MFG department

ssist 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

ssists in improvements for safety and provides on the floor manufacturing support.

ssist 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

ssists in general cleanroom housekeeping and adherence to 5S standards

ssist in execution of equipment qualification / validation protocols, as required

bility to work scheduled shift and other off-shift coverage as required

Other duties as assigned

Education :

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

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

Preferred

Commercial BioManufacturing experience 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 :

bility to work within ISO 6 / 7 / 8 clean room environments

bility to use Excel, Word, and other MS Office applications

bility to add, subtract, multiply, divide and to record, balance, and check results for accuracy

bility to peer review data to ensure data is well organized with complete documentation

bility to understand and independently apply cGMPs to everyday work with regards to documentation and equipment use

bility to operate within a clean room environment (ISO 6 / 7 / 8) and provide on the floor support Start Time : Hours : 8 : 00am to 5 : 00pm Location : 114 726 Heartland Trail 13-4268760 Madison WI 53717 United States Education : dditional Job Details : 1st SHIFT - Mon - Fri 10 AM to 6 PM TRAINING 2 to 6 WEEKS ON 1ST SHIFT - VET ACCORDINGLING.

THIS IS CONTRACT TO HIRE This is NOT an HR position. This position provides guidance and ensures compliance in GMP training practices, documentation and Environmental Health and Safety.

It would be equivalent to a Biomanufacturing / Manufacturing SME who will train new hires on SOPs, cGMPs, best practices etc.

It will be an entry level role. Must have a min of 1-year experience training and GMP. Manufacturing or lab experience preferred. Experience Required :

• Biomanufacturing or other Pharmaceutical / Medical Device experience (REQUIRED)
• Clean room, aseptic technique, and / or general lab equipment experience (PREFERRED)
• cGMP, Good documentation practices (GDP), Good Laboratory Practices (GLP) knowledge (REQUIRED)
• Following standard operating procedures (REQUIRED)

Last updated : 2024-02-24