Job Title: Biomanufactuirng Training Specialist
Location: Madison, WI- ONSITE
Duration: 4-6 months with possible extensions
Pay: $29.81/HR 
Shift: MON-FRI 8AM – 5pm

Position Overview:

• 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
  

• 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
   

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

• 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:

• 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.

Why Kelly?
Kelly® puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering & scientific talent and services since 1965. And Engineering & Scientific job seekers know Kelly® as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly® to explore opportunities that suit your specific professional interests.

As a Kelly Services employee, you will have access to numerous perks, including:

• Exposure to a variety of career opportunities as a result of our expansive network of client companies 
  

• Career guides, information and tools to help you successfully position yourself throughout every stage of your career
  

• Access to more than 3,000 online training courses through our Kelly Learning Center
  

• Weekly pay and service bonus plans
  

• Group-rate insurance options available immediately upon hire*

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