Biomanufactuirng Training Specialist

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 neededRevises 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*

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, were obsessed with where it can take you. To us, its about more than simply accepting your next job opportunity. Its the fuel that powers every next step of your life. Its the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your lifejust ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice ( .

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center. Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.