Biomanufactuirng Training Specialist

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* 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

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* Position Overview:

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* + 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 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, 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

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* Education:

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* + 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*
* + Bio Manufacturing 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 Bio Manufacturing experience or other Pharmaceutical/Medical Device experience

+ Prior ISO 6/7/8 cleanroom experience

+ Prior dedicated training experience

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Experience with Trackwise, Compliance Wire 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.

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