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Manufacturing - 1st Shift CGMP Biomanufactuirng Training Specialist

Mindlance

Madison, WI

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JOB DETAILS
SKILLS
Address Management, Asepsis, Biology, Biotech and Pharmaceutical, Chemistry, Cleanroom, Content Development, Current Good Manufacturing Practice (cGMP), Documentation, Environmental Health, Equipment Validation, FDA (Food and Drug Administration), Housekeeping/Cleaning, ISO (International Organization for Standardization), Identify Issues, Laboratory, Laboratory Equipment, Maintain Compliance, Manufacturing, Materials Analysis, Medical Equipment, Metrics, Microsoft Excel, Microsoft Office, Microsoft Word, Needs Assessment, Performance Management, Problem Solving Skills, Quality Assurance, Quality Management, Regulations, Safety Compliance, Safety/Work Safety, Standard Operating Procedures (SOP), Systems Maintenance, Time Management, Training Program Development, Training/Teaching, Validation Plan
LOCATION
Madison, WI
POSTED
5 days ago

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
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
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.

EEO:

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”

About the Company

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Mindlance