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CGMP Bio-manufactuirng Training Specialist

Aditi Consulting

Madison, WI

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JOB DETAILS
SALARY
$27–$29.81 Per Hour
SKILLS
Address Management, Artificial Intelligence (AI), Asepsis, Automotive Automation, Biology, Biotech and Pharmaceutical, Check Processing, Chemistry, Cleanroom, Consulting, 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, Messaging Technology, Metrics, Microsoft Excel, Microsoft Office, Microsoft Word, Needs Assessment, Organizational Skills, Performance Management, Problem Solving Skills, Purchasing/Procurement, Quality Assurance, Quality Management, Regulations, Safety Compliance, Safety/Work Safety, Schedule Development, Short Messaging Service (SMS), Speech Technology, Standard Operating Procedures (SOP), State Laws and Regulations, Systems Maintenance, Telephony, Time Management, Training Program Development, Training/Teaching, Validation Plan
LOCATION
Madison, WI
POSTED
5 days ago
Payrate: $27.00 - $29.81/hr.
 
Summary:
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.
 
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.
 
Pay Transparency: The typical base pay for this role across the U.S. is: $27.00- $29.81/hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, denmatch, lifeion benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match,  life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law. 

Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC’s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.

Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying “STOP” to messages or by contacting privacy@aditiconsulting.com.
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Aditi Consulting