Biomanufacturing Training Specialist

Aditi Consulting

Madison, WI

JOB DETAILS
SALARY
$29.81–$29.81 Per Hour
SKILLS
Address Management, Artificial Intelligence (AI), Asepsis, Automotive Automation, Biology, Biotech and Pharmaceutical, Chemistry, Cleanroom, Consulting, Content Development, Current Good Manufacturing Practice (cGMP), Data Quality, Environmental Health, Equipment Validation, FDA (Food and Drug Administration), GLP (Good Laboratory Practices), Housekeeping/Cleaning, ISO (International Organization for Standardization), Identify Issues, Laboratory, Laboratory Equipment, Manufacturing, Materials Analysis, Mathematics, Medical Equipment, Messaging Technology, Microsoft Office, Needs Assessment, Problem Solving Skills, Purchasing/Procurement, Regulations, Safety Compliance, Safety/Work Safety, Short Messaging Service (SMS), Speech Technology, Standard Operating Procedures (SOP), State Laws and Regulations, Telephony, Time Management, Training Program, Validation Plan
LOCATION
Madison, WI
POSTED
4 days ago
Payrate: $29.81 - $29.81/hr.
 
Summary:
The role involves organizing and presenting in-person training sessions on SOPs, cGMP processes, compliance, and Environmental Health and Safety to the cGMP BioManufacturing Group. The specialist will assist in developing content, formatting training materials, and administering training programs to enhance skills, safety, and knowledge.
 
Responsibilities:
  • Track and monitor training, providing timely and accurate reports to the Training Manager.
  • Actively lead training sessions and assist in conducting needs assessments.
  • Collaborate with managers to address learning issues and new educational needs.
  • Assist in developing qualifications and evaluations to ensure training effectiveness.
  • Design and develop training on job-specific tasks, SOP training, FDA cGMP, and safety regulations.
  • Revise training materials based on assessment findings.
  • Partner with Subject Matter Experts to identify needs and desired performance standards.
  • Provide on-the-floor manufacturing support and assist with SOP training as needed.
  • Participate in team meetings and track training records for accuracy.
  • Maintain the effectiveness of the Quality system related to cGMP and training requirements.
  • Assist in cleanroom housekeeping and adherence to 5S standards.
  • Execute equipment qualification/validation protocols as required.
  • Perform other duties as assigned.
 
Qualifications:
  • B.S./B.A. in Biology, Chemistry, or a related scientific field.
  • Minimum of 1-2 years of experience in related laboratory work.
 
Skills:
  • Experience in BioManufacturing or Pharmaceutical/Medical Device industries.
  • Knowledge of clean room, aseptic techniques, and general lab equipment.
  • Familiarity with cGMP, GDP, and GLP practices.
  • Experience with standard operating procedures and equipment troubleshooting.
  • Prior experience with ISO 6/7/8 cleanroom environments and dedicated training.
  • Proficiency in electronic tracking software like Trackwise or ComplianceWire.
  • Ability to work in ISO 6/7/8 cleanroom environments and use MS Office applications.
  • Strong mathematical skills for data accuracy and peer reviews.
  • Independent application of cGMPs in documentation and equipment use.
 
Pay Transparency: The typical base pay for this role across the U.S. is: $29.81 - $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, dental, and vision 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.
 
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About the Company

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Aditi Consulting