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1st Shift CGMP Biomanufactuirng Training Specialist

The Fountain Group LLC

Madison, WI

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JOB DETAILS
SALARY
SKILLS
Asepsis, Biology, Biotech and Pharmaceutical, Chemistry, Cleanroom, Current Good Manufacturing Practice (cGMP), Documentation, Environmental Health, Equipment Maintenance/Repair, Equipment Validation, GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Identify Issues, Maintain Compliance, Manufacturing, Manufacturing Operations, Manufacturing/Industrial Processes, Medical Equipment, Metrics, Microsoft Excel, Program Evaluation, Quality Assurance, Safety Compliance, Safety/Work Safety, Standard Operating Procedures (SOP), Training Program, Training/Teaching, Training/Teaching Curriculum
LOCATION
Madison, WI
POSTED
5 days ago

The Fountain Group is currently seeking a Training Specialist – cGMP Biomanufacturing for a prominent client of ours. This position is located at Madison,WI. Details for the position are as follows:

Training Specialist – cGMP Biomanufacturing
Location: Onsite
Pay Rate: $29.81/hr
Duration: 6 Months
Schedule: Monday–Friday, 8:00 AM–5:00 PM

Job Description

Support the cGMP Biomanufacturing training program by organizing and delivering instructor-led training on SOPs, cGMP compliance, Environmental Health & Safety, and manufacturing processes. Assist in the development, administration, and tracking of training programs to ensure regulatory compliance and workforce qualification.

Key responsibilities include:

  • Deliver in-person training for manufacturing personnel on SOPs, cGMP requirements, and EHS procedures
  • Develop, format, and revise training materials, qualification programs, and assessments
  • Track training completion, compliance metrics, and training records
  • Support training effectiveness evaluations and qualification programs
  • Collaborate with Quality Assurance on SOP training initiatives
  • Maintain training documentation in compliance with cGMP, GDP, and GLP requirements
  • Provide on-floor manufacturing support within cleanroom environments
  • Assist with equipment qualification and validation activities
  • Support adherence to ISO 6/7/8 cleanroom standards and 5S practices

Education

  • Bachelor's degree in Biology, Chemistry, Biotechnology, Life Sciences, or related scientific discipline
  • Minimum 1 year of experience in a regulated biotechnology, pharmaceutical, medical device, or laboratory environment

Required Skills

  • cGMP, GLP, and Good Documentation Practices (GDP)
  • Cleanroom operations within ISO 6/7/8 environments
  • Aseptic processing and sterile technique
  • Biomanufacturing equipment operation, maintenance, and troubleshooting
  • SOP training and compliance documentation
  • Training record management and compliance tracking
  • Equipment qualification and validation support
  • Manufacturing floor support in regulated environments
  • Electronic training management systems
  • Microsoft Excel and documentation systems

Preferred Skills

  • Commercial biomanufacturing experience
  • Development of training curricula, assessments, and qualification programs
  • Instructor-led manufacturing or compliance training
  • TrackWise, ComplianceWire, or similar electronic quality/training systems
  • Quality Assurance training support
  • Environmental Health & Safety (EHS) training
  • Process training within GMP manufacturing operations
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About the Company

T

The Fountain Group LLC

The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
WEBSITE
https://www.thefountaingroup.com/