Job Opportunities

DO YOU HAVE AN EXPERTISE WE ARE LOOKING FOR?

CELLSCRIPT™, a biotech and biotherapeutics company in Madison, Wisconsin focused on RNA for clinical research and therapeutic applications, seeks experienced individuals with knowledge, skills and proven accomplishments to join the company in the following areas:

QA ASSOCIATE, QUALITY ASSURANCE

Responsibilities:

  • Maintain quality assurance standards, processes, and controls.
  • Assist with writing, revising, approving and archival of standard operating procedures (SOPs), master specifications, and production batch record.
  • Review and approve SOP, protocols and reports used to support manufacture of therapeutic products, following Good Manufacturing Practice guidelines.
  • Review records for raw materials, solutions, equipment, stability, intermediate products and finished products.
  • Assist investigations and resolve potential product quality issues. Perform review and approval of OOS, deviations, CAPAs, complaints, nonconformance, and investigations as required.
  • Ensure systems are in compliance with current SOPs.
  • Generate, publish, and manage quality systems metrics to drive continuous improvement.
  • Perform internal and external audits as assigned.
  • Coordinate and/or conduct GMP training.
  • Supports the commissioning and qualification of new equipment, instruments, including computer systems.
  • Maintains and enhances validation programs for existing equipment, utility commissioning and qualification, and computer systems.
  • Assists in the development of a process validation program.
  • May perform additional duties as required.

Requirements:

  • At least 2 years’ experience in cGMP or other regulated environment within relevant Quality Assurance/Compliance functions. Be able to make data driven decisions that support compliance and site quality system.
  • Functional understanding and experience with aseptic processing and the technologies used to support it including sterility assurance, environmental monitoring, contamination control and facility design and layout (classification schemes).
  • Use critical thinking skills to bring solutions to quality and technical topics such as audits, reviews investigations, root cause analysis, and risk management tools.
  • Excellent writing and communication skills and experience with use of computers and software.
  • Knowledge and experience with MasterControl™ or similar software would be a plus.
  • The Quality Specialist will mainly work in an office environment but will also be required to work in ISO 7 or ISO 8 manufacturing and QC environments when providing QA support in those functional areas.

Education:

  • Bachelors’ degree in a scientific discipline or the equivalent combination of education and experience.

For consideration, email cover letter and resume to hr@cellscript.com.


CELLSCRIPT™ is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, age, gender identity, veteran status, marital status, and any other status protected by applicable local, state, or federal law.


Benefits include:

  • Health insurance
  • Dental insurance
  • Vision insurance
  • Flexible spending account
  • 401(k)
  • LTD, Life & AD&D Insurance
  • Paid time off
  • Company paid holidays
  • Employee assistance program