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QRM/Contamination Control Strategy/Cleaning Validation Support image - Rise Careers
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QRM/Contamination Control Strategy/Cleaning Validation Support

Under limited supervision and in accordance with the laws, federal regulations, and applicable state and local policies, procedures and guidelines.

RESPONSIBILITIES:

  • Active participation on Cleaning Validation team meetings to provide input on projects timeline considerations, activities, escalations and status of assigned tasks.
  • Active participation on Contamination Control Strategy team meetings to provide input on activities, escalations and status of assigned tasks.
  • Serve as Subject Matter Expert to lead Quality Risk Management exercises and author risk assessment reports. Responsible for implementation of identified actions.
  • Serve as Subject Matter Expert to develop cleaning validation protocols, reports, executable instructions and implementation of additional data integrity requirements.
  • Participate in the revision of the cleaning and contamination control strategy documentation records related to the manufacturing stages and steps.
  • Lead and/or participate on triage activities to assess change control requirements.
  • Issuance or support on change control generation.
  • Issuance change control and present it in Change Control Board to pursue approval of the change.
  • Review documentation associated to contamination control strategy and cleaning program (cleaning validation master plan, risk assessment, protocols, reports, working instructions, sampling scheme, limit calculations, etc.).
  • Revise SOPs related to cleaning program and contamination control strategy.
  • Lead trainings activities provided to manufacturing operators.
  • Comply with Individual Learning Plan Requirements including qualification modules for Darwin, Trackwise, VEEVA (Quality Docs) among others.
  • Comply with additional tasks requested by superviso

Qualifications:

  • Bachelor’s degree in Life Sciences, Engineering, or a related field.
  • Minimum of 3–5 years of experience in the pharmaceutical or biotechnology industry, preferably in a quality or validation role.
  • Strong knowledge of cGMPs, regulatory guidelines, and industry best practices related to cleaning validation and contamination control.
  • Experience leading QRM exercises and authoring technical documentation.
  • Familiarity with change control processes and documentation systems (e.g., VEEVA, Trackwise).
  • Excellent written and verbal communication skills in English and Spanish.

Preferred Skills:

  • Experience with Environmental Monitoring and Microbial Control Strategies.
  • Proficiency with risk assessment tools such as FMEA.
  • Previous experience working in cross-functional and project-based environments.
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Average salary estimate

$85000 / YEARLY (est.)
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$75000K
$95000K

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EMPLOYMENT TYPE
Full-time, remote
DATE POSTED
April 13, 2025

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