QC Environmental Monitoring Associate

1 month ago

Philadelphia, United States Beacon Hill Pharma Full time
Job DescriptionJob Description

Key Responsibilities:

  • Conduct viable and non-viable environmental monitoring to support Manufacturing and Quality Control, including air, surface, personnel, and particulate testing within clean rooms.
  • Verify batch records for critical processing steps during aseptic product manufacturing to ensure accuracy and compliance.
  • Perform Growth Promotion testing on prepared media.
  • Oversee and conduct Sterile Media Fill Trials and related support testing.
  • Maintain cleanliness and organization in Quality Control laboratories.
  • Assist the Quality Control department with daily operations as needed.
  • Author and update Quality Control SOPs to maintain regulatory compliance.
  • Respond promptly to Out of Specification (OOS) results, notifying supervisors and taking appropriate action.
  • Collaborate with Manufacturing, Quality Assurance, and Facilities departments to meet company objectives and timelines.
  • Utilize various analytical equipment to support product quality assessments.
  • Train other employees as required on environmental monitoring procedures.
  • Prepare thorough Manufacturing Investigation Reports (MIRs), ensuring that potential issues, root causes, and preventive actions are identified and addressed.

Computer Skills:

  • Proficiency in database management, project management tools, spreadsheets, and word processing software.

Education:

  • Bachelor of Science degree in a scientific discipline (minimum).

Experience:

  • Knowledge of Current Good Manufacturing Practices (cGMP) and industry standards.
  • Previous experience in a similar role within the biologics or pharmaceutical industry.
  • Experience with aseptic processing and mammalian cell culture production.
  • Familiarity with basic laboratory equipment such as microscopes, pH meters, and incubators.
  • Strong verbal, written, and organizational skills.
  • Excellent interpersonal and communication abilities.
  • Willingness to work occasional off-shift and weekend hours.

Please Note: This position is located in a Western Suburb of Philadelphia, PA 

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