Analytical Cleaning Validation Specialist

2 weeks ago


Bangor, Maine, United States BioSpectra Full time
Job Title: Analytical Cleaning Validation Specialist

The Analytical Cleaning Validation Specialist is a key member of the BioSpectra team, responsible for ensuring the highest standards of cleaning validation and environmental monitoring in our facilities.

Key Responsibilities:
  • Develop and execute cleaning validation protocols, including risk assessments, process and procedure development, and sample collection and analysis.
  • Collaborate with cross-functional teams to ensure compliance with regulatory standards, internal master plans, and procedures.
  • Perform environmental monitoring sampling, including departmental schedule coordination and requesting CAPA activities as needed.
  • Support method validations, including specific and non-specific analytical methods, extraction studies, and recovery studies.
  • Conduct statistical analysis of data and summarize results in final reports.
  • Review technical and quality system documents, including SOPs, Change Control, and Deviation Reports.
Requirements:
  • Four-year degree in Science, Engineering, or related field.
  • Minimum 3 years of experience in a cGMP Laboratory with knowledge of current best practices.
  • Knowledge and understanding of cGMP & ICH Q7.
  • Excellent analytical skills with systematic approaches to problem-solving.
  • Ability to communicate effectively at all levels in verbal and written form.
  • Organized, thorough, and neat.
  • Must be able to read, write, speak, and understand English.
Physical Requirements:
  • Lift up to 15 lbs. occasionally.
  • Prolonged periods sitting at a desk and working on a computer.
  • Ability to see and distinguish color.
  • Bend, stoop, and carry.
  • Repeating motion that may include wrists, hands, and fingers.
Work Hours:
  • Exempt Position.
  • Minimum of 40-45 Hours Week, or other agreed-upon documented schedule.
  • Ability and willingness to work from all BioSpectra facilities.


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