Openings >> QA Validation Internship (Science/Engineering)
QA Validation Internship (Science/Engineering)
Title:QA Validation Internship (Science/Engineering)
Labor Type:Contract
Posting #:7888062
Location:Madison, WI
Compensation:$15.00 hourly

Job Role:

  • Applies existing validation programs for the commissioning and qualification of new equipment, instruments, including major capital projects and computer systems.
  • Maintains validation programs for existing equipment, utility commissioning and qualification, and computer systems.
  • Drafts, reviews, and executes protocols and reports related to equipment, facility, and computer validation. This includes deviation reporting during execution.
  • Provides statistical support for Quality Systems monitoring and review.
  • Assists in customer / regulatory audits and responding to audit observations and corrective actions.
  • Collaborates significantly with cross functional groups, including Quality, Manufacturing, Process Development, Facilities, and Regulatory Affairs.
  • Files and maintains controlled documents.
  • Other duties as assigned.


Minimum Requirements:

  • Current 3rd or 4th year undergraduate student in technical discipline (e.g. biology, biotechnology, engineering) or related life science program
  • Ability to use Excel, Word, and other office systems
  • Ability to understand and independently apply GMPs to everyday work with regard to documentation and review.
  • Ability to apply applicable regulatory authority and guidelines with training.
  • Demonstrates theoretical understanding of the work tasks assigned.
  • Ability to operate within a clean room environment as needed.
  • Maintain high quality documentation in accordance with applicable regulatory guidance and Site SOPs.
  • Ability to learn and use quality management software (e.g. TrackWise(R), ComplianceWire(R)).
  • Ability to learn and retain technical information.
  • Executes routine procedures and process with high quality.
  • Ability to operate assigned office equipment.
  • Ability to complete investigation, deviation, and change control forms with initial consultation from supervisor as needed
  • Capable of learning of unfamiliar principles or techniques with training.
  • Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Edits Standard Operating Procedures (SOPs), Batch Production Records (BPRs), and reports independently and accurately.


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