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Scientific. Clinical. Software Engineering

Compliance Specialist

Allentown-Bethlehem-Easton Area, PA

Job Type: Scientific Job Number: JN -042019-24479 Region: Allentown-Bethlehem-Easton Area

Job Description

  • Working knowledge of chemical and microbiological test methods.
  • Working knowledge of various validation.
  • Comprehensive process understanding.
  • Identify process monitoring excursions per the documented control criteria.
  • Work with cross-functional teams to investigate amd author process monitorimg excursions.
  • Back-up to lead process monitoring weekly meetings with cross functiomal team. Maintain a communication pathway with the Antigen Leadership Group on process robustness and excursions.
  • Basic statistics working knowledge and basic programming (JMP, SAS).
  • Proficient Technical Writer, Project Management, Root Cause Analysis. Abiliity to interpret trends in data relative to process performance to drive more robust performance.
  • Verbal and written communication skills.
  • Adherence to commitment dates.
  • Desire to work in fast-paced environment.
  • Customer focused, results driven, Shop floor oriented.
  • Self motivated.
  • Demonstrated ability to be successful as a Leader of a diverse cross functional team.
  • Detailed knowledge of cGMPs.
  • 2+ Years Industry experience
  • Working knowledge of chemical and microbiological test methods
  • Working knowledge of various validations
  • Comprehensive process understanding
  • Successful candidate has a minimum of a 4 yr degree (Biology / chemistry / engineering / statistics)
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