Quality Control Specialist

  • location: Rockville, MD
  • type: Contract
  • salary: $21.56 - $25.36 per hour
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job description

Quality Control Specialist

job summary:
  • The analytical support specialist supports the operation and performance of key business information systems critical to the Quality Control Organization.
  • Supports delivery of strategic IT programs to Quality Control Organization.
  • Works with key business personnel at the site as well as above site support in implementing programs that align with the needs and efforts of the Quality Control Organization.
  • This includes business needs assessments, risk and priority assignment, and project justification and approval skills and experience.
 
location: Rockville, Maryland
job type: Contract
salary: $21.56 - 25.36 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Serve as system administrator on laboratory systems to identify, analyze, and troubleshoot problems.
  • Assist with development of system administration process
  • Deliver user, process, and technical specifications and design documents.
  • Assess laboratory systems for regulatory compliance requirements.
  • Implement solutions to ensure laboratory systems compliance
  • Develop and report key usage and performance metrics for systems.
  • Provide user training and support.
  • Manage efforts throughout the life-cycle of laboratory equipment. From planning thru decommissioning.
  • Assist with development of laboratory system life-cycle management process
  • Author, revise, and review SOPs as necessary.
 
qualifications:
  • Minimum Level of Education* BS degree in scientific discipline
  • Laboratory system experience and general GMP
  • Preferred Level of Education BS/ MS
  • 3-5 years experience managing information systems in a GxP regulated environment
  • Strong interpersonal and leadership skills. Solid team player able to function within a team based organization.
  • Strong verbal and written communication skills.
  • Able to interact with peers and senior personnel in a multidisciplinary environment including validation, production and IT
  • Ability to prioritize and decide appropriate course of actions. Effective at implementing decisions and multi-tasking.
  • Fully versed in GMP's, NIH, ICH Guidelines, FDA and other regulatory agency requirements for validation and operations of analytical and stability functions.
 
skills: Quality control, SOP, ICH Regulations, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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    Specialist

  • location: Rockville, MD
  • job type: Contract
  • salary: $21 - $30.05 per hour
  • date posted: 12/7/2018