Quality Systems Specialist

  • location: Lenexa, KS
  • type: Temporary
  • salary: $21 per hour
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job description

Quality Systems Specialist

A large life science organization in Lenexa, KS is seeking a Quality Systems Specialist. The organization recently moved to a new system/database, and are in need of someone that has the ability to create new reports, new processes, create metrics, and create their SharePoint site.
Responsibilities:
  • Create Reports from Customer Queries such as SFDC, SAP and Trackwise. These metrics will be used internally and externally to enhance performance of Quality Service Team
  • Create complex Dash Boards for Quality Services Team such as Excel Pivot Tables. This includes mining data and setting up methods to collect the data
  • Build and/or enhance Quality Services sites such as the EVA site, Sharepoint, etc
  • Collects data in partnership with Business partner for the Commercial and Business Areas to monitor, report and improve quality performance from a customer's perspective. Including creation of Customer facing dashboards.
  • Assist CR Applied Quality Service Team with overflow customer inquiries/ assume backup position as needed
  • Is responsible for customer quality and regulatory resolution and follow-up of quality incidents
  • Foster customer intimacy and provide customers with interim updates during extended site investigations including face to face meetings as needed
  • Demonstrate expertise in project management, typically in the form of coordinating complex customer inquiries or investigations across global sites
  • Possess an in-depth knowledge of Merck/ MilliporeSigma???s products and industry applications
  • Good understanding relevant regulatory guidelines (ie. GMP) as it relates to the IVD, Medical Devices, Food, Research Markets, etc.
  • Deliver Quality Services, adopting a consultative approach to understand customer needs, explain our quality systems capabilities and communicate that commitment

Working hours: 8:00 AM - 5:00 PM
Skills:
  • Understanding of basic Quality concepts. Interpersonal skills.
  • Excellent verbal and written communication skills
  • Working knowledge quality regulatory requirement
  • Scientific problem solving skills
  • Biochemistry
  • Chemistry or Life Science knowledge
  • Leadership skills
  • Understanding of basic Quality Assurance concepts
  • Interpersonal skills
  • Excellent verbal and written communication skills
  • Flexible working hours as required to meet global customer deadlines.
  • Ability to work and participate in a team
  • Computer skills
  • Project Management Skills
  • cGMP knowledge
  • Regulatory knowledge as related to SAFC products and the Pharma and BioPharma industry

Qualifications:
  • Masters or Bachelor's degree (chemist, pharmacist, biologist, engineer) with equivalent experience in a relevant scientific-based or quality assurance position.
  • Two to five years scientific-based work or quality/ technical based customer communications.

Preferred Skills:
  • Biochemistry/chemistry knowledge.
  • Protein/viral purification and or quantitation.
  • Industrial/pilot scale cell culture and/or drug manufacturing experience.
  • Working knowledge of FDA and/or USDA regulatory requirements
  • Experience writing protocols and reports
  • Industry GMP experience
  • Investigation Management Experience (Root Cause, Corrective and Preventative Action, Effectiveness Checks)

Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Sexual Orientation, Gender Identity, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.
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