Quality Specialist - GMP

Contract: Elkhorn, Nebraska, US

Salary: $39.00 Per Hour

Job Code: 356092

End Date: 2024-12-19

Days Left: 23 days, 12 hours left

About the Role:

  • We are seeking a Quality Assurance Specialist to support Manufacturing Operations and serve as the primary Quality Assurance for the PS&S (Packaging Simplification and Sustainability) Initiative at our Elkhorn, NE Site.

Responsibilities:

  • Provide quality compliance guidance to the PS&S team
  • Manage quality systems, Deviation Management, and Change Controls for the Packaging Initiative 
  • Spend time within the department to evaluate compliance and build relationships with production operators and management
  • Assist with packaging-related quality questions and inquiries - Update and review SOPs related to the Packaging department
  • Undertake short-term tasks and projects with varying degrees of urgency and difficulty 
  • Participate in Quality Compliance Inspections from off-site entities
  • Support other short-term projects and site initiatives as needed

Education Qualification:

  • High School with at least 3 years of relevant experience OR
  • Associates Degree/Bachelor's degree/Master's degree with 1+ year of relevant experience in a regulated industry

Required Skills:

  • Minimum of 2 years of Quality experience in a regulated industry
  • Strong written and verbal communication skills
  • Experience with investigations, risk assessment, and regulatory inspections - Technical writing skills
  • Experience with QMS like SAP, Trackwise, or similar quality systems Preferred

Experience and Skills:

  • Familiarity/experience with vaccine manufacturing and packaging
  • Knowledge of USDA regulations and inspections
  • Project Management experience Note:
  • This is an onsite role that requires someone with experience in a regulated industry (FDA/USDA), GMP industry (Pharma/Vaccine manufacturing/Animal health products or Medical device), change control expertise, and QMS proficiency (Trackwise, SAP).
Job Requirement
  • Quality Specialist
  • GMP
  • cGMP
  • QMS
  • SAP
  • FDA
  • USDA
  • vaccine
  • vaccine manufacturing
  • investigations
  • regulatory
  • regulatory inspections
  • risk assessment
  • Technical writing
  • SOPs
  • Deviation Management
  • Change Controls
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Rohan Lazarus
  • rohan.lazarus@collabera.com
Apply Now
Apply Now
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Collabera is a leading global digital talent solutions firm. For over 25 years, we have provided digital and IT talent services, direct placement and career advisement, global remote talent and learning solutions to transform and diversify workforces for the Fortune 1000 globally.

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