US - Quality Control Expert

Company: Experis
Location: Rocklin
Posted on: May 10, 2022

Job Description:

Greetings,Experis, a Manpower Group company has an exciting contract opportunity for Quality Control Specialist at Rocklin, CA 95677. This position is 12+ months contract for one of our key Pharmaceutical clients, offers chemicals for applications in laboratories and industry.Job Details:Industry: PharmaceuticalRole: Quality Control SpecialistLocation: Rocklin, CA 95677 - 100% OnsiteDuration: 12+ months contract (contract to hire)Schedule: M/F : 8:00am - 5:00pmDescription:

• Under moderate supervision, the Stability Analyst will be part of the Quality team and responsible for performing stability testing of IVD and ASR products according to SOPs and in compliance with local and global QMS and regulatory requirements.
• Support the day-to-day activities of the Quality department while adhering to applicable regulatory requirements, ISO 13485, local and global QMS. Required Skills:
  • Testing on instrumentation
  • Working in a lab
  • Performing Assays
  • Recent Grads - willing to trainDuties and Responsibilities:
    • Perform stability testing of IVD and ASR products according to SOPs and in compliance with local and global QMS and regulatory requirements.
    • Record and document testing results accurately and per applicable regulatory and SOP requirements.
    • Data analysis using Microsoft Excel.
    • Maintain extensive knowledge of Standard Operating Procedures and GMP regulations and guidelines.
    • Troubleshoot equipment problems.
    • Recognize atypical and out of specification results, instrument malfunctions, and methodology issues and participate in the investigation process.
    • Maintain cGMP compliance in the laboratory.Additional Responsibilities:
      • Maintain and demonstrate a high level of personal and professional integrity and report any suspicious activity to laboratory management
      • Must be willing and able to work on weekends or extended hours as neededEducation & Experience:
        • S. degree in a biological science or equivalent life sciences degree preferred, or equivalent combination of education and experience
        • Experience in medical device, drug, and/or biologics
        • General knowledge of FDA QSRs cGMP, and ISO 13485 or other related industry standardsKnowledge / Skills & Abilities:
          • Knowledge & experience in ELISA, bioburden and IHC testing
          • Ability to work independently and manage multiple analyses
          • Knowledge of cGMPs related to QC operations
          • Experience working in ISO 13485 and/or FDA regulated laboratory
          • Experience in SAP and/or SAP NEXT
          • Good computer skills, PC including MS Excel
          • Excellent written and verbal skillsApply Today!

Keywords: Experis, Rocklin , US - Quality Control Expert, Other , Rocklin, California