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QC Coordinator (Chemistry)

Company: Kelly Services
Location: Northampton
Posted on: April 9, 2021

Job Description:

QA/QC Coordinator (Pharmaceuticals)Allentown, PADirect-Hire OpportunityShifts Available:

  • Monday-Friday, 2:30PM-11PM (more QA focused)
  • Monday-Friday, 10AM-6:30PM (more QC focused)
  • Sunday-Thursday, 9AM-5:30PM (more QC focused)Kelly Science & Clinical is interviewing and hiring immediately for a Quality Control Coordinator in Allentown, PA. This position would be responsible for ensuring and assisting with quality compliance, review of documents, label control, release activities, and product inspections. This is a great fit for someone with previous quality/manufacturing experience looking to grow long-term with a great team offering competitive benefits.Responsibilities:
    • Perform and review the Daily Compliance Verification Checklist, document results, and report to immediate supervisor.
    • Perform and/or coordinate completion of:
    • Environmental monitoring and documentation e.g. personnel monitoring, air bioburden, surface bioburden, temperatures, and particle counts
    • Collect Environmental Monitoring samples as necessary
    • New staff training
    • Sterility tests, aseptic technique qualifications, and media fill process validations.
    • Perform Document review of anticipatory and as appropriate non-sterile to sterile compounding batch records:
    • Verify that raw materials meet specification limits
    • Verify accuracy of labeling
    • Perform final disposition of Batch
    • Verify that product test results meet specification limits
    • Verify that all documentation is complete
    • Document non-compliance and evaluate if further investigation is needed
    • Submit samples to the appropriate labs for chemical assay and microbial tests.
    • Track vendor equipment calibration and maintenance records and assess for deviations.
    • Enter test results or summaries into the pharmacy specific monthly and quarterly Quality Assurance report template.
    • Under the direction of supervisor, document results of deviation and complaint investigations, causal analysis, corrective actions, and preventive actions
    • Support Internal & External audits.
    • Maintain quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification etc.).
    • Participate in Director of Pharmacy's staff meetings
      • As assigned by immediate supervisor.--QualificationsRequired:
        • B.S. or B.A. degree in Science (Biology, Microbiology, Chemistry, Pharmacy)
        • Previous experience in a QC/QC department of a pharmaceutical or Allied Health Science.
        • As assigned by Supervisor.Desired:
          • Minimum of 2 years' experience in pharmacy preparation.
          • Pharmacy Technician Certification.
          • Experience with HPLC, UPLC, ICP, and titrations
          • Experience with sample preparation
          • Experience writing/revising/editing SOPs--Expertise: Knowledge & Skills
            • Knowledge of pharmacy operations and regulatory guidelines.
            • Ability to perform pharmacy calculations.----
            • Responsibilities: Other DutiesWhy Kelly--?Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly--At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]]

Keywords: Kelly Services, Allentown , QC Coordinator (Chemistry), Other , Northampton, Pennsylvania

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