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Quality Assurance Quality Control (QA-QC) Inspector IV

Company: Kelly Services
Location: Worcester
Posted on: April 10, 2021

Job Description:

Kelly is hiring a--Quality Assurance Quality Control (QA-QC) Inspector IV--for one of our biotechnology clients in Worcester, MA

  • Minimum 1 year contract
  • Pay: Negotiable--What are the top 3-5 skills requirements should this person have?1. Experience authoring on INDs/ IMPDs or BLA2. GMP investigation support and Root cause analysis3. Trend Analysis4. Technical proficiency that enables effective management of QC process.5. High level professional written and oral communication skills.The (Quality Assurance Quality Control (QA-QC) Inspector IV) will be tasked to technical support to cross-functional teams within and outside of QC for a given API or drug product. Accountable for QC CMC support for regulatory filings, trend analysis and investigation support in QC while maintaining and meeting the highest standards in quality, customer service and regulatory compliance.Responsibilities:--- Responsible for authoring and review of regulatory filings (INDs/ IMPDs/ BLA and DSUR).--- Responsible for providing Investigation support and lead the root case analysis.--- Exception Request (ER) and CAPA management.--- Perform Stability trend analysis.--- Delivery of files samples.--- Filing of GMP documentation.Qualifications:--- 8+ years of direct experience in biopharmaceutical or related industry is required.--- Thorough knowledge of Quality Assurance operations.--- 6+ years of experience in application of FDA/GMP regulations.--- Strong communication skills, tact, and diplomacy are critical.--- Must be effective in multidisciplinary teams and work effectively across the organization.--- Direct regulatory interface experience is preferred.Why 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, Worcester , Quality Assurance Quality Control (QA-QC) Inspector IV, Other , Worcester, Massachusetts

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