Talent.com
Quality Control Analyst
Quality Control AnalystInsight Global • Malvern, PA, United States
No longer accepting applications
Quality Control Analyst

Quality Control Analyst

Insight Global • Malvern, PA, United States
1 day ago
Job type
  • Full-time
Job description

Compensation & Details :

  • 2 Openings
  • Fully onsite role in Malvern, PA - in the laboratory
  • $35-39 / hr - exact rate is based on several factors, including skills, experience, and education.
  • Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and / or other paid time off as provided by applicable law
  • 10 PTO Days & 6 Sick Days
  • 12 month extending contract

Requirements :

  • Minimum two (2) years of relevant work experience
  • Experience in Medical Device, Biopharmaceutical, or Pharmaceutical industry
  • Working experience in a current Good Manufacturing Practices (cGMP) compliant QC laboratory or equivalent environment and solid understanding of cGMP and current Good Laboratory Practices (GLPs)
  • Must have experience in the following : qPCR, cell culture, Flow Cytometry, and / or ELISA
  • Ability to read / interpret technical documents such as SOPs, work instructions, test methods and protocols
  • Proficient with Microsoft Office applications (Outlook, One Note, Teams, Excel, Word, and PowerPoint)
  • Day to Day : The QC CRS Analyst is responsible for conducting biochemical and testing of drug substance, final product release and characterization samples, and critical reagent qualifications of cell and gene therapy products, including CAR-T. They are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations. They typically work with a team of 10 – 15 other Analysts within a functional Clinical Release and Stability (CRS) Laboratory and report to one of two QC CRS Supervisors. Key Responsibilities :

  • Conduct analytical biological testing (ELISAs, qPCR, Flow Cytometry, Cell-based assays, etc.) of clinical and commercial drug product / drug substance samples
  • Perform peer reviews and approvals of laboratory data
  • Use electronic systems (LIMS, MES, Empower, etc.) for execution and documentation of laboratory data
  • Support of New Product Initiatives (NPI) in groups of 3-6 analysts
  • Perform Instrument Calibration and / or Preventative Maintenance, as needed
  • Update CRS-owned documents using the Electronic Document Management System (EDMS)
  • Order / receive supplies and manage inventory
  • Support analytical method qualification, validation, and transfer into and out of the QC lab, owning change control actions, completing testing activities with mentorship from Sr. Analysts on transfer activities
  • Complete change control processes to integrate new methodologies and technologies into and out of the CRS Lab with limited oversight
  • Complete invalid assay and general laboratory investigation records
  • Complete corrective and preventative actions (CAPA) as assigned
  • Assist in the execution of internal audits
  • Create a job alert for this search

    Quality Control Analyst • Malvern, PA, United States

    Related jobs
    Quality Control Analyst

    Quality Control Analyst

    Insight Global • Malvern, PA, US
    Full-time
    Fully onsite role in Malvern, PA - in the laboratory.HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid ...Show more
    Last updated: 30+ days ago • Promoted
    Models Mission Control, Analyst

    Models Mission Control, Analyst

    Chatham Financial • Kennett Square, PA, United States
    Full-time
    We don't simply hire employees.When you work at Chatham, we empower you - offering professional development opportunities to help you grow in your career, no matter if you've been here for five mon...Show more
    Last updated: 15 days ago • Promoted
    Quality Assurance Compliance Analyst

    Quality Assurance Compliance Analyst

    VirtualVocations • Newark, Delaware, United States
    Full-time
    A company is looking for a Quality Assurance & Compliance Analyst.Key Responsibilities Conduct regular audits of case files, billing, and service delivery for compliance with Medicaid waiver and ...Show more
    Last updated: 1 day ago • Promoted
    Quality Control Supervisor

    Quality Control Supervisor

    Globus Medical • Eagleville, PA, US
    Full-time
    Branch Medical Group, a subsidiary of Globus Medical Inc.Our passion, combined with Globus' world-class engineering, transforms clinical insights into tangible musculoskeletal solutions.We are cons...Show more
    Last updated: 7 days ago • Promoted
    Analyst 2, Quality Assurance

    Analyst 2, Quality Assurance

    eTeam Inc • Fort Washington, Pennsylvania, United States
    Temporary
    Quick Apply
    Job Title : Analyst 2, Quality Assurance.Type : Contract; 12 Months contract.Location : Fort Washington, PA 19034.The Quality Specialist is responsible to provide Quality Assurance support to the Qual...Show more
    Last updated: 30+ days ago
    Project Controls Analyst

    Project Controls Analyst

    Pyrovio • Reading, PA, US
    Full-time
    The Project Controls Analyst supports client Project Managers by providing a high confidence interval analysis on matters of cost and schedule, supported by earned value methodology.This remote rol...Show more
    Last updated: 30+ days ago • Promoted
    Quality Control Core 3

    Quality Control Core 3

    Careers Integrated Resources Inc • Reading, PA, US
    Full-time
    Job Title : Quality Control Core 3.Job Location : Sinking Spring, PA.Job Duration : 12 Months+ (Possibility of Extension). Shift : Work shift Monday to Friday –.Show more
    Last updated: 24 days ago • Promoted
    Quality Control Supervisor

    Quality Control Supervisor

    IntePros • Conshohocken, PA, US
    Full-time
    IntePros is currently looking for a.This position coordinates and performs quality control processes; executes sound quality policies to ensure safety and quality of products; and performs other re...Show more
    Last updated: 8 days ago • Promoted
    Quality Control Administrator

    Quality Control Administrator

    Applied Energy Systems, Inc. • Malvern, PA, USA
    Full-time
    Quick Apply
    Focuses on the administrative and reporting aspects of the company's quality assurance program, including managing records, analyzing data, and dispositioning quality issues under supervision.Is al...Show more
    Last updated: 17 days ago
    Quality Control Analyst

    Quality Control Analyst

    VirtualVocations • Newark, Delaware, United States
    Full-time
    A company is looking for a Quality Control Analyst - Valuations.Key Responsibilities Perform quality control analysis of valuation reports to ensure compliance with regulatory and client standard...Show more
    Last updated: 30+ days ago • Promoted
    Quality Review and Audit Analyst

    Quality Review and Audit Analyst

    VirtualVocations • Newark, Delaware, United States
    Full-time
    A company is looking for an Individual & Family Plans (IFP) Quality Review and Audit Analyst.Key Responsibilities Conduct medical records reviews and ensure accurate diagnosis code abstraction U...Show more
    Last updated: 30+ days ago • Promoted
    Quality Control Manager

    Quality Control Manager

    Michael Page • West Chester, PA, US
    Full-time
    Join a high-performing team in a cutting-edge CNC machining environment.Enjoy top-tier 100% employer paid benefits.My client is a respected manufacturer of precision-engineered components for the m...Show more
    Last updated: 2 days ago • Promoted
    Analyst 2, Quality Assurance

    Analyst 2, Quality Assurance

    Sunrise Systems • Fort Washington, Pennsylvania, United States
    Full-time
    Quick Apply
    The position is responsible for providing daily Quality Assurance support to the manufacturing site to ensure internal and regulatory cGMP and CFR requirements are met. Quality Assurance support are...Show more
    Last updated: 30+ days ago
    Quality Control Associate

    Quality Control Associate

    Pharmaron • Exton, PA, USA
    Full-time
    Quick Apply
    The expected salary range is $45,000-$50,000 per year.Unfortunately, we cannot support work visa permit applications for this role. Are you ready to embark on an exhilarating journey with a team tha...Show more
    Last updated: 30+ days ago
    Program Cost Scheduling Control Analyst

    Program Cost Scheduling Control Analyst

    Clearance Jobs • Elkton, MD, US
    Full-time
    Program Cost Scheduling Control Analyst.Our aerospace client is looking for a Program Cost Scheduling Control Analyst who will be setting up cost control systems, monitoring and controlling costs a...Show more
    Last updated: 27 days ago • Promoted
    Document Control Analyst 2

    Document Control Analyst 2

    Hologic • Newark, DE, US
    Full-time
    Hologic empowers people to live healthier lives everywhere, every day.We are the leading Innovator in women's health, helping healthcare professionals around the world diagnose and treat their pati...Show more
    Last updated: 30+ days ago • Promoted
    Quality Control Manager

    Quality Control Manager

    Wohlsen Construction • Wilmington, DE, US
    Part-time
    Wohlsen Construction is seeking a highly skilled and certified Quality Control Manager (QCM) for a pivotal role on our Amtrak project. This part-time position will be responsible for overseeing and ...Show more
    Last updated: 30+ days ago • Promoted
    Quality Control Coordinator

    Quality Control Coordinator

    AkzoNobel • Reading, PA, US
    Full-time
    Since 1792, we've been supplying the innovative paints and coatings that help to color people's lives and protect what matters most. Our world class portfolio of brands - including Dulux, In...Show more
    Last updated: 2 days ago • Promoted
    Quality Assurance Statistical Process Control Specialist

    Quality Assurance Statistical Process Control Specialist

    Joulé • Souderton, PA, US
    Full-time
    Job Title : Quality Assurance Specialist, Change Management Location : Souderton, PA Hours / Schedule : M–F, 8 : 00 AM – 5 : 00 PM (First Shift) Compensation : $65,000-$78,000 annually Type : Contract-to-Hire...Show more
    Last updated: 14 days ago • Promoted
    Quality Control Lead Inspector

    Quality Control Lead Inspector

    Jobot • Montgomeryville, PA, US
    Full-time +1
    Lead Quality Inspections & Drive Precision Manufacturing Excellence – Join Our Day-Shift Team!.This Jobot Job is hosted by : Eric Kee. Are you a fit? Easy Apply now by clicking the "Apply Now" button...Show more
    Last updated: 16 days ago • Promoted