Talent.com
Quality Control Analyst
Quality Control AnalystInsight Global • Malvern, PA, US
Quality Control Analyst

Quality Control Analyst

Insight Global • Malvern, PA, US
1 day ago
Job type
  • Part-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, US

    Related jobs
    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: 30+ days ago • Promoted
    Board Certified Behavior Analyst

    Board Certified Behavior Analyst

    Pediatric Therapeutic Services, Inc. • Oley, PA, US
    Full-time
    Pediatric Therapeutic Services (PTS) is seeking a full time Board-Certified Behavior Analyst (BCBA) to provide school-based services to a local school district in Oley, PA.We offer competitive rate...Show more
    Last updated: 29 days ago • Promoted
    Quality Control Area Engineer - Track and Systems

    Quality Control Area Engineer - Track and Systems

    Sheladia Associates • North East, MD, United States
    Full-time
    This position is posted to source for current / future opportunities - we are eager to connect with talented professionals seeking their next role. We will contact you with status of current / expected ...Show more
    Last updated: 30+ 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
    Senior Analyst II, Quality Control

    Senior Analyst II, Quality Control

    Resilience • East Norriton, PA, United States
    Full-time
    A career at Resilience is more than just a job - it's an opportunity to change the future.Resilience is a technology-focused biomanufacturing company that's. We're building a sustainable network of ...Show more
    Last updated: 5 days ago • Promoted
    Quality Control Tech - 10PM

    Quality Control Tech - 10PM

    The High Companies • Denver, PA, United States
    Full-time
    With more than 75 years of experience and nearly five decades as a precast leader, we’ve become a trusted partner for architects, engineers, and builders nationwide. As the nation’s largest producer...Show more
    Last updated: 29 days ago • Promoted
    Quality Control Lead Inspector

    Quality Control Lead Inspector

    Jobot • Montgomeryville, Pennsylvania, US
    Full-time +1
    Lead Quality Inspections & Drive Precision Manufacturing Excellence – Join Our Day-Shift Team!.Before applying for this role, please read the following information about this opportunity found ...Show more
    Last updated: 12 days ago • Promoted
    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 Assurance Analyst

    Quality Assurance Analyst

    BrightView Landscapes • Blue Bell, PA, US
    Full-time
    The Best Teams are Created and Maintained Here.At BrightView, the best teams are created and maintained here.If you are searching for your next fulfilling career, picture yourself on a best-in-clas...Show more
    Last updated: 18 days ago
    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: 30+ days ago
    Quality Systems Document Analyst 2

    Quality Systems Document Analyst 2

    eTeam Inc • Fort Washington, Pennsylvania, United States
    Temporary
    Quick Apply
    Job Title : Quality Systems Document Analyst 2.Job Type : Contract; 12 months contract.Location : Fort Washington, PA 19034. The QA Specialist is responsible for providing daily Quality Assurance suppo...Show more
    Last updated: 30+ days ago
    Quality Control Analyst

    Quality Control Analyst

    Insight Global • Malvern, PA, United States
    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: 18 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: 20 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
    Board Certified Behavior Analyst (BCBA)

    Board Certified Behavior Analyst (BCBA)

    Pediatric Therapeutic Services, Inc. • Atglen, PA, US
    Full-time
    Pediatric Therapeutic Services (PTS) is seeking a full time Board-Certified Behavior Analyst (BCBA) to provide school-based services to a local school district in Atglen, PA.We offer competitive ra...Show more
    Last updated: 30+ days ago • Promoted
    Production Control Analyst

    Production Control Analyst

    Giorgio Foods • Blandon, PA, United States
    Full-time
    Production Control Analyst to work at our Blandon, PA location.This individual will be on-site creating and maintaining production schedules in order to ensure that all company goals are achieved a...Show more
    Last updated: 1 day ago • Promoted