Quality Control Analyst

2 weeks ago


Malvern PA United States Insight Global Full time

Hiring Model: 6 month Extending Contract

5 Days of PTO / Paid Holidays / 3 Sick Days + Full Benefits


Compensation:

$34.75/hr to $46.50/hr.

Exact compensation may vary based on several factors, including skills, experience, and education.

Benefit packages for this role will start on the 31st 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.


Required Skills & Experience


-Minimum one year of relevant GMP work experience in a lab setting

-Bachelor degree in Biology or Chemistry

-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)

-Experience with one or more of the analytical technologies used in the Cell and Gene Therapy Laboratories such as 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


Nice to Have Skills & Experience


-1 year of experience working with mammalian cell culture -CAR-T, Cell and Gene Therapy, or Biochemistry laboratory experience -Basic knowledge of Compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC -Ability to complete equipment and software qualification protocols -Experience developing and setting long-term objectives -Experience working in Biosafety Level lab (BSL 2, BSL2+) or aseptic facility -Knowledge of EU/FDA guidance


Job Description


The QC CRS Analyst is responsible for conducting biochemical and testing of raw material, in-process, final product release and characterization samples, 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 5 -- 10 other Analysts within a functional Clinical Release and Stability Laboratory and report to the Senior QC Supervisor.

Key Responsibilities:

-Conduct analytical biological testing of clinical and commercial drug product/drug substance samples

-Perform peer reviews and approvals of laboratory data

-Use electronic systems (LIMS, MES, LES, Empower, etc.) for execution and documentation of testing including application of statistical concepts to laboratory data

-Support of New Product Initiatives (NPI) including owning a project and perform project management functions with limited to no coaching from supervision/management

-Perform Instrument Calibration and Preventative Maintenance

-Update CRS-owned documents using the Document Management System (DMS)

-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

-Act as a peer subject matter expert in assessing talent by participating in panel interviews for job

-Complete invalid assay and general laboratory investigation records

-Complete corrective and preventative actions (CAPA) as assigned

-Assist in the execution of internal audits



  • Malvern, United States Insight Global Full time

    Job descriptionRequired Skills & Experience-Minimum one year of relevant GMP work experience in a lab setting -Bachelor degree in Biology or Chemistry -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) -Experience...


  • New York, NY, United States Michael Page Full time

    The Quality Control Analyst role is responsible for end-to-end Quality Assurance (QA) review testing over the BSA/AML & Sanctions Program. Additional responsibilities include the remediation review & validation of issues deriving from regulatory, internal audit and self-assessment exams/reviews and the monitoring, tracking and (internal) reporting of...


  • Gaithersburg, MD, United States Diati Staffing Full time

    The Quality Control Senior Analyst is responsible for day to day operations related to release and stability testing, maintaining QC cell culture lines, and writing SOPs, deviations, change controls and CAPAs as part of typical QC operations.Responsibilities include but are not limited toPerforms GMP release and stability testing in Quality ControlWrite...


  • Gaithersburg, MD, United States Diati Staffing Full time

    The Quality Control Senior Analyst is responsible for day to day operations related to release and stability testing, maintaining QC cell culture lines, and writing SOPs, deviations, change controls and CAPAs as part of typical QC operations.Responsibilities include but are not limited to:Performs GMP release and stability testing in Quality ControlWrite...


  • Malvern, United States Insight Global Full time

    Hiring Model: 6 month Extending Contract 5 Days of PTO / Paid Holidays / 3 Sick Days + Full BenefitsCompensation:$34.75/hr to $46.50/hr. Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance,...


  • , GA, United States TDX Quality Full time

    Job Title: Quality Control ManagerSand Point Services, LLC (SPS) is a leading General Contractor that specializes in design-build and general construction, providing a wide range of construction services to government and commercial customers. At SPS, we believe our team members are our greatest asset. We proudly serve our military and other federal clients...


  • Piscataway, NJ, United States Joulé Full time

    Job Title: QC Analyst II Is this the next step in your career Find out if you are the right candidate by reading through the complete overview below. Location: Piscataway, NJ Hours/Schedule: M-F, 8:30 am - 5:00 pm (May require extended hours or weekends during manufacturing runs) Type: Temporary to Hire Overview We are seeking a QC Analyst II with a strong...


  • , AR, United States Kimberly-Clark Full time

    About the RoleWe are seeking a highly skilled Microbiology Quality Control Analyst to join our team at Kimberly-Clark. As a key member of our Microbiology Quality Control Laboratory, you will be responsible for ensuring the quality and safety of our products through microbiological testing and analysis.Key ResponsibilitiesPerform microbiological testing on...


  • United, United States Dale Workforce Solutions Full time

    Job Title:Quality FEP Business AnalystJob Description:We are seeking a skilled Business Analyst to join our team at Dale Workforce Solutions. As a Business Analyst for FEP Quality, you will work in a production environment handling transactions and providing business support to teams as needed.Key Responsibilities: Handle claims production tasks such as...


  • Des Moines, IA, United States Calculated Hire Full time

    Job Title: Financial Controls Analyst IIIDepartment: Supply Chain ManagementLocation: Des Moines, IAContract Duration: 4-month contract (W2)Work Schedule: Hybrid (3 days in-office)Desired Start Date: 11/18/2024Overview:Calculated Hire is seeking a Financial Controls Analyst III for a Fortune 100 Financial Services company. This role involves conducting...

  • IT Controls Tester

    2 weeks ago


    Malvern, PA, United States Entech Full time

    We’re living and working in the midst of a digital revolution, and the demand for optimized technology practices has never been more critical for businesses. At Entech, it’s our mission to help companies navigate the changing environment and accelerate digital realization through the power of solutions, services, and product platforms. With comprehensive...


  • Emmaus, PA, United States Heidelberg Materials US, Inc. Full time

    AutoReqId: 21151BR Pay Class: Salaried Non-Exempt Department: Quality Job Posting: The Role and the Company Heidelberg Materials provides the materials to build our future. Our future is sustainable. Our future is digital. And it goes way beyond cement, aggregates and ready-mixed concrete. Heidelberg Materials North America, previously known as Lehigh...


  • York, PA, United States Elgen Staffing Full time

    Our client, a global leader in packaged good solutions, has an immediate need for an experienced Quality Control Technician, to join our winning team in York. Interested in this role You can find all the relevant information in the description below. Our candidate of choice will ensure quality and operational compliance to the customer and CP...


  • Kansas City, MO, United States Insight Global Full time

    Materials Inventory Governance Analyst6 Month Contract + Extensions5 Days onsite Kansas CityRate 40-50/hrJob DescriptionInsight Global is looking for a Materials Inventory Governance Analyst to support one of the largest transportation companies across North America. This role will be located in Kansas City and will be onsite 5 days/week. This is a 6-month...


  • Charlotte, NC, United States Eliassen Group Full time

    Our well-known client in the South Charlotte area has a long-term position available for a Quality Assurance Analyst that has strong experience with testing APIs and writing complex SQL statements. The Quality Assurance Analyst will also be using Selenium and UFT to perform basic automation testing. The ideal Quality Assurance Analyst will have experience...


  • Chester, VA, United States FootBridge Company Full time

    Job Title: Project Controls Analyst You can get further details about the nature of this opening, and what is expected from applicants, by reading the below. Location: 11101 Old Stage Rd Chester, VA Duration: 12 months (strong possibility of extension) Start Date: 1st week of January Rate: $60 - 70/hr Per Diem: $178/day Hours: 40 hours per week, potentially...


  • Cambridge, MA, United States Vericel® Corporation Full time

    This role will be based in our Cambridge, MA location until our new state of the art facility located in Burlington, MA is ready.Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Quality Control professional looking to join and contribute to a commercial...


  • Malvern, Arkansas, United States BM Technologies, Inc. Full time

    Job OverviewBMTX is seeking a highly motivated and results-driven Senior Compliance Analyst to join the Compliance Monitoring and Testing Team within the Compliance business unit.The Senior Compliance Analyst will participate in the execution of reviews of various bank products, services, and related control processes in accordance with an established...


  • United, PA , USA, United States Dormakaba Group Full time

    Quality Control Technician IDormakaba is seeking a Quality Control Technician I to join our team in Reamstown, PA. As a Quality Control Technician I, you will play a crucial role in improving internal and external customer experience through supplier product monitoring, inspection process improvements, and recording/analyzing returned goods and...

  • Data Quality Analyst

    2 weeks ago


    Irving, TX, United States PTR Global Full time

    Job Title: The Data Quality AnalystLocation: Irving TexasPay Range: $60-$65 Hourly on W2****No C2C; only W2****Looking for Senior Data Quality Analyst with Finance/Banking DomainNeed locals to TampaJob Description:The Data Quality Analyst (Data Quality Sr. Analyst) helps to ensure data sourced and provisioned by different areas, meets all required Data...