Quality Control Analyst
2 weeks ago
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 REQUIRED SKILLS AND EXPERIENCE:-Minimum one year of relevant GMP QC work experience in Pharmaceutical lab -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 specifically with Flow Cytometry -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)NICE TO HAVE SKILLS AND EXPERIENCE:-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
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Quality Control Analyst
4 weeks ago
Malvern, United States Insight Global Full timeCompensation & Details:2 OpeningsFully 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...
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Quality Control Analyst
2 weeks ago
Malvern, United States Insight Global Full timeJOB 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 --...
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Quality Control Analyst
2 weeks ago
Malvern, United States Insight Global Full timeJOB 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 --...
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Quality Control Analyst
2 weeks ago
Malvern, PA, United States Insight Global Full timeJOB 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 --...
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Quality Assurance Analyst
4 weeks ago
Malvern, PA, United States Insight Global Full timeCompensation & 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...
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Quality Assurance Analyst
1 week ago
Malvern, PA, United States Insight Global Full timeJOB DESCRIPTION: Make sure to apply with all the requested information, as laid out in the job overview below. 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...
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Controls Testing Analyst
6 days ago
Malvern, United States Customers Bank Full timeAt Customers Bank, we believe in working hard, working smart, working together to deliver memorable customer experiences and having fun. Our vision, mission, and values guide us along our path to achieve excellence. Passion, attitude, creativity, integrity, alignment, and execution are cornerstones of our behaviors. They define who we are as an organization...
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Senior Assurance Analyst
3 days ago
Malvern, United States Pennsylvania Staffing Full timeSenior Assurance AnalystBalfour Beatty Investments is a global infrastructure investor operating in the UK, US, and Canada. We provide the investment capability to deliver complex infrastructure projects. Over the past 15 years, Balfour Beatty Investments has established itself as one of the largest investors in the PPP industry, building a portfolio of more...
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Data Analyst
1 week ago
Malvern, PA, United States Nava Software Solutions Full timeNAVA Software solutions is looking for a Data Analyst Details: Data Analyst Engineer Location: Malvern, PA - Hybrid Duration: 6 -12 months Two Round Interview Process Round 1: Technical Interview Round 2: Case Study (Candidates will be given a takeaway case study with the expectation of returning it completed within a few days) Need strong communication...
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Data Analyst
2 weeks ago
Malvern, PA, United States Nava Software Solutions Full timeNAVA Software solutions is looking for a Data Analyst Details: Data Analyst Engineer Location: Malvern, PA - Hybrid Duration: 6 -12 months Two Round Interview Process Round 1: Technical Interview Round 2: Case Study (Candidates will be given a takeaway case study with the expectation of returning it completed within a few days) Need strong communication...
