Senior Quality Control Analyst
1 month ago
We are looking for a person that has hands-on laboratory experience handling primary and/or continuous cell lines and the execution of cell-based potency and identification assays using various immunoassay (ELISA, etc.), flow cytometry platforms, as well as cell count/viability determinations using the NC-200 platform. This position will support the ramp up of QC and other activities in a newly built facility for cell therapy products.
Essential Functions and Responsibilities
- Act as a technical subject matter expert (SME) for potency and flow testing activities
- Mentor and train new laboratory personnel
- Perform daily GMP Quality Control laboratory testing activities at the facility with minimal to no errors while ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations
- Perform data analysis and final result reporting to support product lot release with adherence to turnaround times
- Perform all activities with respect to GMP/GDP compliance.
- Support generation and revisions of documentation, such as SOP, protocols and reports, deviations, laboratory investigations, CAPAs and change controls
- Support thorough GMP investigations for out of specification test results and other quality events (initiate DRs and LIRs)
- Support technical problem solving for issues pertaining to GMP Quality Control
- Support product stability programs including execution of stability testing and stability data analysis
- Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results.
- Perform peer and/or technical review of laboratory data and logbooks
- Analysis of assay-specific analytical performance trending
- Support Health Authority inspections
- Provide input to functional laboratory and cross functional team meetings
- Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results
- Other responsibilities as assigned
Required Education, Skills, and Knowledge
- Bachelor’s degree in a relevant discipline (biological sciences or equivalent).
- Minimum five (5) years of experience in the pharmaceutical industry within a GMP Quality Control role
- Experience with Flow Cytometry and/or Cell based ELISA platforms
- Successfully interface with multi-disciplined teams.
- Extremely detail-oriented with strong technical skills.
- Ability to effectively manage multiple priorities involving aggressive, changing timelines at a high level of productivity.
- High level of ownership and accountability.
- Demonstrate sense of urgency; ability to recognize time sensitivity.
-
Senior Quality Control Specialist
2 weeks ago
Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full timeJob OverviewPosition Title: Lead Quality Control AnalystCompany: Iovance Biotherapeutics IncSalary: CompetitiveCompany Overview:Iovance Biotherapeutics is an innovative, late-stage organization dedicated to the advancement and commercialization of groundbreaking cancer immunotherapies. The Lead Quality Control Analyst will play a pivotal role in overseeing...
-
Senior Quality Control Analyst
1 month ago
Philadelphia, United States Planet Pharma Full timeWe are looking for a person that has hands-on laboratory experience handling primary and/or continuous cell lines and the execution of cell-based potency and identification assays using various immunoassay (ELISA, etc.), flow cytometry platforms, as well as cell count/viability determinations using the NC-200 platform. This position will support the ramp up...
-
Senior Quality Control Specialist
2 weeks ago
Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full timeJob OverviewPosition Title: Lead Quality Control AnalystCompany: Iovance Biotherapeutics IncSalary: CompetitiveCompany Overview:Iovance Biotherapeutics is an innovative company at the forefront of developing and commercializing advanced cancer immunotherapies. We are seeking a dedicated Quality Control Analyst to enhance our quality control testing...
-
Lead Quality Control Analyst
4 weeks ago
Philadelphia, United States Iovance Biotherapeutics Inc Full timeJob DescriptionJob DescriptionSalary: Overview Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. The Quality Control Analyst will support quality control testing operations at Iovance’s integrated Cell Therapy Center (iCTC). The Quality Control testing programs...
-
Lead Quality Control Analyst
1 week ago
Philadelphia, United States Iovance Biotherapeutics Inc Full timeJob DescriptionJob DescriptionSalary: Overview Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. The Quality Control Analyst will support quality control testing operations at Iovance’s integrated Cell Therapy Center (iCTC). The Quality Control testing programs...
-
Lead Quality Control Analyst
3 months ago
Philadelphia, United States Iovance Biotherapeutics Inc Full timeJob DescriptionJob DescriptionSalary: Iovance is hosting an onsite Job Fair. Where: Iovance Cell Therapy Center (iCTC) Location: 300 Rouse Blvd Philadelphia, PA 19112 Date: Monday, June 24, 2024 Time: 12pm to 6pm (EDT) What to bring: Updated resumeWe are Hiring! We look forward to seeing you at the Job Fair. Overview Iovance...
-
Quality Assurance Analyst
1 week ago
Philadelphia, United States placingITpeople Full timeJob Title: QA Certification Specialist / AnalystLocation: PhiladelphiaWho We Are:We are a specialized recruitment agency, placingITpeople, we represent leading tech companies in Canada and the USA, connecting top-tier talent with innovative organizations.Who You Are:You are a Senior QA Specialist with at least 3 years of payment industry experience as a...
-
Quality Assurance Analyst
1 week ago
Philadelphia, United States placingITpeople Full timeJob Title: QA Certification Specialist / AnalystLocation: PhiladelphiaWho We Are:We are a specialized recruitment agency, placingITpeople, we represent leading tech companies in Canada and the USA, connecting top-tier talent with innovative organizations.Who You Are:You are a Senior QA Specialist with at least 3 years of payment industry experience as a...
-
Quality Analyst
3 months ago
Philadelphia, United States Bainbridge Health Full timeJob DescriptionJob DescriptionQuality AnalystOverview: Bainbridge Health unlocks the full value of pharmacy data to enhance the safety, efficiency and reliability of medications. Our goal is to make it easier for pharmacy and safety leaders to prevent patient harm, reduce avoidable waste, and help clinicians regain control of their time. A spin-out company...
-
Senior Analyst
7 days ago
Philadelphia, United States QUAD, a SolomonEdwards Company Full timeSenior Analyst Our client is seeking a Senior Analyst in the Philadelphia Suburban area.The Senior Analyst is a position that will work with a Senior Manager of Operations Analysis and will own core financial aspects of Operations including direct and indirect labor and field infrastructure.The Senior Analyst will be responsible...
-
Senior Analyst
1 week ago
philadelphia, United States QUAD, a SolomonEdwards Company Full timeSenior Analyst Our client is seeking a Senior Analyst in the Philadelphia Suburban area.The Senior Analyst is a position that will work with a Senior Manager of Operations Analysis and will own core financial aspects of Operations including direct and indirect labor and field infrastructure.The Senior Analyst will be responsible...
-
Quality Control Technician
4 days ago
philadelphia, United States Planet Pharma Full timeQuality Control Technician needed!Summary:The Quality Control Analyst I – Sample Management will ensure time-sensitive distribution of quality control samples in support of QC-related activities. They will be responsible for sample inventory management as well as internal and external sample distribution, including storage and shipping under appropriate...
-
Quality Control Technician
4 days ago
Philadelphia, United States Planet Pharma Full timeQuality Control Technician needed!Summary:The Quality Control Analyst I – Sample Management will ensure time-sensitive distribution of quality control samples in support of QC-related activities. They will be responsible for sample inventory management as well as internal and external sample distribution, including storage and shipping under appropriate...
-
Quality Control Technician
3 days ago
Philadelphia, United States Planet Pharma Full timeQuality Control Technician needed!Summary:The Quality Control Analyst I – Sample Management will ensure time-sensitive distribution of quality control samples in support of QC-related activities. They will be responsible for sample inventory management as well as internal and external sample distribution, including storage and shipping under appropriate...
-
Senior Manager, Microbial Quality Control
2 weeks ago
Philadelphia, Pennsylvania, United States EPM Scientific Full timeA leading biotech firm is expanding its microbiology division. This role will be pivotal in the formulation and management of the organization's microbial contamination control protocols, as well as facilitating new product transfers and conducting microbiological risk evaluations and trend analyses. As the Senior Manager of the Microbiology department, you...
-
Senior Cost Analyst
2 weeks ago
Philadelphia, Pennsylvania, United States The Ladders Full timeJob TypeFull-timeDescriptionOverviewThe Ladders is seeking a motivated and self-assured professional to join our finance team as a Senior Cost Analyst. This role will provide essential support to the Corporate Controller in various financial operations, including financial closing, banking transactions, and comprehensive reporting.The Senior Cost Analyst...
-
Quality Control Analyst II
3 months ago
Philadelphia, United States Iovance Biotherapeutics Inc Full timeJob DescriptionJob DescriptionSalary: Iovance is hosting an onsite Job Fair. Where: Iovance Cell Therapy Center (iCTC) Location: 300 Rouse Blvd Philadelphia, PA 19112 Date: Monday, June 24, 2024 Time: 12pm to 6pm (EDT) What to bring: Updated resumeWe are Hiring! We look forward to seeing you at the Job Fair. Overview The Quality Control...
-
Certification Quality Analyst
2 weeks ago
Philadelphia, Pennsylvania, United States Jobot Full timeAbout the Company:This organization is a prominent player in the fintech sector, recognized for its consistent growth and profitability. They offer an attractive compensation package that reflects their commitment to employee satisfaction.Position Overview:This role involves overseeing the quality assurance and certification processes for payment devices....
-
Quality Control Analyst I
3 months ago
Philadelphia, United States Iovance Biotherapeutics Inc Full timeJob DescriptionJob DescriptionSalary: Iovance is hosting an onsite Job Fair. Where: Iovance Cell Therapy Center (iCTC) Location: 300 Rouse Blvd Philadelphia, PA 19112 Date: Monday, June 24, 2024 Time: 12pm to 6pm (EDT) What to bring: Updated resumeWe are Hiring! We look forward to seeing you at the Job Fair. OverviewThe Quality Control...
-
Quality Control Analyst I, Microbiology
1 month ago
Philadelphia, United States Iovance Biotherapeutics Inc Full timeJob DescriptionJob DescriptionSalary: Overview The Quality Control Analyst will support quality control testing operations at Iovance’s Cell Therapy Center (iCTC). The quality control testing programs include in-process and final drug product microbial testing such as bioburden, endotoxin, gram stain, environmental monitoring, and sterility...