Quality Control Analyst II, Analytical [Contract to Hire]
Quality Control Analyst II, Analytical [Contract to Hire]
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1 Vacancy
Job Description
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 Iovances integrated Cell Therapy Center (iCTC). The Quality Control testing programs include but are not limited to in-process final drug product and stability testing with a focus on cell therapy products.
This role requires hands-on laboratory experience in at least two (2) of the following areas: cell culture / maintenance and cell count determination (NC-200) cell-based potency assays utilizing various immunoassays (ELISA ELLA etc.) platforms and/or identification / characterization / potency assays using multicolor flow cytometry platforms. This position will support the ramp-up of QC analytical release assays and other activities in a newly built facility for cell therapy products. This position works across different shifts. Depending on your assigned shift you may be required to work weekends and holidays to meet target turnaround times.
Essential Functions and Responsibilities
- Perform daily GMP Quality Control laboratory testing activities at the iCTC facility with minimal to no errors while ensuringtesting 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.
- Act as a technical subject matter expert (SME) on two (2) or more assays and train new laboratory personnel.
- Support thorough GMP investigations for out of specification test results and other quality events.
- Support technical problem solving for issues pertaining to GMP Quality Control.
- Support product stability programs including execution of stability testing and final reporting of stability data.
- Support data acquisition analysis and/or evaluation for non-routine testing.
- Assist in the generation and revisions and review of documentation such as SOP protocols and reports.
- Initiate and support quality documents such as deviations laboratory investigations CAPAs and change controls.
- Perform technical review of laboratory data and logbooks.
- Operate at a consistent and high level of efficiency producing high quality and accurate results.
- Support Health Authority inspections.
- Provide input to functional laboratory team meetings.
- Must adhere to Iovance Biotherapeutics core values policies procedures and business ethics
- Comply with Safety SOPs SDS sheets and laboratory procedures per company policy and OSHA regulations
- Other responsibilities as assigned
Required Education Skills and Knowledge
- Minimum of 5 years of related experience with a Bachelors degree; or 3 years and a Masters degree; or a PhD without experience; or equivalent work experience.
- Minimum three (3) years of GMP experience in the pharmaceutical industry within a Quality Control role
- Solid understanding and functional knowledge with hands-on experience with two (2) or more of the following: Multicolor Flow Cytometry Cell-based ELISA cell culture with cell enumeration (NC-200)
- Experience in technical writing (e.g. test methods SOPs protocols deviations CAPAs change controls etc.)
- Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
- Successfully interface with multi-disciplined teams
- Extremely detail-oriented with strong technical skills.
- High level of ownership and accountability.
- Demonstrate sense of urgency; ability to recognize time sensitivity.
- Proficient with using Microsoft Office applications (Outlook Excel Word and PowerPoint)
Preferred Education Skills and Knowledge
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.
Physical Demands and Activities Required:
- Must be able to wear all appropriate Personal Protective Equipment (PPE) including but not limited to: lab coat half face respirator as applicable safety glasses/goggles and nitrile gloves.
- Able to stand and/or walk 90% (and sit 10%) of the scheduled workday which may include climbing ladders or steps.
- Must be able to use near vision to view samples at close range.
- Able to crouch bend twist reach and perform activities with repetitive motions.
- Must be able to lift and carry objects weighing 20 pounds.
Mental:
Clear and conceptual thinking ability; excellent judgment troubleshooting problem-solving analysis and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.
Work Environment:
This position will work in both an office and a manufacturing setting. When in the lab you may be exposed to various chemicals/biochemical including latex and bleach. Additionally there is potential for variable noise levels equipment hazards strong odors and other detergents/sanitizers.
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions duties or local variances. Management retains the discretion to add or to change the duties of the position at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer our employees and applicants will be considered without regard to an individuals race color religion sex pregnancy national origin age physical and mental disability marital status sexual orientation gender identity gender expression genetic information military and veteran status and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities please contact .
By voluntarily providing information and clicking Submit Application you explicitly consent to the collection and use of your personal information for the purposes described above and in ourCandidate Privacy Notice.
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Required Experience:
Senior IC
Employment Type
Contract
