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Quality Control Specialist, External Operations
4 months ago
**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**:U_pdated resume_
**We are Hiring **We look forward to seeing you at the Job Fair.**
**Overview**
**Essential Functions and Responsibilities**
- Performs review and approval of CMO/CTL OOS investigations, deviations and other quality events.
- Performs review and approval of CMO/CTL change controls.
- Performs QC Data review and analysis of CMO release testing to support product lot release with adherence to turnaround times.
- Issue and write change controls and CAPAs when required.
- Supports technical problem solving for issues pertaining to GMP quality control.
- Supports generation and revisions of documentation, such as SOP, protocols, and reports.
- Trending of analytical performance.
- Operates at a consistent and exemplary level of efficiency, producing high quality and accurate results.
- Supports Health Authority inspections.
- Adheres to Iovance Biotherapeutics core values, policies, procedures, and business ethics.
- Performs miscellaneous duties as assigned.
**Required Education, Skills, and Knowledge**
- Minimum of a bachelor’s degree in biology, Biochemistry, Microbiology, Chemistry, or related scientific field and minimum 2 years of related experience is required.
- Should have experience with OOS investigations, deviations, change controls and CAPAs.
- Basic knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards
- Understanding and functional knowledge with hands-on experience with the following: Flow Cytometry, Cell based ELISA, cell culture (primary cells and cell lines) is a plus.
- Proficient in performing technical writing (e.g., test methods, SOP's, protocols, etc.)
- Successfully interface with multi-disciplined teams.
- Extremely detail-oriented with strong technical skills.
- Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
- High level of ownership and accountability.
- Demonstrate sense of urgency; ability to recognize time sensitivity.
**Preferred Education, Skills, and Knowledge**
- Bachelor’s degree with minimum 2 years of relevant experience
- Experience with cell therapy products is a plus.
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 appropriate Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
- Able to stand and/or walk 90% (and sit 10%) within your scheduled workday, which may include climbing ladders or steps.
- Ability to crouch, bend, twist, reach, and perform activities with repetitive motions.
- Must be able to lift and carry objects weighing up to 45
- Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
- Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects when not in a lab setting.
- Must have visual acuity to prepare and analyze data and figures, view a computer screen, and read extensively.
- This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
- Must be able to communicate with others to exchange information.
**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 job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.
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.
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