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Lead Quality Control Specialist, Sample Management
2 months ago
Overview
The Lead Quality Control Specialist, Sample Management is responsible for sample inventory management as well as internal and external sample distribution, including storage and shipping of QC samples under appropriate conditions.
Essential Functions and Responsibilities:
- Manage QC sample logistics for raw material, in-process, and final product samples including sample storage, sample inventory and reconciliation, scheduling, and shipping in LIMS based system.
- Maintain sample integrity by ensuring that all samples are managed (i.e., stored; handled; shipped) in compliance with procedures, specifications, and cGMP
- Provide timely distribution of samples internally and externally to testing vendors
- Ensure that sample inventory systems are maintained and accurate
- Maintain current knowledge base of regulations, corporate policies, and industry best practices, trends, and standards to ensure that the logistics function remains in compliance with applicable requirements.
- Create and improve procedures to ensure optimal compliance with cGMP
- Support audits and inspections
- Packaging of samples using temperature controlled dewars, cold packs, and dry ice
- Perform Quality Control activities
- Performs peer review of logbooks
- Must adhere to Iovance Biotherapeutics core values, policies, procedures, and business ethics
- Comply with safety SOP’s, SDS sheets, and laboratory procedures per company policy and OSHA regulations
- Complete training sessions and ensure training documentation is maintained
- Adherence to GMP and SOP procedures including GDP
- Responsible for accurate cycle count performance
- Act as a subject matter expert – Sample Management
- Transfer of knowledge to new employees and peers
- Lead process improvement cross functional projects
- Responsible for completing monthly level 1 audits
- Complete end of shift report for team
Required Education, Skills, and Knowledge:
- Bachelor’s degree or 4+ years of relevant GMP and Quality Sample Management experience
- Detail-oriented with strong mathematical skills
- Excellent written and verbal communication skills
- Strong collaboration, time management, and organizational skills are required
- Proven ability to effectively collaborate with a wide range of stakeholders
- Excellent judgment and creative problem-solving skills
- Ability to work in a fast-paced and dynamic environment
- Hands-on laboratory experience with sample handling, inventory, and cryo-shipping
- Ability to lead by example
Preferred Education, Skills, and Knowledge:
- Experience with inventory and/or logistics in the pharmaceutical industry
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 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.
- Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
- 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
- Ability to meet deadlines
Work Environment:
- This position will work in an office, with occasional visits to the Quality Control labs.
- When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
- Able to work in cleanroom with biohazards, human blood components, and chemicals.
- Potential exposure to noise and equipment hazards and strong odors.
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 individual’s 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 careers@iovance.com.
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 our Candidate Privacy Notice.
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