Quality Assurance Specialist Jobs

Overview

Iovance is seeking a Quality Assurance (QA) Specialist with experience in Quality Systems and Compliance in the Pharmaceutical / Biotechnology industry.

This individual will be responsible for Quality System and Compliance activities to ensure GXP compliance in accordance with local and country regulations and guidelines, as well company policies and procedures. The selected team member should be innovative, energetic, collaborative, express a strong desire to learn and take ownership and accountability for Quality.

The Specialist will oversee Quality Assurance activities including, but not limited to supplier performance metrics, SCARs, Temperature Excursion events/ disposition, and support Quality System records such as CAPAs/ Change Controls, Deviations, and related QA Compliance tasks. The successful candidate will be a key member of an-established team who is passionate about working with others in complex, changing, and fast-paced environments.

Essential Functions And Responsibilities

• Support management with other Quality System and Compliance-related tasks
• Create, oversee, and maintain supplier metrics/ performance
• Oversee and maintain the temperature excursion program to ensure immediate disposition of events based on supporting stability data
• Oversee and maintain the supplier correction action (SCAR) program to ensure timely closure of records
• Support and assist management with commercial inspection readiness through mock inspections, internal audits, or other activities as needed
• Represent the Quality System and Compliance group in cross-functional projects where applicable
• Support management with review, coordination, processing of Quality records including Deviations, Change Controls, CAPAs, OOS, and Complaints within the electronic quality management system (EQMS)
• Process supplier questionnaires in support of the supplier qualification program

Travel

• Up to 5% domestic travel

Required Education, Skills, And Knowledge

• Current and working knowledge of United States Code of Federal Regulations, ICH Guidelines, EU, ISO, and/or other local government regulatory requirements
• Proven ability to manage multiple projects while maintaining quality
• Strong interpersonal skills and ability to work collaboratively with colleagues cross functionally
• Strong computer skills including MS Office (Word, Excel, PowerPoint, MS Project)
• Working knowledge of GMP and data integrity principles (21 Part 210/211 and 21 CFR Part 11/ Annex 11)
• Experience reviewing quality agreements or contract preferred, but not required
• BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college with 3+ years relevant experience
• External and/or internal audit experience preferred, but not required
• Working knowledge of MasterControl or other programs such as TrackWise, Veeva, or other related eQMS programs

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 (This would need to be adjusted by HRBP depending on the position and needs using the assessment form)

• 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.
• 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 be able to remain in a stationary position standing or sitting for prolonged periods of time.

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.

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 [email protected].

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