Total Quality Senior Specialist jobs in Pennsylvania

Overview

The Quality Release Specialist will support review of documentation and support releasing of materials and products.

Specific Responsibilities

• Ensure compliance to cGMPs and facility procedures. Interface with functional groups, such as Manufacturing, Quality Control, and Document Control, to determine events (errors, deficiencies, discrepancies, deviations and other observations) and report to management.

• Review batch records and related production documentation, ensuring resolution of all identified issues prior product disposition.
• Work with internal functions to address all identified issues in a timely manner. Reports errors, deficiencies, discrepancies, and observations to management.

• Review QC data

• Disposition incoming materials.
• Disposition of Product Lots and creation of supporting documentation for release.
• Issuance of batch records and labels.

• Maintain and report on Quality Metrics.
• Support lot closure.

• Assist with investigation of manufacturing deviations, OOS results, temperature excursions and other non-conformances.
• Other projects as assigned.

Education and Qualifications

• A Bachelor’s Degree in Science, Engineering, or a related technical discipline.
• At least two years of experience in a regulated industry.
• Working knowledge of cGMP regulations.
• Prior experience with review of QC data specific to cell therapy testing.
• Strong administrative skills including use of Microsoft Word, Excel, and PowerPoint.
• Attention to detail.
• Knowledge of QMS systems 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 (This would need to be adjusted by HRBP depending on the position and needs using the assessment form)

• 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; and ability to meet deadlines

Work Environment

This job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible.  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 careers@iovance.com.

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