Senior Quality Assurance Specialist, Investigations Philadelphia, PA

Iovance Biotherapeutics, Inc.; Philadelphia (Philadelphia County); On-site; USD 85,000 - 110,000; Full time

Job summary

A leading company in the biopharmaceutical sector seeks a Senior Quality Assurance Specialist in Philadelphia. This role involves ensuring compliance with cGMP while providing oversight for manufacturing and quality control processes. The ideal candidate will have significant experience in regulated environments and demonstrate strong organizational and technical skills.

Qualifications

• 8+ years of experience in a regulated industry with a Bachelor's degree.
• 5+ years of experience specifically in a role requiring compliance oversight.
• Detail-oriented with strong administrative and technical skills.

Responsibilities

• Ensure compliance with cGMPs and support all manufacturing operations.
• Maintain and review quality control procedures and reports.
• Collaborate with teams to address quality issues promptly.

Skills

cGMP regulations

Planning and organizing

Decision-making

Relationship building

Detail oriented

Technical skills

Education

Bachelor’s degree

Master’s degree

PhD

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

MasterControl

Job description

Senior Quality Assurance Specialist, Investigations

Philadelphia, PA

Overview

The Senior Quality Assurance Specialist, Operations Investigations role will support review of deviations, investigations, protocols to support release of materials and products. The Sr. Quality Operations Investigations Specialist will also ensure compliance to Iovance procedures by supporting laboratory investigations and manufacturing deviation reviews.

Essential Functions andResponsibilities:

• 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 escalate to management.
• Responsible for providing quality oversight for site manufacturing operations and quality control at the iCTC.
• Accurate and timely maintenance and review of procedures, methods, protocols, and reports as required
• Collaborate with internal functions to address all identified issues in a timely manner. Determine how best to document issues requiring investigation within the Quality System.
• Providing Quality and compliance oversight to manufacturing, QC, and MSAT
• Coordinating deviation and investigation reviews to support release of final product and materials.
• Ensure accurate and timely review of manufacturing and laboratory investigations
• Identifying and escalating any trends to management
• Reports errors, deficiencies, discrepancies, and observations to management that could impact product Quality on release.
• Ensure deviations and investigations do not adversely impact timely lot closure, as required.

Required Education, Skills, and Knowledge

• Minimum of 8 years of related experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years experience; or equivalent experience.
• At least five years of experience in a regulated industry.
• Proficient knowledge of cGMP regulations.
• Perform routine activities with minimal oversights.
• Prior experience with review of Manufacturing and/or QC data specific to cell therapy testing preferred.
• Strong administrative skills including use of Microsoft Word, Excel, and PowerPoint.
• Must be skilled in planning and organizing, decision-making, and building relationships
• Able to effectively work in a dynamic / fast-paced environment
• Extremely detail oriented with strong technical skills.
• Knowledge of MasterControl is preferred.
• High level of accountability and ownership.
• Demonstrate a sense of urgency ability to recognize time sensitivity.
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
• Successfully interface with multidisciplined teams.

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; and ability to meet deadline
• This position will work in both an office and a manufacturing lab setting.
• When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.

#LI-onsite

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 [e-mail] .

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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