Senior Quality Assurance Specialist Investigations

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.
• Perform miscellaneous duties as assigned.

Required Education Skills and Knowledge

• A Bachelors Degree in Science Engineering or a related technical discipline.
• 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 decisionmaking and building relationships
• Able to effectively work in a dynamic / fastpaced 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 multidiscipline 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 problemsolving analysis and discretion; ability to handle workrelated stress; ability to handle multiple priorities simultaneously; and ability to meet deadline.

Work Environment:

• 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.

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 equalopportunity employer our employees and applicants will be considered without regard to an individuals 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 .

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