Senior Quality Control Analyst - Raw Materials - 2nd Shift

Overview

The Senior Quality Control Analyst is responsible for the sampling release testing data review and vendor qualification for all raw material lots received for use in the manufacturing of product at the Iovance iCTC site. These activities include chemical and biological raw materials component inspection and final packaging. A good understanding of QC test methods and raw materials release requirements per USP and EP compendia is desired. Experience working in a GMPregulated environment is essential. The position will report to the Senior Manager Quality Control Raw Materials.

2nd Shift: Monday Friday 3:00pm 11:30pm.

Essential Functions and Responsibilities

Perform daytoday activities for raw material release operations.
Perform Acceptable Quality Level (AQL) sampling and inspection.
Perform Carbon Dioxide (CO2) sampling and testing.
Support technical review of AQL CO2 testing and other raw material releases.
Support all quality events and tasks associated to raw material release.
Author review and/or execute SOPs protocols reports specifications and other quality control documents as applicable.
Support raw materials vendor qualification program.
Support efforts in ongoing readiness for regulatory inspections and compliance audits.
Participate in investigations for outofspecification test results corrective actions and verification of effectiveness.
Support problem solving for technical issues pertaining to raw material testing and release.
Operate at a consistent and exemplary level of efficiency producing high quality and accurate results in a fastpaced environment.
All duties are performed with supervision and oversight.
Provide supervision and oversight to entrylevel analysts.

Required Education Skills and Knowledge
Bachelors degree in a relevant discipline (biological sciences or equivalent).
Minimum five (5) years in a GxP regulated setting (pharmaceutical or biotechnology industry)
Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines.
Strong analytical and technical background in compendial testing and related equipment including wet chemistry FTIR UV/VIS KF Titration and GC methodologies.
Experience in raw material inspection and testing practices.
Experience with quality events including OOS investigations.
Strong technical background and familiarity with laboratory control operations and quality systems.
Experience with lab and data management systems (LIMS Empower Phenix).
Broad knowledge of biological drug development with respect to Quality Control.
Demonstrated ability to communicate with external partners with respect to quality control activities.
Extremely detailoriented with strong analytical written and verbal communication skills.
Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
Demonstrate sense of urgency; ability to recognize time sensitivity.
Flexible and adaptable style with an eagerness to take on challenges.
Comfortable in a fastpaced company environment with minimal direction and able to adjust workload based on changing priorities.
Problem solver who not only identifies issues but leads efforts to resolve them.

Preferred Education Skills and Knowledge

Experience with cell and/or gene therapy products 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:

Must be able to wear appropriate Personal Protective Equipment (PPE) i.e. safety glasses shoes vest.
Able to stand and/or walk 90% (and sit 10%) of a 10hr day which may include climbing ladders or steps.
Must be able to use near vision to view samples at close range
Able to crouch bend twist reach and perform activities with repetitive motions.
Must be able to lift and carry objects weighing 25 pounds.

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.
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 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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