Senior Quality Assurance Specialist

Overview 

The Senior Quality Assurance Specialist will report to the Manager, Quality Assurance. The position will support the quality and regulatory compliance of commercial and clinical products including manufacturing, testing, and release at contract service providers.  Further, the position will be responsible for ensuring that these operational activities are maintained in accordance with GMPs, global health authorities’ requirements and expectations.

This position is Monday-Friday

8:00 am – 5pm 

Specific Responsibilities 

• Represent Iovance QA by working on-site at the CMO for up to 5 days per week.
• Support CMO manufacturing, testing, and release activity on weekends, as needed.
• Establish direct lines of communication with the CMO QA functions.
• Review/approve master/executed batch records for manufacturing, testing, of raw materials and finished products. 
• Lead/manage investigations and deviations systems to ensure compliance at CMO.
• Release/reject clinical lots and issue appropriate release certificates.  Maintain batch record files and associated documentation.
• Provide QA oversight and support for Change Requests internally and at CMO.
• Develop, or review, Standard Operating Procedures (SOPs) required for supporting system change/enhancement to ensure compliance with Good Manufacturing Practices (GMPs) requirements
• Support/Represent Quality in creation and presentation of Quality Management Review metrics and Annual Product Quality Review, as necessary 
• Interface and support management of CMOs as needed
• Support other quality systems/operations activities as requested
• Support in regulatory inspection and inspection readiness activities
• Other duties as assigned

Education and Qualifications

• BA/BS degree in life sciences discipline or equivalent
• 5 years of biopharmaceutical industry experience
• Direct experience with review of clinical and commercial manufacturing documentation and release of clinical and commercial product. Cell therapy experience is a plus.
• Strong working knowledge of GMPs and Health Authority standards and expectations in both the US and Europe.
• Ability to follow through on all activities to ensure projects are completed as planned.
• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.
• Demonstrated ability to collaborate and influence across organization to gain support and commitment for team goals.
• Strong professional interpersonal and communications skills, both verbal and written to provide clear direction for the business, vendors, internal stakeholders.
• Ability to meet deadlines and multi-task efficiently; must be willing to work a flexible schedule.
• Proficient with the Microsoft Office Suite, Word, Excel, PowerPoint and Project.

Physical Demands and Activities Required:

• Must be able to wear appropriate cleanroom attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
• Must meet requirements for and be able to wear a half-face respirator.
• Able to stand and/or walk 90% (and sit 10%) of the scheduled workday, which may include climbing ladders or steps.
• Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing 45 pounds.

Mental:

• Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to manage multiple priorities simultaneously; and ability to meet deadlines. 

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 a Lab setting with various chemical/biochemical exposures, including latex and bleach.
• Able to work in a cleanroom with biohazards, human blood components, and chemicals.
• Potential exposure to noise and equipment hazards and strong odors.

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