Quality Assurance Materials Specialist

POINT Biopharma is an innovative, high-performance company focused on a hard problem: creating new cancer therapies that are more effective and have fewer side effects than traditional treatments. Our products are targeted radioligands, a technology that hold significant promise to treat cancer. Our company is growing rapidly: we just announced a phase 3 clinical trial for our novel radioligand based prostate cancer treatment, established our U.S. manufacturing center in Indianapolis, and have a pipeline of next generation oncology products in development. We are a creative and agile team accountable to a high standard: to be uniquely better. If you are searching for new and uniquely better career path, you should consider joining the POINT team.

TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA.

Location: Indianapolis, IN. Completed in Sept 2021, POINT's Indianapolis site is one of the largest state-of-the-art radiopharmaceutical manufacturing facilities in the world - almost as large as one and a half football fields.

Overview

• The position of Quality Assurance Materials Specialist at POINT Biopharma is responsible for the following:
• Performing inspection and release of incoming raw materials and components for use in GMP manufacturing and testing.
• Investigating quality complaints arising from supplier and raw material issues.
• Performing sampling of raw materials and components for quality control testing.
• Developing and executing AQL (acceptable quality level) sampling plans as required.
• Serving as the primary Quality Assurance point of contact for materials management.
• Managing change controls, CAPAs, and deviations within the eQMS relating to Materials Management.
• Updating and developing new procedures in coordination with the Materials Management team in a dynamic and fast-paced environment.
• The position is based in Indianapolis, Indiana, U.S. and directly reports to the Manager, Quality Operations.

Objectives

• To ensure the timely testing and release of materials used in GMP manufacturing.
• To ensure practices and procedures used in the Materials Management department and at the manufacturing facility for testing and release of materials meet the defined requirements in accordance with the Quality Management System and cGMP practices.

Accountabilities

• Approves and releases materials for daily use.
• Ensures coverage of urgent and weekend material releases.
• Documents QA metrics as pertaining to Materials Management.
• Reviews and approves Materials Management procedures, policies and forms in the electronic document system.

Requirements

Education and Experience

• BS/BA degree.
• 2 years of Quality Assurance work experience
• Strong knowledge of cGMP's, FDA, USP regulations and guidelines, as related to raw material management and testing.
• Demonstrated resource management and planning skills.
• Experience in performing and leading risk assessments.
• Experience working with incoming materials inspection.
• An excellent understanding and knowledge of Microsoft office products – Word, Excel, and Powerpoint.
• Experience with electronic data systems is a plus.

Competencies

• Excellent oral and written communication skills
• Demonstrated ability to function well in a cross-functional collaborative environment
• Ability to execute multiple projects under tight timelines
• Operate and execute with an extreme sense of urgency
• Excellent organizational and interpersonal skills
• Demonstrated proficiency in Microsoft Office (including Outlook, Word, PowerPoint, Excel)
• Managing priorities, and working in a fast-paced environment
• Operating multiple different programs and e-systems on a routine basis.

Why joining POINT today will be the right career move for you:

There is no shortage of demand for smart, qualified and hardworking people like yourself – and we strongly believe POINT is the right career move for you. Here is why:

• You will help establish and define an organization that will change the course of cancer therapies. and help thousands of people each year
• You will be challenged, and are expected to challenge us, as part of a results-oriented, high performance team, where everyone leaves their egos at the door and lets the best ideas win
• You will be provided the opportunity to participate in the financial value creation that occurs as POINT grows and becomes a mature pharmaceutical company
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