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POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT aims to transform precision oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. POINTs active clinical trials include FRONTIER, a phase 1 trial for PNT2004, a pan-cancer program targeting fibroblast activation protein- (FAP-), and SPLASH, the phase 3 trial for PNT2002 for people with metastatic castration resistant prostate cancer (mCRPC) after second-line hormonal treatment.

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

Location: Indianapolis, IN.

Overview

POINT Biopharma is an innovative, high-performance company focused on a hard problem: extending and improving the quality of life for patients enduring cancer. Our products are targeted radioligands, a technology that holds 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.

Based in Indianapolis, Indiana and reporting to Manager, Quality Systems, the position of Quality Assurance Administrator at POINT Biopharma is responsible for the following:

• Document and label control, including the issuing and tracking of documents and labels.
• Support the Quality team in the development, editing, and management of documents used throughout the POINT Quality Management System.
• Provide support to the eQMS (electronic Quality Management System) super user to establish and mange document workflows.
• Manage the GMP document repository, both paper based and electronic documents to ensure GMP compliance.

Objectives

• Ensure all documentation practices at the manufacturing facility meet the defined requirements in accordance with the QMS and cGMP practices.
• Participate in the successful creation and management of documentation used throughout the Indianapolis manufacturing facility.
• Work with colleagues to ensure consistency of documentation practice across the company.

Accountabilities

• Adhere to regulatory requirements by issuing and tracking document numbers and documents (including procedures, forms, and labels) in accordance with the POINT Document Management procedures (GMP, regulatory).
• Maintain administrative control of department files and records.
• Coordinate learning management system training requirements.
• Support the Quality Assurance Management to assign appropriate authors, reviewers and approvers for procedures, policies, and training in the electronic documentation systems.
• Prepare status reports; assigns and monitors document numbers and reviews documents for accuracy and completeness.
• Coordinate migration of files from hard copy to electronic system.
• Perform other duties as assigned by management.

Requirements

Education and Experience:

• Preferred Bachelors degree in Business Administration or Record Management.
• Minimum requirement High School diploma or GED.
• 2 years experience working in Quality Assurance or an administrative field is required.
• Excellent understanding, knowledge, and skill creating documents within Microsoft Office products (Word, Excel, PowerPoint) is required.
• Experience with electronic data systems is a plus.
• Experience creating and editing in multiple file systems.
• Time-oriented approach to handling queries and tasks.

Critical Competencies:

• Excellent oral and written communication skills.
• Demonstrated ability to function well in a collaborative team environment.
• Plan, develop and 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 products.
• Manage multiple projects, set priorities, and work in a fast-paced environment.

Benefits

• Eligible for annual incentive bonus plans and stock options
• Health Care Plan (Medical, Dental & Vision) 85% paid by employer and effective day 1
• Retirement Plan (matching 401k)
• Income Protection Insurance (Life AD&D, Short & Long-term disability) 100% employer paid
• Voluntary Income Protection Premiums paid by employee
• Paid Time Off (Vacation, Personal Days, Sick Days & Public Holidays)
• $500 fitness reimbursement per year
• $100 cell phone reimbursement per month

All applicants who are offered employment with POINT Biopharma will be subject to a background investigation. Offers of employment are contingent on the successful completion of a background investigation conducted in accordance with POINT Biopharma policy and state law.

POINT Biopharma does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

We do not accept unsolicited inquiries or resumes from agencies.