Quality Assurance Specialist

  • Anywhere

Company :
POINT Biopharma

Location :
Indianapolis, Indiana

Expiry Date :
Sat, 24 Apr 2021 23:59:59 GMT

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Description :
POINT Biopharma:

_Indianapolis, Indiana_

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.


Reporting into the Manager of Quality Assurance the Quality Assurance Specialist will establish and lead POINTs control system for cGMP documents.

Your responsibilities will include:

* Serve as the superuser/administrator for POINT electronic Quality Management System (eQMS).
* Provide guidance and support to plant personnel to ensure training and documentation practices are executed in accordance with cGMP, ICH Guidelines and the FDA Code of Federal Regulations for aseptic drug products.
* Manage deviations and the associated investigations within the eQMS.
* To participate in the successful establishment of a cGMP electronic Quality Management System (eQMS) which supports the sites satisfactory Review during the PAI by FDA regulatory authorities. The eQMS will be utilized to manage controlled documents, employee training, deviation investigations, and Corrective and Preventative Actions (CAPA).
* Document QA metrics and auditing activities.
* Train other employees on aspects of document control and utilization of the eQMS.
* Maintain administrative control of department files and records.
* Coordinate learning management system training requirements.
* Assign appropriate reviewers and approvers for procedures, policies and training in the electronic document system.
* Prepare status reports; assigns and monitors document numbers and reviews documents for accuracy and completeness.
* Coordinate migration of files from hard-copy system to electronic system
* To ensure all documentation practices at the manufacturing facility meet the defined requirements in accordance with the Quality Management System and cGMP practices.


Our Ideal candidate has:

* Bachelors degree is required
* 3-5 years working experience in Quality Assurance.
* An excellent understanding and knowledge of Microsoft office products Word, Excel, and Powerpoint.
* Experience with electronic data systems is a plus.
* Experience creating and editing in multiple file systems.
* Excellent oral and written communication skills
* Demonstrated ability to function well in a collaborative team environment
* Ability to 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 (including Outlook, Word, PowerPoint, Excel)
* Ability to collaborate with QA, CMC and regulatory colleagues to establish and justify release and stability specications for starting materials, intermediates, drug substances and drug products
* Manage multiple projects, set priorities, and work in a fast-paced environment
* Management reporting.

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
* Most importantly, you will spend everyday working on something important

If what we are saying resonates with you, please submit a cover letter and resume.


* Health Care Plan (Medical, Dental & Vision)
* Retirement Plan (401k, IRA)
* Life Insurance (Basic, Voluntary & AD&D)
* Paid Time Off (Vacation, Sick & Public Holidays)

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.