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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.
TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA.
Location of work: 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.
Reporting into the Senior Director of Quality Assurance and Quality Control, the Quality Assurance Specialist will be responsible for:
- Creation of standard operating procedures and other quality documentation.
- Supporting the organization with continued compliance and monitoring conformance to established internal procedures and regulatory standards.
- Batch record review and final batch release.
- Supplier audits and qualification.
- Providing 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.
- Managing quality events and the associated investigations at the site.
Objectives and Accountabilities
- Participate in the successful implementation of a quality system which supports the sites clinical manufacturing goals, and satisfactory review during a pre-approval inspection by FDA regulatory authorities. This will include document management, investigations, audits and the corrective action/preventive action program.
- Ensure all quality practices at the manufacturing facility meet cGMP, EU Annex 1, and ICH regulatory requirements.
- Successful migration of the quality system from a manual system to a qualified electronic quality system.
- Develop processes and procedures for the quality department, under the guidance of the QA Manager.
- Train other employees on aspects of document control and utilization of the eQMS.
- Coordinate learning management system training requirements.
- Author investigations and procedures.
- Assign appropriate reviewers and approvers for procedures, policies and training in the electronic document system.
Requirements
- 4-year degree at an accredited university is required. Degree in the Life Sciences is an asset.
- 3-5 years previous experience working in a Quality Assurance role.
- Experience in pharma or biotech, or medical device industry is preferred.
- An excellent understanding and knowledge of Microsoft office products Word, Excel, and PowerPoint.
- Experience with electronic data systems is a plus.
- Position is required to work Monday to Friday during regular core business hours. In addition, up to 6 hours every other weekend and every other holiday.
Competencies
- 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 technical writing
- Ability to manage multiple projects, set priorities, and work in a fast-paced environment
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 resonate with you, please submit a resume.
Benefits
Health Care Plan (Medical, Dental & Vision) - effective day 1
Retirement Plan (401k - up to 2% match with immediate vest)
Income Protection Insurance (Life AD&D, Short & Long-term disability) 100% employer paid
Voluntary Income Protection Premiums paid by employee
Paid Time Off (Vacation, Sick & Public Holidays)
$500 fitness reimbursement per year
$50 cell phone reimbursement per pay cycle
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.
POINT Biopharma
