Quality Control Analyst/Senior Quality Control Analyst

Overview

Accelerate your career with NorthStar!

 

NorthStar Medical Radioisotopes is seeking individuals with a desire to work within the pharmaceutical industry who possess an Intense Customer Focus, are Proactive and operate with Open-Minded Intelligence, a Can-Do Mindset and enjoy working in a highly Collaborative manner.  We are a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer along with customized radiopharmaceutical development services.

 

At NorthStar, we prioritize professional growth of our employees. Working with our cutting-edge technology offers a stimulating and rewarding environment for talented individuals who want to be part of our exciting and growing business. We are committed to providing our employees with fulfilling work experiences and valuable career development opportunities. 

 

Innovative technology, opportunities for career advancement, and competitive compensation are just the beginning. NorthStar offers health and life insurance, 401K match, paid holidays, and paid time off, paid parental leave and all NorthStar employees are eligible on day one for our annual bonus and equity incentive plans.

Position

The primary role of this position is to conduct and validate various biological and analytical quality control assays associated with the processing of radiopharmaceutical isotopes and drugs to ensure compliance with established standards.   This role requires extensive training on radiation safety including ALARA (“as low as reasonably achievable”) principles.  

 

The Senior Quality Control Analyst will lead various activities, as further described below.  

 

Duties will be completed in compliance with applicable regulatory agency standards.

 

This position supports production in a 24-hour manufacturing facility which means your schedule provides days off during the week when weekend work is required.  Early morning, late evening, weekend, and some holiday work will be required with occasional overtime.

Responsibilities

• Proficiently operate analytical instrumentation (i.e. scintillation counters, HPGe, ICP-MS, IC). This may also include dose calibrators, survey meters, dosimetry monitors, and wipe test counters.
• Participate in authoring and/or revision of Standard Operating Procedures (SOPs) and forms in the eQMS system.
• Perform incoming inspections of raw materials and components and release in the ERP system.
• Handle radioactive material, which includes monitoring radioactive dose, sampling, aliquoting, and performing contamination surveys.
• Perform QC functions for ISO 7 and ISO 8 cleanroom cGMP manufacturing operations.
• Train to use manipulators for remote handling of high activity isotopes and radiopharmaceuticals inside hot cells.
• Execute microbiological, chemical, radiochemical, and stability testing.
• Lead and facilitate trouble shooting and root cause analysis for investigations for nonconformances

 The Senior Quality Control Analyst will have additional responsibilities, including:

• Assist with the leadership and facilitation of trouble shooting and problem solving in order to learn possible solutions to problems and issues that may arise.
• Develop and validate Quality Control (QC) Radiochemistry test methods.
• Participate in internal assessments and regulatory audits as the SME, as required.
• Monitor equipment and instrumentation (HPGe, ICP-MS, HPLC, IC, dose calibrator, LSC) to ensure proper operation and calibration
• Mentor and train other members of QC, including new hires, to perform QC testing and procedures.
• Maintain QC Lab: Managing inventory and review of logbooks etc.
• Coordinate testing and EM schedule to ensure Production support.

After 3 months you will:

• Be qualified to enter controlled spaces such as laboratories
• Trained on ALARA principles and RAD safety
• Be able to perform basic environmental monitoring and receiving inspection techniques
• Provide support to site operational readiness

 After 6 months you will:

• Be qualified on more advanced analytical techniques such as HPLC
• Support final product testing and batch processes
• Be qualified to provide training to other team members on certain QC functions

Qualifications

Understanding of pharmaceutical manufacturing processes, 21 CFR 210/211/820 and familiarity with batch production records (BPR) preferred. Familiarity with alpha, gamma, and beta spectroscopy is a plus.

 

Quality Control Analyst Qualifications

Bachelor’s Degree in Chemistry, Biology, or other related scientific discip