What are the responsibilities and job description for the Quality Assurance Specialist position at NorthStar Medical Radioisotopes?
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 Quality Assurance (QA) Specialist is responsible for providing QA input and guidance for Manufacturing, Supply Chain, Quality, and R&D activities. The QA Specialist will perform all responsibilities in accordance with company policies, procedures, global regulations and safety requirements.
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, weekend, and some holiday work will be required.
Responsibilities
- Review and approve documents in support of manufacturing and quality testing including batch records, test data, and receiving inspection.
- Review and assess non-conformances; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending.
- Review, approve and facilitate change controls including tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness.
- Support remediation efforts to negative quality trends.
- Interact with all departments to effectively implement and maintain Quality Systems.
Qualifications
Bachelor’s Degree in Chemistry, Biology, or other related scientific discipline and minimum two (2) years GMP related experience in biopharmaceutical/pharmaceutical or related industry with direct Quality experience; or equivalent combination of education and experience. Familiarity with pharmaceutical manufacturing processes, 21CFR210/211/820/11.
Please note the company cannot provide immigration-related sponsorship (including H-1B status, O-1 status, Optional Practical Training support, etc.) for this position. Each successful applicant will be required to complete the Form I-9, Employment Eligibility Verification, demonstrating both identity and employment authorization, on or before the first day of employment. Under federal law, only truthful information may be provided on the Form I-9.
Working Conditions
Physical demands may include, but not be limited to, specific vision abilities including near vision/acuity and visual color discrimination.
The work environment may include exposure to a heated/air-conditioned indoor office / manufacturing / cleanroom setting with adequate ventilation and lighting and outdoor environments with varying temperatures. The noise level may vary from quiet to loud. Employees must be willing and able to wear various types of PPE, including, but not limited to, respirators, gloves, safety glasses, and protective clothing, as required by the job to ensure safety in potentially hazardous conditions. Specific cleanroom requirements include employees needing to inform leadership about any health condition that may have an adverse effect on products, as well as compliance with gowning protocols. This means all jewelry, including physically attached items, must not interfere with the effectiveness of personal protective equipment. In addition, all cosmetics, fragranced products (perfumes, aftershave, etc.), and nail products are prohibited, including clear nail polish, artificial nails, and nail extenders.
The company is a radiopharmaceutical manufacturer and radiation may be present in manufacturing and laboratory areas. Employees may be required to be monitored using company provided dosimetry and bioassay testing.
Location
NorthStar Medical Radioisotopes is headquartered in Beloit, Wis. This location is our primary manufacturing site and accommodates all of our corporate functions. Beloit has small city charm, with a lively and renovated downtown, yet is also close to cities such as Madison, Milwaukee, Chicago, and Rockford.
Beloit is a part of the larger South Central Wisconsin/Northern Illinois region, which offers residents and visitors alike a unique blend of urban opportunities and rural, natural beauty. The area, therefore, offers collections of natural, educational, artistic, and historical attractions alongside a wide variety of sporting and social opportunities. There are several cities and many towns within a reasonable commute of Beloit, which offer a wide choice of residential styles and a large number of school district choices for those considering relocation.
NorthStar Medical Radioisotopes is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
