- Review and approve documents in support of any quality control testing, batch release testing, and annual stability testing/data performed or generated.
- Hire, manage, and develop QC personnel to ensure compliance with the applicable regulations.
- Provide onsite support during production runs/manufacturing of radioisotopes and final drug product.
- Liaise with Microbiologists and QC personnel at other sites to ensure consistent application of microbiology methods and procedures for GMP laboratory testing.
- Prepare and provide monthly QC quality performance metrics to Senior Management.
- Supervise standard microbiological tasks (e.g. identification of microbial agents, preparation of growth media, growth promotion tests, maintenance of microbial cultures, etc.).
- Familiar with analytical instrumentation used in the Radiation Laboratory
- Maintain laboratory procedures in accordance with Good Laboratory/Manufacturing Practice standards of the US FDA, 21 CFR Part 210 & 211.
- Execute internal and external audits as needed.
- Assist in the creation of Standard Operating Procedures, protocols, and reports.
- Develop and validate laboratory procedures within the department and comply with cGMP in all areas of the business.
- Initiate and approve non-conforming materials reports (NCMRs), investigate deviations, laboratory out-of-specification (OOS), and CAPA investigations. Perform risk assessments, participate in root cause analysis investigations, tracking, follow-up, and reporting/trending.
- Supervise environmental monitoring of ISO-controlled spaces in accordance with all applicable standards.
- Familiar with the use of standard microbiology laboratory equipment.
- Familiar with Bioburden, Sterility, and Bacterial Endotoxin Test (BET) analyses for process samples, including radioactive samples.
- Serve as the subject matter expert in certain areas of Quality Control and analytical instrumentation.
- Maintain and update laboratory databases to track and trend data.
- Provide on-the-floor QC oversight of manufacturing operations.
- Perform other quality functions as necessary, with appropriate training.
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Manager, Quality Control - Beloit, United States - NorthStar Medical Radioisotopes LLC
Description
Overview:
Are you looking to be part of a game-changing organization that has the potential to help cure cancer? NorthStar Medical Radioisotopes is seeking individuals with a pro-active, collaborative, can-do mindset to join our rapidly growing team.
NorthStar Medical Radioisotopes is a growing, commercial-stage company focused on advancing patient care by providing therapeutic radioisotopes and novel radiopharmaceuticals to detect and treat cancer, and customized radiopharmaceutical development services.
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, and all NorthStar employees are eligible on day one for our annual bonus and equity incentive plans.
Position:The Manager, Quality Control (QC) provides microbiological, chemical, and radiological understanding and oversight for the safe and effective processing of radiopharmaceutical drugs used to diagnose and treat diseases. The Manager, QC will provide quality control oversight and direction from incoming material inspection and through product release. Projects and duties will be completed in compliance with applicable cGMP, cGLP, FDA, and all other applicable regulatory agencies standards.
This position supports production in a 24-hour manufacturing facility and may require evenings, nights, weekends, and some holidays with occasional overtime.
Responsibilities:Minimimum Qualifications:
Bachelors Degree in Microbiology, Biology, or other related scientific discipline and minimum six (6) years of progressive experience in the medical device or pharmaceutical industry and a minimum of two (2) years of management experience; or equivalent combination of education and experience. Experience working directly with regulatory agencies, sound knowledge of applicable portions of agency guidance, and regulations (21CFR Part 210/211/820 and ISO
Preferred Qualifications:
Completion of an accredited Nuclear Medicine Technology educational program. Knowledge of ALARA principles, operating radiation detection equipment, and handling of radioactive materials preferred. Understanding of pharmaceutical manufacturing processes, 21 CFR 210/211/820.
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.
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.
