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Quality Assurance Microbiologist

NorthStar Medical Radioisotopes Beloit, WI
  • Expired: over a month ago. Applications are no longer accepted.

Applicants must be able to work legally within the United States, and we currently do not offer H1B Visa sponsorship. Please, no 3rd party inquiries.

SUMMARY

The Quality Assurance (QA) Microbiologist provides microbiological understanding and oversight for the safe and effective processing of radiopharmaceuticals drugs used to diagnose and treat diseases. Projects and duties will be completed in compliance with applicable cGMP, cGLP, FDA, and all other applicable regulatory agencies standards.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, other duties may be assigned:

  • Review and approve documents in support of any microbiological testing/data performed/generated.
  • Conduct standard microbiological tasks (e.g. identification of microbial agents, preparation of growth media, growth promotion tests, maintenance of microbial cultures, etc.).
  • Conduct tests on radiopharmaceutical manufacturing processes to assess microbiological impact.
  • 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.
  • Environmental monitoring of classified cleanrooms.
  • Support dose audit program.
  • Use of standard microbiology laboratory equipment.
  • Bioburden, Sterility and Bacterial Endotoxin Test (BET) analyses for process samples, including radioactive samples.
  • Sampling and analysis of Water for Injection, Purified water and pure steam condensate including reparation of trends for environmental monitoring and water.
  • Operation of steam sterilizer (autoclave) and dry heat sterilizer (oven).
  • Estimation of total organic carbon from water samples and cleaning samples.
  • Maintain and update laboratory databases track and trend data
  • Provide management with regular progress reports of tests.
  • Perform other quality assurance functions as necessary, with appropriate training.
  • Support NorthStar’s Quality System and Health and Safety Program by following procedures and mentoring others.
  • Effectively communicate safety and quality issues raised by customers or staff in a timely manner.

Ability and willingness to travel up to _20_% of the time between facilities.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

Bachelor’s Degree in Microbiology, Chemistry, Biology or other related scientific discipline and two to five years of related experience in a cGMP environment; or equivalent combination of education and experience.

COMPUTER SKILLS

Experience with Microsoft Office software programs, including Outlook, Word, and Excel.

OTHER QUALIFICATIONS

  • Detail oriented and very organized
  • Strong verbal and written communication skills
  • Ability to prioritize and handle multiple tasks simultaneously
  • Adaptable to change in the work environment
  • Ability to work in a fast-paced environment
  • Ability to work in a team environment, as well as independently

NorthStar Medical Radioisotopes

NorthStar develops, manufactures and distributes radioisotopes that are used daily for patients needing medically important diagnostic imaging tests. Our novel, high technology approaches have enabled NorthStar to be the first company in nearly 30 years to produce the radioisotope Mo-99 in the United States. NorthStar’s processes are non-uranium based and designed to help minimize waste while meeting the highest quality standards. The Mo-99 is used in NorthStar’s RadioGenix® System, an isotope separation platform used by radiopharmacies across the country to produce the imaging radioisotopeTc-99m. NorthStar will scale-up production over the coming months and years and intends to become the industry’s market leader. Beyond Mo-99, we have a pipeline of other novel and medically important isotopes which can further grow our business, and provide development opportunities for our employees. Working with this novel and advanced technology is challenging yet rewarding for talented individuals who want to make a difference and be part of an exciting and rapidly growing business. NorthStar’s people drive our solutions and our success, and we are committed to ensuring that we provide fulfilling work experiences and valuable development opportunities.

Address

1800 Gateway Blvd. Beloit, WI 53511
Beloit, WI
USA

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