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