Quality Assurance Specialist
Nelson Labs Bozeman, MT
- Expired: over a month ago. Applications are no longer accepted.
BioScience Laboratories was founded in Bozeman, Montana in 1991 by Dr. Daryl Paulson. The author of numerous texts and papers on the subject of antimicrobial testing, Dr. Paulson is known for pioneering the use of statistics in the design, execution, and analysis of efficacy and safety studies. With a commitment to scientific excellence and customer satisfaction, Dr. Paulson has led BioScience Laboratories through several stages of growth while keeping the company firmly planted in the community of Bozeman, where he and his staff enjoy the high quality of life filled with beautiful scenery and nearby outdoor adventures.
Planning for the next twenty years of continued commitment to the antimicrobial testing industry, their clients, and their employees, the company owners, Dr. Paulson and Marsha D. Brown MBA, built a 15,558 square foot laboratory building and a 6,400 square foot administrative building in Bozeman near the campus of Montana State University.
On March 8, 2021, BioScience Laboratories was acquired by Nelson Labs' parent company Sotera Health. Nelson Labs®, a Sotera Health company, is an industry-leading, global provider of laboratory testing and expert advisory services. They perform over 800 rigorous microbiological and analytical laboratory tests across the medical device, pharmaceutical, protective barriers, and tissue industries. They know that every test matters and requires solutions to complex problems to improve patient outcomes and minimize client risk.
DUTIES AND RESPONSIBILITIES
- Schedule audits of in-phase testing in Clinical, In-Vitro, and Virology laboratories, performing as many as time allows, and/or collaborate with other Quality Assurance personnel to perform remaining audits, as necessary;
- Review all raw data associated with Company-testing;
- Proofread Company protocols, final reports, Informed Consents and other study-related materials;
- Assist with internal audits per the internal auditing schedule, including but are not limited to: balance, pipetter and pH meter calibration log books; controlled documents (SOPs and forms); product quarantine; housekeeping records; Autoplate® logbook and maintenance forms; studies in-process files, personnel training files, and ISO process and procedures;
- Assist with scanning and pagination of final reports;
- Type, proofread, and edit QA-related letters, memoranda, and other related materials;
- Assist with the maintenance of the on-site and off-site archive by keeping studies filed in a timely manner and maintaining a current archive master list;
- Assist the Director of Quality Assurance with the maintenance of the controlled documentation system (i.e., master schedule);
- Participate in GLP/GCP training as required; and
- Assume other responsibilities, as agreed with the Director of Quality Assurance.
In addition to the above, Employee will be expected to conduct him/herself in a manner acceptable in a professional business environment, and to adhere to the policies and procedures established in Company's Employee Policy Manual and/or other policies and procedures that Company may adopt from time to time.
- The person who holds this position must have education, training, and experience commensurate with discharging duties and meeting responsibilities specified above.
- Bachelor's degree in a life sciences or microbiology is preferred.
- Good Laboratory and Good Clinical Practice (GLP/GCP) experience Preferred.
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