The Quality Assurance Manager works with operations, manufacturing, and clinical personnel to assure the creation, training, implementation and adherence to the quality policies of the Nebraska Nanomedicine Production Plant (NNPP). The Quality Assurance Manager works with the NNPP senior management to develop training policies and programs for NNPP and related personnel. Position Details Additional Information Posting Category Research - Non Academic Working Title Manager, Quality Assurance (Part-Time) Job Title Research/Ag Specialist Salary Grade RA25S Appointment Type B1 - REG MGR PROF SALARY Salary Range $34,750 - $55,600/annual Job Requisition Begin Date 12/21/2021 Required Education: Bachelor's degree
If any degree major/training is required, please specify the type. (NOTE: Concentration and minors are not equivalent to a major)
Pharmaceuticals, Biotechnology, Engineering or related field (Will consider a Master’s in related field with one year required experience)
Required Experience 3 years
If any experience is required, please specify what kind of experience:
Experience with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Quality Systems Management
(Will consider a Master’s in related field with one year required experience)
Required License No
If yes, what is the required licensure/certification?
Required Computer Applications: Microsoft Excel, Microsoft Word, Microsoft Outlook
Required Other Computer Applications:
Required Additional Knowledge, Skills and Abilities: Knowledge of GMP manufacturing, GCP, clinical trials, GDP and GLPComputer data entry and database management skillsAdvanced communication and organizational skillsAdvanced interpersonal skills and the ability to work with individuals across all organizational levelsAttention to detail and accuracyAbility to read, analyze, and interpret technical procedures and/or governmental regulationsOccasional travel to obtain training/certification at a national professional meeting (e.g. Regulatory Affairs Professionals Society (RAPS); once per year). Any travel will be reimbursed in accordance with University policy.
Preferred Education: Master's degree
If any degree/training is preferred, please specify the type:
Education and experience in federal regulations, pharmaceuticals, and quality systems management
Preferred Experience:
Pharmaceutical manufacturing, Nanomedicine production, CGMP and CGLP regulations, Standard Operating Procedures and Primary governance documents, FDA inspections and regulations
Preferred License: No
If yes, what is the preferred licensure/certification?:
Preferred Computer Applications: Not Applicable
Preferred Other Computer Applications: ISA (Investigation/Study/Assay) isaConfigurator, isaCreator, isaValidator
Preferred Additional Knowledge, Skills and Abilities:
Email to a Friend https://unmc.peopleadmin.com/postings/51941
EEO Statement EEO Statement
The University of Nebraska Medical Center (UNMC) is committed to creating a diverse and inclusive work and learning environment free from discrimination and harassment. UNMC is dedicated to creating an environment where everyone feels valued, respected and included. UNMC does not discriminate based on race, color, ethnicity, national origin, sex, pregnancy, sexual orientation, gender identity, religion, disability, age, genetic information, veteran status, marital status, and/or political affiliation in its programs, activities, or employment. UNMC complies with all local, state and federal laws prohibiting discrimination, including Title IX, which prohibits discrimination on the basis of sex.