Salary commensurate with education and experience.
BioMARC/IDRC/OVPR/CSU This open application pool is a continuous, open-ended advertisement for those candidates interested in applying to one of the job titles listed below. Open positions may not be available at the specific time of your submission; however, once a position becomes available, candidates with documents in the pool will be screened preferentially. Additional information about the applicant pool and how to apply are listed at the end of this document. The jobs covered in this pool include:
LS0052 – Quality Assrnc Spclst I
Job description of the QA Specialist I position:
Under the direction of senior Quality Assurance (QA) staff members, QA Specialist I is responsible for basic QA activities to support the ongoing quality system and cGMP campaign activities. Must be able to review and audit documentation for compliance to good documentation practices and to the technical requirements of directive documents (SOPs, protocols, directive documents, etc.). The QA Specialist I reviews testing, quality control, development study and other reports/data-forms for accuracy, completeness and compliance to requirements to ensure that QA standards and regulatory requirements are met and assist the organization with change control procedures and events. Reviews QA standards, studies existing policies and procedures, and interacts with personnel and clients to evaluate effectiveness of QA program and assists in writing QA policies and procedures. Participates in internal and external audits and assists departments with the coordination of audit information, and recommends appropriate improvement/mitigations. Assists with the monitoring of incidents and CAPAs; supports the mitigation, closure and archiving plans for incidents/CAPAs as well as all other documentation of the organization. Keeps the Director informed of the status of the quality system and unusual occurrences.
Candidates should have knowledge of commonly-used QA concepts, practices, and procedures within cGMP field. Responsible for improving one’s knowledge base of current QA regulations and for informing the Director of any new and/or revised regulations; Relies on instructions and pre-established guidelines to perform the functions of the job, but also have the ability to think critically and work independently. Must have above average communication skills (writing and speaking); responsible for supporting a healthy working environment between other departments where QA is concerned. May oversee personnel engaged in QA support activities. Perform other assigned duties as necessary.
Requires a bachelor's degree and 0-2 years of full-time experience in the field or in a related area
Employment Type: The job title categories within this pool are for positions (when available) that are within a range of 0.5-1.0 Full Time Equivalent (FTE) effort (i.e., 50-100% work effort). Hiring into a particular position at a specific FTE effort is based on the availability of task-specific funds and one’s skill set. Please note that this FTE effort and your salary will be very clearly communicated to you prior to hiring. Continued employment is not guaranteed and is also based on the availability of task-specific funds, one’s skill set and other variables.
Application Deadline: Application Deadline: 1-15-2014. NOTE: This pool will expire in approximately one year (1-15-2014) and individuals will need to reapply to be considered beyond that date.
How to Apply to the Bio/Pharmaceutical Quality Assurance Applicant Pool: Email in PDF form a cover letter addressing your ability to meet the required and desired professional attributes, provide a job specific resume to QualityAssuranceI@colostate.edu. Applications will be accepted on a continuous basis.
The annual Fire and Safety Update and University Drug/Alcohol Policy booklet informs the University Community about important procedures, policies, crime prevention programs and crime statistics. A copy of the booklet may be found online (http://police.colostate.edu/pdfs/2011-Safety-Report.pdf), or a paper copy can be requested by contacting the Colorado State University Police Department at (970) 491-1160.