Quality Assurance Associates I, II, or III - Open Pool
Company: Colorado State University
Location: Fort Collins
Posted on: April 19, 2024
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Job Description:
Posting Detail Information
Working TitleQuality Assurance Associates I, II, or III - Open
Pool
Position LocationFort Collins, CO
Work LocationPosition qualifies for hybrid/in-office work
Research Professional PositionYes
Posting Number202301090AP
Position TypeAdmin Professional/ Research Professional
Classification Title
Number of Vacancies
Work Hours/Week
Proposed Annual Salary Range$40,000 - $90,000
Employee Benefits
Colorado State University ( CSU ) is committed to providing
employees with a strong and competitive benefits package that
supports you, your health, and your family. Visit CSU's Human
Resources website for detailed benefit plan information for
permanent full-time and part-time faculty and administrative
professional employees in the following University benefit
areas:https://hr.colostate.edu/hr-community-and-supervisors/benefits/benefits-eligibility/andhttps://hr.colostate.edu/prospective-employees/our-perks/.
Desired Start Date
Position End Date (if temporary)
To ensure full consideration, applications must be received by
11:59pm (MT) on05/31/2024
Description of Work Unit
Founded in 1870, Colorado State University is among the nation's
leading research universities and enrolls approximately 32,000
undergraduate, graduate, and professional students. Located an hour
north of the Denver metro area, Fort Collins is a vibrant community
of approximately 157,000 residents that offers the convenience of a
small town with all the amenities of a large city. Fort Collins is
situated on the Front Range of the Rocky Mountains with views of
14,000 foot peaks, and offers access to numerous cultural,
recreational, and outdoor opportunities.
CSU BioMARC is a nonprofit contract development and manufacturing
organization focused on the production of biopharmaceutical
materials for non-clinical, clinical, and commercial use under
Biosafety Level 2, 3 and Select Agent biosecurity conditions. In
addition to manufacturing and testing services, BioMARC offers
product and process development services, which includes the
creation of development programs focused on implementing cGMP
regulations and biomanufacturing production scalability.
Position Summary
The Quality Assurance Associate is responsible for the
implementation and execution of policies and procedures for the
cGMP manufacturing of biologics. Individuals will be working within
an FDA compatible Quality System using Quality Assurance approved
SOPs, protocols and/or similar controlled documents.
Candidates must be able to physically enter cleanrooms that require
specialized biocontainment protective gowning. Entry and
administrative work is expected in Biosafety Level 2 laboratories
and may be expected in BSL -3 laboratories. In addition, work
related to quality assurance and document control in support of GMP
manufacturing, testing, and Non-Clinical production/research may be
assigned with the expectations that the employee make use of skills
similar to those described above. Successful candidates must be
able to perform as part of a team and think critically through
instructions, problem solve and make professional judgments with
regard to regulatory compliance, quality and continuous improvement
paradigms.
The different position level(s) require escalating levels of
experience in the understanding and application of scientific
concepts and experience in a Biopharmaceutical manufacturing
environment.
Required Job Qualifications
Required qualification, rank and salary determined by specific
position to be filled.
Minimum Qualifications:
Level Iis for individuals with a Bachelor's degree in biology,
chemistry, or related science, OR a Bachelor's degree in an
unrelated field plus 1 year of professional experience related to
the specific assignment or 1 year experience in a contract
manufacturing organization.
Level IIis for individuals with a Bachelor's degree in biology,
chemistry, or related science and 2 or more years of relevant
professional experience, OR a Master's degree with no experience,
OR a Bachelor's degree in an unrelated field plus 3 years of
professional experience in a contract manufacturing
organization.
Level III is for individuals with a Bachelor's degree in biology,
chemistry, or related science and 4 or more years of relevant
professional experience, OR a Master's degree with 2 years
experience, OR a Bachelor's degree in an unrelated field plus 5
years of professional experience in a contract manufacturing
organization.
The successful candidate must be legally eligible to work in the
U.S. at time of application; the Infectious Disease Research Center
will not provide visa sponsorship for these positions.
Preferred Job Qualifications
Relative experience commensurate with the specific position to be
filled in a GMP quality system or document control.
Relative experience commensurate with the specific position to be
filled in a contract manufacturing or other regulated
environment.
Relative experience commensurate with the specific position to be
filled in US code of federal regulation fields of GMP , GLP ,
and/or GXP .
Biosafety Level 2/3/or working in high containment facility.
Diversity Statement
Reflecting departmental and institutional values, candidates are
expected to have the ability to advance the Department's commitment
to diversity and inclusion.
Essential Duties
Application Details
Special Instructions to Applicants
Please submit a resume/CV, a cover letter outlining your areas of
expertise, and the names and contact info of three professional
references.
References will not be contacted without prior notifications of
candidates.
The pool is valid through 05/31/2024. Individuals wishing to be
considered beyond this date must reapply.
Conditions of EmploymentPre-employment Criminal Background Check
(required for new hires)
Search ContactDarragh Heaslip, Darragh.Heaslip@colostate.edu
EEO Statement
Colorado State University is committed to providing an environment
that is free from discrimination and harassment based on race, age,
creed, color, religion, national origin or ancestry, sex, gender,
disability, veteran status, genetic information, sexual
orientation, gender identity/expression, or pregnancy in its
employment, programs, services and activities, and admissions, and,
in certain circumstances, marriage to a co-worker. The University
will not discharge or in any other manner discriminate against
employees or applicants because they have inquired about,
discussed, or disclosed their own pay or the pay of another
employee or applicant. Colorado State University is an equal
opportunity and equal access institution and affirmative action
employer fully committed to achieving a diverse workforce and
complies with all Federal and Colorado State laws, regulations, and
executive orders regarding non-discrimination and affirmative
action. TheOffice of Equal Opportunity (https://oeo.colostate.edu/)
is located in 101 Student Services.
The Title IX Coordinator is the Director of the Office of Title IX
Programs and Gender Equity, 123 Student Services Building, Fort
Collins, CO 80523-0160, (970) 491-1715,titleix@colostate.edu.
The Section 504 and ADA Coordinator is the Director of the Office
of Equal Opportunity, 101 Student Services Building, Fort Collins,
CO 80523-0160, (970) 491-5836,oeo@colostate.edu.
The Coordinator for any other forms of misconduct prohibited by the
University's Policy on Discrimination and Harassment is the Vice
President for Equity, Equal Opportunity and Title IX, 101 Student
Services Building, Fort Collins, Co. 80523-0160, (970)
491-5836,oeo@colostate.edu.
Any person may report sex discrimination under Title IX to
theOffice of Civil Rights, Department of Education
(https://www2.ed.gov/about/offices/list/ocr/docs/howto.html) .
Background Check Policy Statement
Colorado State University strives to provide a safe study, work,
and living environment for its faculty, staff, volunteers and
students. To support this environment and comply with applicable
laws and regulations, CSU conducts background checks for the
finalist before a final offer. The type of background check
conducted varies by position and can include, but is not limited
to, criminal history, sex offender registry, motor vehicle history,
financial history, and/or education verification. Background checks
will also be conducted when required by law or contract and when,
in the discretion of the University, it is reasonable and prudent
to do so.
References Requested
References Requested
Minimum Requested3
Maximum Requested3
Supplemental Questions
Required fields are indicated with an asterisk (*).
Applicant Documents
Required Documents
Resume or CV
Cover Letter
Optional Documents
Keywords: Colorado State University, Fort Collins , Quality Assurance Associates I, II, or III - Open Pool, Other , Fort Collins, Colorado
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