Working Title Quality Control Associates I & II - Open Pool Position Location Fort Collins, CO Research Professional Position Yes Posting Number 202000786AP Position Type Admin Professional/ Research Professional Classification Title Number of Vacancies Work Hours/Week Proposed Annual Salary Range $30,000 - $60,000 Salary is commensurate with experience and qualifications Desired Start Date Position End Date (if temporary) To ensure full consideration, applications must be received by 11:59pm (MT) on 03/31/2021 Description of Work Unit
BioMARC is a contract development and manufacturing organization (CDMO) of FDA regulated products. It was created to fill an industry need for higher containment biologic manufacturing. BioMARC is a nonprofit CDMO owned and operated by CSU, and was created to translate and produce biopharmaceutical products 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 scalability issues.
The Quality Control (QC) Associates are responsible for the implementation and execution of policies and procedures to ensure that QC standards are met during production. The position(s) requires escalating levels of experience in executing complicated analytical methods in support of the creation and/or processing of biological production materials. Individual will be working within an FDA compatible Quality System (or similar) using Quality Assurance approved SOPs, protocols and/or similar controlled documents. Candidates must be able to physically perform complex laboratory techniques in rooms that require specialized manufacturing and biocontainment protective gowning and equipment with Biosafety level 3 laboratory entry expected. In addition to cGMP related activities, assay development and execution in support of Non-Clinical production/research support may be assigned with the expectations that the employee make use of skills similar to those described above.
Required Job Qualifications
Applicants must have a Bachelor's degree in the sciences or a a closely related field. Required qualification, rank and salary determined by specific position to be filled.
o Level I is for individuals with a Bachelor's degree and less than 3 years of relevant professional experience OR Bachelor's degree in an unrelated field plus 2 years of professional experience related to the specific assignment or 1 year experience in a contract manufacturing organization.
o Level II is for individuals with a Bachelor's degree and 3 or more years of relevant professional experience OR a Master's degree with no experience OR Bachelor's degree in an unrelated field plus 3 years of professional experience in a contract manufacturing organization
Preferred Job Qualifications
Experience in an analytical, cell biology, or microbiology type laboratory.
Experience in a contract manufacturing or other regulated environment.
Experience in US code of federal regulation fields of GMP,GLP, GXP.
Biosafety Level 3 experience or higher containment facility.
Colorado State University