Manager/Sr. Manager/Asso. Dir.-Head of QA,QC-OPEN POOL
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Please see Special Instructions for more details.References will not be contacted without prior notification of candidates.
Posting Detail Information
|Working Title||Manager/Sr. Manager/Asso. Dir.-Head of QA,QC-OPEN POOL|
|Research Professional Position||Yes|
|Position Type||Admin Professional/ Research Professional|
|Number of Vacancies|
|Proposed Annual Salary Range||$65,0000-150,000|
|Desired Start Date|
|Position End Date (if temporary)|
|Open Posting Date|
|Open Until Filled||No|
|To ensure full consideration, applications must be received by 11:59pm (MT) on|
|Description of Work Unit||
BioMARC is a contract manufacturing organization (CMO) of FDA regulated products. It was created to fill an industry need for higher containment biologic manufacturing. BioMARC is a nonprofit CMO 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.
This person is responsible for the design and implementation of policies and procedures at senior operational levels to ensure that GMP quality, control, productions, and team goals and deliverables are met. Relies on extensive experience to maintain and improve a comprehensive systems to support cGMP manufacturing. Managers are responsible for approval of the design and oversight of implementation of policies and procedures to ensure that GMP QC standards, including product release testing, are met during production. Requires an advanced understanding of scientific concepts and have experience in microbial technology and other Bio/pharmaceutical analytical assays. Moreover, it requires advanced levels of experience in communicating (oral and written) in executing quality control assays to support the creation and/or processing of production materials. Employee must work within an FDA recognized GMP Quality System (or similar) using Quality Assurance approved batch cards, SOPs, protocols and/or the like. Continuous self-directed training in the US Code of Federal Regulation fields of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and/or Quality Assurance/Control is required. Must lead and train other staff members and be able to physically perform complex laboratory techniques in rooms that require specialized manufacturing and bio-containment protective gowning and equipment. Entry into Bio-safety level 3 laboratories is likely. Employee must be able to create complex instructions and develop an environment for staff to make professional judgments with regard to compliance, quality and continuous improvement paradigms. Must be able to oversee, investigate and report on incidents and provide intelligent corrective proposals. Senior Management will ensures that appropriate investigations of deviations, CAPA, and OOS’s are performed and completed correctly. This employee will be required to manage audits (internal and external). Will be responsible for interactions with regulatory agencies and represent BioMARC’s to the agency. Must lead other BioMARC personnel. The work involves isolating and defining unknown conditions, resolving critical problems, developing new theories along with the overall planning, developing, and execution of vital programs. The programs are essential to the missions of the overall organization or affect large numbers of people on a long-term or continuing basis.
|Required Job Qualifications||
Bachelors degree in the fields of Science, Engineering, Business, Liberal Arts, or Arts in conjunction with the working requirements listed below.
Research Associate IV is the level to which a Research Associate III is
Senior Research Associate is the level to which a qualified Research
|Preferred Job Qualifications||
Reflecting departmental and institutional values, candidates are expected to have the ability to advance the Department’s commitment to diversity and inclusion.
|Job Duty Category||Primary|
• Oversee Quality Staff: Quality Assurance and/or Quality Control
|Percentage Of Time||80|
|Job Duty Category||Secondary|
• Takes responsibility for maintaining material inventories and equipment qualifications for quality control use. This includes making the right decisions for types of Quality Control grade materials and activities needed to perform regulated quality control functions.
|Percentage Of Time||20|
|Special Instructions to Applicants||
References will not be contacted without prior notification of candidates.
|Conditions of Employment|
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 or expression, or pregnancy and 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/equal access/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. The Office of Equal Opportunity is located in 101 Student Services.
|Background Check Policy Statement||
Colorado State University (CSU) 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. The type of background check conducted varies by position and can include, but is not limited to, criminal (felony and misdemeanor) history, sex offender registry, motor vehicle history, financial history, and/or education verification. Background checks will be conducted when required by law or contract and when, in the discretion of the university, it is reasonable and prudent to do so.
Required fields are indicated with an asterisk (*).
- Cover Letter