Biopharma Quality Control Supervisor/Associate
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 open application pool is a continuous, year-long advertisement for those candidates interested in applying to the Production Supervisors/Associates pool. Open positions may not be available at the specific time of your submission; however, once a position becomes available, candidates in the pool will be screened.
Under the supervision of Quality Control (QC) Manager, the QC Supervisor/Associate is responsible for the implementation of policies and procedures to ensure that QC standards are met during production. It requires escalating levels of experience in executing complicated batch production records for the creation and/or processing of production materials. QC Associates must be able work within an FDA recognized 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 expected. Employees will physically perform complex laboratory techniques in rooms that require specialized manufacturing and bio-containment protective gowning and equipment. Entry into Biosafety level 3 laboratories is likely. Employees will think critically through instructions and make professional judgments with regard to compliance, quality and continuous improvement paradigms. Employees will investigate and report on incidents and provide intelligent corrective proposals. May provide support services to Method Development or Pre-Clinical Production projects using similar techniques to above.
Required Job Qualifications
Research Associate I:
- 0-3 years of professional experience
- Bachelor’s degree in the science’s or related field
Research Associate II:
- +3 years of professional experience
- Bachelor’s degree in the science’s or related field
- Master’s degree in the sciences or related field
Research Associate III:
- +5 years professional experience
- Bachelor’s degree in the sciences
- +2 years professional experience
- Master’s degree in the sciences
- PhD in the sciences
Preferred Job Qualifications
- Preferred degree from one of the following areas: microbiology, biotechnology, cell biology, biochemistry, chemical/biomedical engineering, pharmacology, or related field.
- Experiences 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 high containment facility
- Experience in microbiology or cell biology type laboratory.
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 Quality Control Duty/Responsibility
- Create/implement/execute written procedures for the evaluation of raw materials, in-process samples and finished product with a high degree of precision and accuracy.
- Perform a variety of simple and complex (bio)analytical tests using complex quantitative and qualitative analysis, summarize findings, perform risk analysis, and chart corrective actions (where applicable). Examples: cell culture, protein purifications, DNA/RNA manipulations, immunohistochemistry, etc.
- Complete sophisticated documentation requirements for all GMP activities following Good Documentation Practices (GDP). Must be able to justify all written records to Regulatory Auditors (e.g., FDA) in person.
- Independently analyze complex quality control data sets, summarize findings, perform risk analysis, and chart corrective actions. Must consistently exercise discretion and judgment to meet quality control standards in GMP environment.
- Support in the creation of controlled documents such as specification sheets, protocols, reports, SOPs and other directive documents.
- Support the clean room maintenance of the production and support rooms. This involves the physical cleaning of floors, walls, ceilings, equipment and other surface areas. Must analyze microbial flora results and respond to contaminant alert levels.
- Prepare buffers, solvent solutions, and microbial media for scientific use.
Percentage Of Time 60 Job Duty Category Environmental Monitoring Duty/Responsibility
- Perform environmental monitoring for GMP classified rooms.
- Provide reports regarding the environmental state of all GMP classified rooms.
- Coordinate with cleaning teams to ensure all GMP rooms are maintained a level that satisfies GMP room requirements.
Percentage Of Time 20 Job Duty Category Administrative Duty/Responsibility
- Supervise other QC staff members.
- 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.
- Required to manage and record non-batch card laboratory activities daily in project-specific laboratory notebooks under GDP.
- Perform other duties as required.
Percentage Of Time 20
Special Instructions to Applicants
Special Instructions Summary
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); Not to drop below the U.S. Fair Standard Labor Act dollar value thresholds for exempt employees. Hiring into a particular position at a specific FTE effort is based on the availability of task-specific funds, one’s skill set and other variables. 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.
- Applications will be accepted on a continuous basis. Candidates are likely to be selected prior to the closing date.
- This open pool will expire on 02/01/19 and individuals will need to reapply to any new opening to be considered beyond that date.
References will not be contacted without prior notification of candidates.
Conditions of Employment
Pre-employment Criminal Background Check (required for new hires)
Search Contact BioMARCJobs@colostate.edu
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.
The Title IX Coordinator is the Executive Director of the Office of Support and Safety Assessment, 123 Student Services Building, Fort Collins, CO 80523 -2026, (970) 491-7407.
The Section 504 and ADA Coordinator is the Executive Director of Human Resources and Equal Opportunity, Office of Equal Opportunity, 101 Student Services Building, Fort Collins, CO 80523-0160, (970) 491-5836.
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.