Quality Control Analyst I will primarily be responsible for supporting late-phase and commercial quality control activities. This highly motivated member of the Quality Unit will support the organization through the execution of activities such as raw material testing, release testing, stability testing, and environmental monitoring. As part of the Quality operations, you will initiate and assist in investigations and troubleshooting while adhering to cGMP and GDP practices.

Essential Duties and Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.

• Actively participates in fostering a positive, collaborative work culture.
• Authoring and revision of standard operating procedures, test methods, protocols, and reports
• Participate in executing raw material testing, stability testing, environmental monitoring, critical utility monitoring, method qualifications, technical transfers, release testing, and method validations.
• Testing of material utilizing methods such as pH, Osmolality, Appearance, cell culture, bacterial endotoxin, dPCR, ELISA, and other assays used for release and characterization of products.
• Data analysis and review
• Initiate and participate in laboratory investigations, including deviations and out-of-specifications.
• Perform equipment calibrations and analysis of cell viability.
• Participate in the execution of method and equipment troubleshooting and optimization.
• Maintain documentation in accordance with GDP.
• Other duties as assigned.

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.

• S. degree in science or a life science-related field of study
• Experience in Quality Control in a GMP environment, preferably with experience in a microbiology laboratory, is preferred.
• Experience with the following instrumentation: Flow Cytometer (i.e., NC-200), Cell Counter (i.e., NC-200), Hematology Analyzer, Ella
• Proficiency in cell culture of microbiological organisms, operation of microscopes, and equipment calibrations (e.g. pH meters and balances)
• An equivalent combination of education and experience may be considered.
• Strong technical laboratory skills (e.g. pipetting, weighing, and measuring pH)
• Involvement in continuous improvement initiatives and laboratory investigations
• Contract Manufacturing Organization (CMO) or Contract Development and Manufacturing Organization (CDMO) experience desirable.
• Strong technical laboratory skills (e.g., pipetting, weighing, and measuring pH)
• Proficiency in Microsoft Office suite applications.
• Detail-oriented and highly motivated with excellent written and verbal communication skills required.
• Ability to work independently and stay on task in a fast-paced environment without direct supervision.
• Ability to function in a rapidly changing environment and balance multiple priorities simultaneously.

Physical Demands

• Adjusting or moving objects weighing up to 25lbs

Travel Requirements

• 10%

Location

• This is a site-based temporary position located in Durham, NC , and will require some non-standard working hours, including scheduled early mornings, late evenings, and/or weekends.

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