The Quality Control Analyst II will primarily be responsible for supporting and leading early/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 be responsible for initiating and assisting 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.

Essential Duties and Responsibilities

• Actively participate in fostering a positive, collaborative work culture.
• Author and revise standard operating procedures, test methods, protocols, and reports.
• Perform execution of 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.
• Ensure QC deliverables are met in a timely manner.
• Perform data analysis and review.
• Participate in laboratory investigations including deviations and out of specifications.
• Perform equipment calibrations.
• Execute method and equipment troubleshooting and optimization, as needed.
• 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.

Required:

• S. degree in science or a life science-related field of study
• 2+ years’ experience in Quality Control in a GMP environment
• Proficiency in eukaryotic cell culture, molecular techniques, operation of microscopes, and equipment calibrations (e.g., pH meters and balances)
• An equivalent combination of education and experience may be considered.
• Strong organizational and analytical skills; able to prioritize and manage multiple complex processes/projects.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Experience with writing standard operating procedures
• Familiarity with FDA, ICH, and EU Regulations and Guidelines
• Contract Manufacturing Organization (CMO) or Contract Development and Manufacturing Organization (CDMO) experience desirable.
• Involvement in continuous improvement initiatives and laboratory investigations
• Proficiency in Microsoft Office suite applications

Preferred:

• 2+ years’ experience in Quality Control in a GMP environment, preferably with experience in a microbiology laboratory
• Experience with the following instrumentation: flow cytometers, qPCR, digital PCR, multimode plate readers

Travel Requirements

• N/A

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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