Analyst III, Quality Control

Kincell is seeking a highly motivated QC Analyst III who will be a key contributor to a dynamic and collaborative Quality Control team.

The Quality Control Analyst III 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. This Quality team member 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.
• Lead in execution of raw material testing, stability testing, environmental monitoring, critical utility monitoring, method qualifications, technical transfers, release testing, and method validations.
• Assist in the transfer of assays from the Analytical Development Lab to the QC Lab.
• Demonstrate proficiency in flow cytometric, automated cell counting, dPCR, qPCR, FTIR, ELISA-based, multiplex cytokine detection, pH, endotoxin, and cell-based assays.
• Ensure QC deliverables are met in a timely manner.
• Perform data analysis and review.
• Initiate and 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.
• Train and cross train QC personnel on standard operating lab procedures and test methods.

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
• 4+ 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)
• Strong technical laboratory skills (e.g., pipetting, weighing, and measuring pH)
• Experience with writing standard operating procedures
• An equivalent combination of education and experience may be considered.
• Familiarity with FDA, ICH, and EU Regulations and Guidelines
• Involvement in continuous improvement initiatives and laboratory investigations
• Proficiency in Microsoft Office suite applications

Excellent attention to detail, organizational skills, and ability to multi-task in a dynamic environment.

Preferred:

• 4+ 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

• None

Location

• This is a site-based position in RTP, and it will require some non-standard working hours, including early morning or late evening.

 #LI-Onsite