Overview
Quality Control Analyst Jobs in Lakeland, FL at Treatt USA
Job Type: Officer of Administration
Bargaining Unit:
Regular/Temporary: Regular
End Date if Temporary:
Hours Per Week: 35
Standard Work Schedule:
Building:
Salary Range: $88,400 – $115,000
The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University’s good faith and reasonable estimate of the range of possible compensation at the time of posting.
Position Summary
The Columbia Initiative in Cell Engineering and Therapy (CICET) Senior Quality Control (QC) and Analytics Specialist will report to the Associate Director of the CICET Quality Control and Analytics and collaborate with the CICET Process Development (PD)/GMP Manufacturing and research (discovery) teams to develop robust analytical assays required for characterization and perform QC testing of drug substances and clinical-grade drug products, supporting the timely release of cost-effective, GMP compliant, and high-quality cell/ gene therapy products.
Responsibilities
The Senior QC and Analytics specialist will support the set-up and opening of the CICET QC and Analytics laboratory, responsible for the day-to-day laboratory operations and maintenance, assist in the drafting and approval of the Analytics and QC Standard Operating Procedures (SOPs), perform internal Analytical assays and QC testing required for drug product release, characterization, and stability throughout the product development lifecycle, help identify and manage contract testing laboratories (CTL) for assay development and testing, and collaborate with the PD/GMP and Facility Operations teams.
Analytical Method Development and Validation
Assist in developing, qualifying, and validating analytical methods for cell and gene therapy products
Perform internal analytical assays during process development to monitor process (scale-up) and method development
Help identify and manage CTLs to ensure timely turnaround time from sample submission to reporting of assay results
Collaborate with the research and process development teams to transfer biological and molecular assays needed for the development of characterization and release assays and assist in troubleshooting assays
Support continuous improvement of QC workflows to enhance efficiency and assay robustness
Quality Control and Compliance
Conduct internal QC testing and analytics for cell therapy products, including in-process, release, and stability testing
Perform QC assay qualification and validation
Ensure compliance with cGMP regulations, safety protocols, and internal quality standards
Assist in Out-of-Specification (OOS), deviations, and corrective and preventive actions (CAPA) investigations
Documentation and Audit Management
Support the drafting, reviewing, and amending SOPs, specifications, regulatory filings, or other controlled documents in collaboration with QA team
Support regulatory filings and audits by preparing necessary documentation and presenting findings
Assist in all regulatory and internal audits of the facility
Assist in internal and external regulatory audits and inspections as required
Ensure data are promptly captured and recorded according to Good Documentation Practices (GDP) to ensure data integrity and compliance with health agencies’ regulations
Additional Responsibilities
Collaborate with cross-functional teams, including Process Development, Quality Assurance, and Manufacturing, to optimize QC systems
Maintains the Analytics and QC laboratory to ensure efficient day-to-day operations
Assists in training and onboarding Analytics and QC technicians
Minimum Qualifications
Minimum of 4 years of related experience in laboratory facilities and operations management in an academic environment
Bachelor’s degree in Biology, Chemistry, or related field, or equivalent in education and experience
Ability to work independently to complete tasks and collaboratively with multiple teams to execute CICET strategic activities
Experience with Analytical development and QC testing of cell and gene therapy products
At least 4 years of relevant scientific experience in cell/gene and GMP-regulated environment
Strong analytical and problem-solving skills with a detail-oriented approach
Excellent organizational skills and ability to manage multiple priorities
Strong interpersonal and communication skills (written/ verbal)
Working knowledge of computer programs, such as Microsoft Outlook, Word, Excel, PowerPoint, SharePoint, Teams, Adobe Acrobat, Zoom, and data analysis software
Ability to set priorities and exercise sound judgment and initiative
Must possess the ability to handle multiple projects simultaneously and prioritize tasks while maintaining responsibility for timely execution
Strong customer service orientation and skills, with the ability to interact and collaborate positively, constructively, and effectively with multiple stakeholders
Preferred Qualifications
Strongly prefer at least 6 years of relevant scientific experience in cell/gene and GMP-regulated environment
Prefer master’s degree in a relevant scientific discipline or certification in data analytics or related data analysis education, including statistics
Basic knowledge of environmental monitoring practices and clean room operations
Certification in Quality Management Systems (e.g., CQM, CQA)
Other Requirements
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Title: Quality Control Analyst
Company: Treatt USA
Location: Lakeland, FL
