QC Analyst - Clinical Release and Stability

Insight Global; Malvern (Chester County); On-site; USD 47,733 - 67,984; Full time

Benefits offered by this job

Comprehensive benefits package

401(k) retirement plan eligibility

Paid sick leave

Job summary

A leading staffing agency is seeking a QC CRS Analyst responsible for conducting biochemical and testing of drug materials. This role requires one year of GMP QC experience and a bachelor's degree in biology or chemistry. Key responsibilities include analytical testing, peer reviews, and supporting method validation. The position offers a competitive hourly wage and comprehensive benefits, including medical and 401(k) retirement plan eligibility after 90 days.

Qualifications

• Minimum one year of relevant GMP QC work experience in pharmaceutical lab.
• Proficient in the application of cGMP and GLP regulations.
• Familiarity with analytical technologies in Cell and Gene Therapy Laboratories.

Responsibilities

• Conduct analytical biological testing of drug products.
• Perform peer reviews and approvals of laboratory data.
• Support analytical method qualification and validation.

Skills

GMP QC experience

Flow Cytometry

Microsoft Office proficiency

Analytical testing

Technical document interpretation

Education

Bachelor's degree in biology or chemistry

Job description

The QC CRS Analyst is responsible for conducting biochemical and testing of raw material, in-process, final product release and characterization samples, including CAR-T. They are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations. They typically work with a team of 5 - 10 other Analysts within a functional Clinical Release and Stability Laboratory and report to the Senior QC Supervisor.

Key Responsibilities

• Conduct analytical biological testing of clinical and commercial drug product/drug substance samples
• Perform peer reviews and approvals of laboratory data
• Use electronic systems (LIMS, MES, LES, Empower, etc.) for execution and documentation of testing including application of statistical concepts to laboratory data
• Support of New Product Initiatives (NPI) including owning a project and perform project management functions with limited to no coaching from supervision/management
• Perform Instrument Calibration and Preventative Maintenance
• Update CRS-owned documents using the Document Management System (DMS)
• Order/receive supplies and manage inventory
• Support analytical method qualification, validation, and transfer into and out of the QC lab, owning change control actions, completing testing activities with mentorship from Sr. Analysts on transfer activities
• Complete change control processes to integrate new methodologies and technologies into and out of the CRS Lab with limited oversight
• Act as a peer subject matter expert in assessing talent by participating in panel interviews for job
• Complete invalid assay and general laboratory investigation records
• Complete corrective and preventative actions (CAPA) as assigned
• Assist in the execution of internal audits

Required Skills and Experience

• Minimum one year of relevant GMP QC work experience in pharmaceutical lab
• Bachelor's degree in biology or chemistry
• Working experience in a current Good Manufacturing Practices (cGMP) compliant QC laboratory or equivalent environment and solid understanding of cGMP and current Good Laboratory Practices (GLPs)
• Experience with one or more of the analytical technologies used in the Cell and Gene Therapy Laboratories - specifically with Flow Cytometry
• Ability to read/interpret technical documents such as SOPs, work instructions, test methods and protocols
• Proficient with Microsoft Office applications (Outlook, One Note, Teams, Excel, Word, and PowerPoint)

Compensation

$42.00 / hr

Exact compensation may vary based on several factors, including skills, experience, and education.

Employees in this role will enjoy a comprehensive benefits package starting on day one of employment, including options for medical, dental, and vision insurance. Eligibility to enroll in the 401(k)-retirement plan begins after 90 days of employment. Additionally, employees in this role will have access to paid sick leave and other paid time off benefits as required under the applicable law of the worksite location.