QC Analyst

Job Description

Duties and Responsibilities:

Sterility and Bioburden Testing:

• Ability to execute Sterility Testing using the BACT Alert Sterility System.
• Ability to execute Bioburden testing using the BACT Alert System.
• Develop and execute analytical validations sterility and bioburden.
• Assist in the development of analytical procedures to support sterility and bioburden testing.

Release and Stability Testing:

• Familiar with Flow Cytometry, PCR, and Endotoxin testing.
• Execute testing procedures for patient products manufactured, report results using GDP in a timely fashion and maintain in the batch record.
• Execute testing on stability programs. Generate results and document findings.
• Provide guidance to other employees on QC testing and techniques.
• Responsible for training and mentoring new employees on QC process and analytical methods.

Analytical Development:

• Review current validations for appropriateness to current standards and requirements.
• Execute analytical validations as needed i.e. change in analysis to meet FDA requirements, establishment of a new site protocol requiring new testing.
• Assist in review of analytical data.
• Perform statistical analysis of results.
• Manage the Quality Control requirements for the onboarding of new products.
• Work with manufacturing lead to help bring new products to the facility.
• Coordinate all Quality Control needs, method development, validation, SOP generation, material acquisition.
• Investigation of existing technology to determine feasibility for new products when needed.
• Develop the sites understanding on testing methods.
• Author, review and revise forms, job aids, policies and Standard Operating Procedures.
• Participate in 5 hours of continuing education annually – in cellular therapy or quality topics.
• Responsibilities may be modified or added as needed and discussed with the appropriate management feedback.

Education & Experience:

• BS with 1+ year of Pharma/Biotech experience.