Laboratory Quality Analyst, WF Institute for Regenerative Medicine

Overview

JOB SUMMARY

The Laboratory Quality Analyst will work independently and on team(s) with guidance from senior members of Quality Control or Management. Conducts project related activities for the advancement of cGMP, GTP and GLP-based work conducted at the Wake Forest Institute for Regenerative Medicine (WFIRM).  Performs routine Quality Control testing with some non-routine testing in support of process development activities within the Manufacturing Development Center (MDC). 

EDUCATION/EXPERIENCE

Bachelor’s degree in Biology, Chemistry, Physics, Biomedical Technology, Biomedical Engineering or Medical Laboratory Science and two years’ experience in assay development, hospital or clinical testing in a pharmaceutical, medical device or biologics environment; or, an equivalent combination of education and experience. Familiarity with FDA and/or other regulatory bodies is preferred.

ESSENTIAL FUNCTIONS

1. Assists in the development, implementation and maintenance of quality control systems and activities.
2. May assist in developing standards, methods and procedures for inspecting, testing and evaluating the identity, safety, efficacy and reproducibility of products.
3. Conducts routine and non-routine analysis of developmental, in-process and final products according to Standard Operating Procedures.
4. Operates various laboratory equipment and data collection software such as Flow Cytometers, Biosafety Cabinets, Microscopes and BacT/ALERT 3D Sterility.
5. Assist with or follows basic equipment maintenance and preventative maintenance activities.
6. Learns and assists with environmental monitoring activities to help maintain regulatory requirements for microbial and particulate counts in the cGMP facility.
7. With guidance, may write or revise SOPs to support internal quality control systems, data systems, technical issues and instrumentation.
8. Assists in the maintenance of a controlled environment in the cGMP QC Laboratory setting by cleaning of laboratory equipment and/or performing basic maintenance with guidance or under supervision.
9. If necessary, may serve as backup for product specification reviews and releasing components used within the manufacturing facility.
10. May perform stability and longevity testing for quality assay development, as well as perform testing for clinical manufacturing samples.
11. May troubleshoot equipment and laboratory processes with support.
12. Ensures personal compliance with applicable internal processes and FDA regulations.
13. Potential for weekend work as required to support MDC activities
14. Other duties as assigned.

SKILLS/QUALIFICATIONS

• Strong oral and written communication skills
• Clinical documentation skills
• Good Tissue Practice and Good Laboratory Based Practice regulatory experience.
• Exceptional organizational and record-keeping skills
• Understanding of Microsoft Excel, Word, Teams, and ability to learn other laboratory computer software.
• Outstanding interpersonal skills, high energy and motivated
• General computer skills, including the use of Excel spreadsheets, graphing and statistical programs.

WORK ENVIRONMENT

The Translational Core (TC) is constructed to enable the production of tissue engineered products for evaluation in Phase I/II clinical studies in compliance with the current good manufacturing practice regulations (cGMP) as well as the other applicable regulations for biological products and human cells, tissues, and cell and tissue based products. 

The TC consists of ISO 7 and ISO 8 classified cleanroom space along with an external Quality Control Laboratory and Warehouse.  Access to all classified areas requires appropriate gowning and aseptic techniques. 

May be required to work hours beyond typical 8 a.m.-5 p.m. schedule and/or evenings and weekends as needed.

PHYSICAL REQUIREMENTS

This position requires many hours per month in full cGMP gowning with facemask, hood, and double gloves, within areas of limited mobility, while performing meticulous manual work requiring attention to detail.