What are the responsibilities and job description for the Submission for the position: Research Assistant III position at Baylor Scott & White Healthcare?
Research Assistant III
Dallas, TX
Schedule : M-F 8a- 5p (some weekend and Holidays depending on process)
The cGMP QC Technician reports to the cGMP Manager, and the QC Supervisor. Once fully trained, this individual will have the ability to work independently while performing specialized techniques in an FDA-regulated cGMP Core Lab. The primary job will be reagent / supply ordering & test cellular based products for quality and ship investigational cellular products for therapeutic use in human phase I clinical trials The cGMP QC Technician assures all activities in the lab complies with Federal, State and local regulations and policies.
CORE FUNCTIONS Quality Control
- Performs specialized quality tests on manufactured products for use in human phase I clinical trials.
- Performs new method development & qualification as needed.
- Creates SOPS, lab forms as needed.
- Assists in the release of manufactured products to clinic.
- Assists QC during environmental monitoring activities.
- Assists in inventory check-in, documentation, and proper storage of reagents. To maintain adequate materials and reagents used for manufacturing and quality testing of cellular products using in human phase I clinical trials.
- Prioritizes and adjusts workflow and schedules to meet demands of multiple projects, and assure that necessary supplies are available.
- Ensures all activities in the lab comply with federal, state, and local regulations and policies.
- Responsible for laboratory records, equipment records, materials check-in records and all quality documents related to job function while adhering to cGMP, GLP and GDP.
- Assists in inventory check-in, documentation, and proper storage of reagents.
- Assists with revalidating existing analytical methods and procedures.
- Involves working long hours in a clean room with restrictive gowning.
- Assume other job duties as assigned. Cross training as a Manufacturing technician may also occur, however those activities will be separated from any manufacturing responsibilities so that these duties will not overlap and will follow the Manufacturing technician job responsibilities.
JOB SUMMARY
The Research Assistant 3 performs various laboratory procedures, basic research, lab maintenance and administrative duties under the direction of a Principal Investigator; and trains and oversees less experienced personnel.
ESSENTIAL FUNCTIONS OF THE ROLE
KEY SUCCESS FACTORS
BENEFITS
Our competitive benefits package includes the following.
Note : Benefits may vary based upon position type and / or level
QUALIFICATIONS
