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Posted: 21-Dec-24
Location: Dallas, Texas
Categories:
Internal Number: 24012049
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
- Performs assays and research procedures according to lab standard operating procedures (SOPs).
- Records experimental techniques and data according to laboratory protocol. Calculates accurately test results for statistical purposes. Examines, interprets, compiles and reports result to Principal Investigator.
- Maintains laboratory and equipment according to SOPs. Documents and reports problems to appropriate personnel.
- Participates in lab meetings.
- Teaches lab protocols and safety procedures to other lab members.
- Assists in coordinating technical direction of work to ensure effective and cost-efficient completion of research project.
- Assists with lab administrative duties such as supply requisitioning, scheduling equipment service, distributing work assignments and monitoring expenditures.
- Fulfills continuing education and regulatory requirements related to research performed including safety and compliance training.
KEY SUCCESS FACTORS
- Knowledge of basic lab techniques including pipetting, staining, culture techniques, aliquoting.
- Able to perform basic lab maintenance tasks.
- Knowledge of quality control.
- Knowledge of safety practices related to work performed.
- Skilled in use of computer software related to research needs.
- Able to instruct others in lab and safety protocols.
BENEFITS
Our competitive benefits package includes the following.
- Immediate eligibility for health and welfare benefits
- 401(k) savings plan with dollar-for-dollar match up to 5%
- Tuition Reimbursement
- PTO accrual beginning Day 1
Note: Benefits may vary based upon position type and/or level
QUALIFICATIONS- EDUCATION - Bachelor's
- EXPERIENCE - 4 Years of Experience