Quality Control Analyst I (2nd Shift)

FLSA Classification: Non-Exempt/Hourly 

Schedule: Monday to Friday; (Second Shift 12:00pm – 8:30pm); On-site  

Department: Quality Control 

Reports to: Associate Quality Control Manager 

Supervisory responsibilities: No 

Locations: 13203 Murphy Road Stafford TX 77477; UTH – 1941 East Rd. Houston TX 77030   

Position Summary/objective:   

The main role of the Quality Control Analyst I is to execute bio-analytical, cell-based, and/or molecular methods for product release in the Quality Control laboratory.  

Essential functions: 

• Perform release assays for cell product identity and safety, which includes the use of different laboratory methods such as microscopy, visual inspection, cell count & viability, flow cytometry, cell culture, immunoassays, DNA isolation, PCR, sterility, endotoxin, and mycoplasma. 

• Safely handle human biological specimens. 

• Extract, compile, and analyze data.  

• Generate, report, and track results. 

• Conduct and document all activities consistent with cGMP/GxP, regulatory filings, and written procedures. 

• Transport human biological samples between manufacturing facility and QC laboratory. 

• Transport controlled documents between OQS office and QC laboratory. 

• Transport QA-released QC materials between QC laboratories. 

• Manage, in collaboration with other team members, supply inventory.  

• Assist with purchasing, receiving, formulating, testing, and release of materials and reagents. 

• Perform routine equipment maintenance and troubleshooting. 

• Maintain data integrity and logs for equipment.  

Secondary Functions:  

• Assist with quality documents and processes such as GxP deviations, lab investigations, OOS/OOE, CAPAs, change controls, etc. 

• Involved in the creation of systems used in quality control to maintain compliances with regulations 

Competencies: 

• Initiative 

• Problem Solving 

• Very detail oriented 

• Strong analytical, technical writing, verbal communication, and interpersonal skills 

• Ability to work independently and manage multiple projects with aggressive timelines 

Work environment: 

• This position works in a typical office and lab environment with moderate noise levels and uses phone, computer, office equipment and supplies on a regular basis. Other duties performed while outside of office and lab building could involve exposure to manufacturing operations, along with outdoor conditions (including highway traffic) and temperatures. 

• While performing the duties of this job, the employee may be o