Senior Training Specialist - 2nd Shift

FLSA Classification: Exempt/Salary 

Schedule: Monday-Friday (On-Site), 1230-2100; Weekends/Holidays, as needed. 

Fully onsite- eligible for up to 1-day work from home per week, but not on a regular basis, depending on business need and performance. 

Department: Chemistry, Manufacturing, and Controls (CMC) 

Reports to: Training Manager, CMC-GMP 

Supervisory responsibilities: No 

Location(s):  

• 13203 Murphy Road, Suite 100, Stafford, Texas 77477- Weatherford Building 

• 1941 East Road, BBSB 6102, Houston, Texas 77054- University of Texas Health Science Center 

Position Summary/objective: 

The primary purpose of the position is to provide classroom, hands on aseptic and technical training, and coaching for new and existing CMC-GMP personnel. 

Essential functions: 

• Facilitates GMP onboarding and training activities for Manufacturing Associate personnel including but not limited to sterile gowning, aseptic processing, and good documentation practices. 

• Performs GMP facility specific training including observation and hands-on activities. 

• Maintains accurate documentation of training activities. 

• Participates in the creation and review of SOPs and Working Instruction documents. 

• Functions as a subject matter expert for all critical manufacturing equipment and software. 

• Assess trainee competency and provide feedback to trainee and Manager. 

• Liaison with Manager to identify technical training needs and expectations. Monitor and share progress and outcomes. 

• Assess training programs for continuous improvement, error reduction, and increased operator aseptic and process knowledge and skill. 

• Support investigations, CAPAs, and change controls related to training. 

• Trains CMC-GMP personnel on patient PBMC isolations in support of immunomonitoring assays. 

• Maintains reagents and supply inventory for training activities. 

• Maintains annual sterile gowning qualification.   

Secondary functions: 

• Provide on-site guidance to personnel during routine production process according to SOPs, BRs, and facility requirements. 

• Authors and reviews SOPs, Working Instruction, and Batch Record documents and maintains accurate documentation in compliance with FDA’s Good Laboratory Practices, Good Manufacturing Practices, and Good Tissue practices regulations as well as standards set by other accreditation agencies including but not limited to FACT, CAP, and CLIA.  

• Relays relevant training updates to all Manufacturing Associates. 

• Provide training to trainees in both classroom and Manufacturing floor settings. 

Competencies: 

• Independent Working- minimal supervision of routine tasks; limited supervision of non-sta