Quality-driven team player eager to offer broad scope of Senior Manufacturing Technician, Auditing, and Production Operations experience toward maximizing an employer s success within a growth-oriented role.

 

 

Quality Assurance • Pharmaceutical Manufacturing Operations • Equipment Troubleshooting • Team Training

 

         Top performer who excels at maintaining optimal quality assurance and strong manufacturing performance levels.

         Integral leader who proactively troubleshoots diverse equipment / devices within various high-tech environments.

         Ambitious self-starter who offers superior attention-to-detail and sharp analytical abilities toward meeting goals.

 

 

 

         Utilize broad scope of industry knowledge and dynamic technical acumen toward overseeing bioreactor preparation, buffer preparation, and aseptic sampling, along with troubleshooting state-of-the-art equipment.

         Document data accurately and in real time while overseeing cGMP practices and compliance with controlled documentation (e.g. SOPs, batch records, forms, logbooks), signature controls, and computerized systems.

         Drive operations success by training company technicians to become qualified in Cell Culture.

 

 

         Completed purification of recombinant humanized mono-clonal anti-bodies, including running protein in high affinity chromatography columns, pH adjustment of pools with acids or base for viral inactivation and stability of pool, Tangential Filtration Flow units (TFF) for buffer exchange and concentration of pool prior to freezing.

         Set-up and packed columns for HETP and asymmetry factor analysis, along with efficiently supporting buffer prep encompassing use of pH and condo meters and effectively performing spec scans and sterile sampling techniques.

         Participated within a companywide Operational Excellence team to implement solutions for scheduling of recipes.

         Built and sustained productive operations by troubleshooting malfunctioning equipment to decrease cycle times.

 

 

         Expertly set up, prepared, and operated laser process automation for micro machining micron size holes in plastic films, as well as operating high-power optical equipment and complex machines and following steps without variation.

         Evaluated energy readings and control charts, and sampled and inspected hole diameter and laser adjustments.

         Optimized organizational efficiency by supporting additional manufacturing operations, including aseptic clean room core and non-aseptic dosage, as well as converting clean rooms and secondary packaging operations.

 

 

         Applied sharp analytical abilities toward accurately using and applying cGMPs and SOPs in drug manufacturing.

         Completed comprehensive training as Quality Assurance Designee (QAD) for line sign-off for product changeover.

         Motivated process operators to meet and / or exceed daily goals while maintaining a clean, safe work environment.

         Led production operations as necessary, and trained peers on multiple manufacturing product lines and operations.

 

 

         Developed and created a forward-thinking companywide Quality Systems Manual, including training employees in assembly and manufacturing processes in start-up company phases, as well as directing approval and validation runs.

 

 

         Instrumental in the production of passenger and driver side vehicle air bags and ballistic devices, including implementing Statistical Process Control for tracking product quality to ensure seamless processes at all times.

         Maximized output on production sewing line and exceeded daily objectives while minimizing overall waste.

 

 

Bachelor of Science in Healthcare Administration (In Progress)                                                             University of Phoenix

Associate of Science in Healthcare Administration (In Progress)                                                            University of Phoenix

 

Training in Chromatography Theory I / II • Good Manufacturing Practices • Statistical Process Control