Manufacturing Associate II/Trainer Resume
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Resume:
SUMMARY
QUALITY ASSURANCE/ TRAINING SPECIALIST with an extensive background in LEAN and SIX SIGMA principles, aseptic technique, quality control, customer relations, and training. My strengths include team building, assessing performance, managing conflict, analyzing data, managing tasks, and developing procedures in high paced clinical and manufacturing environments for start-up and Fortune organizations.
*Communication *Managing Data *Organizing
*Developing people *Managing/Directing *Coordinating
*Orientation * Safety and Compliance *Create Training and (SOP)
documents
*Facilitating cross-functional teams *Validating processes * Team Building and training
PROFESSIONAL EXPERIENCE
Dendreon Corporation, Union City, GA
Cell Manufacturing Associate II/Trainer ()
Executed applicable protocols effecting the manufacturing equipment or environment working with the validation department. Maintained (SOP’s), batch records ,and other applicable documentation. Performed direct manufacturing oversight in the absence of the supervisor and identified and documented process deviations, change controls and corrective actions (CAPA’s).
- Acted as subject matter expert while leading, mentoring, and training other associates in clean room behavior, aseptic process techniques, GMP documentation, quality systems and safety.
- Monitored, coordinated, and executed timely completion of process documentation.
- Created, reviewed, and revised SOP’s and batch records.
- Executed corrective actions and developed innovative ideas for process improvement.
- Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
- Tracked, trended, and reported department specific metrics as requested resulting in continuous improvements of procedures.
QUEST DIAGNOSTICS, Tucker GA -
Forensic Scientist/Trainer (-)
Performed all start up and trouble-shooting functions for the beginning of shift. Performed chain of custody for toxicology assays and calibrated and operated all analyzer machines.
- Trained new staff members on department SOP’s, safety, and procedures..
- Screened, analyzed and interpreted results for certified scientists.
VALTENCIA Y. WILDER, page
Pre-Analytical Technician III/ Team Lead/Trainer (-)
Performed problem resolution on all incoming patient specimen as needed. Performed root cause analysis, and quality control investigation for the department and directed workflow.
- Develop start-up plans including but not limited to a program / project monitoring and communication plan including tracking of milestones and timelines, risk management and action logs. Lead problem solving and resolution efforts in a timely, customer focused manner.
- Trained all employees on their specific job functions (laboratory safety, compliance, S) using Six Sigma and LEAN principles.
- Supervised more than employees at the end of shift in the absence of the supervisor.
- Prepared and presented end of shift reports for middle and upper management on both the local and corporate levels.
- Ensure lessons learned are considered, shared and improvements included in study design process. Oversee the writing of protocol-specific laboratory instruction manuals / participate in the preparation and maintenance of the laboratory specifications document for each protocol within a program as appropriate.
- As required, prepare and present study-specific materials and services to clients. Provide additional training to sponsor, and site personnel as required (telephone training, attendance at training meetings, site refresher meetings, etc.). Participate in external and internal audits as required.
Lab Assistant II/Trainer, -
Processed all incoming patient specimen using aseptic technique. Interpreted and reported results on colon cancer assays. Operated Vitek and Microscan machines.
- Performed department quality control.
- Trained new employees on microbiology and virology assays, equipment usage, and safety.
- Served as department liaison for the Employee Satisfaction Team increasing communication between all levels of management and front line employees.
- Wrote, reviewed, and revised SOP’s.
Medical Technician II/Cell Culture/Trainer -
Initiated and maintained cell lines using aseptic techniques. Seeded plates and tubes for departmental assays. Also performed media prep, Hoechst stains, quality control for department as well as calibrated pipettes and incubators.
- Performed environmental monitoring and particle counts in a level P clean room environment.
- Trained all employees on aseptic techniques and cell culture.
- Wrote, reviewed and revised SOP’s.
- Initiated cross-training throughout the department.
EDUCATION
Howard University
Major: Biology/ Minor: Chemistry
Professional Development
*Process Improvement * Quality Control *LEAN Manufacturing *GMP
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