Nyomi Sharkey
San Diego
Summary
Results-driven manufacturing professional with a strong background at Biolinq Incorporated, excelling in process optimization and GMP compliance. Proven ability to lead teams, enhance productivity, and implement effective training programs. Skilled in documentation and inventory management, demonstrating exceptional attention to detail and problem-solving capabilities in fast-paced environments. Recognized for high productivity and ability to complete tasks swiftly. Possess specialized skills in quality control, machinery operation, and safety protocols that ensure consistent excellence in production environments. Excel in team collaboration, problem-solving, and adaptability, bringing valuable soft skills to optimize manufacturing processes and outcomes.
Overview
19
19
years of professional experience
Work History
Manufacturing Associate III
Biolinq Incroporated
San Diego
11.2023 - Current
- Maintained clean, organized work areas per 5S to ensure safety compliance.
- Followed standard operating procedures for effective quality control.
- Conducted routine inspections for defects in manufactured products.
- Participated in team briefing to discuss workflow improvements and safety practices.
- Documented daily production activities, maintained inventory of raw materials, subassembly and logs accurately.
- Escalated manufacturing issues to management and quality assurance.
- Completed and reviewed GMP documentation, driving traceability of development, manufacturing and testing activities.
- Assist in the development of new production techniques or processes aimed at increasing productivity levels.
- Adhered to current good manufacturing practices to support proper design, monitoring, and control of manufacturing processes and facilities.
- Followed detailed assembly instructions, processes, and procedures for product assembly.
Manufacturing/Production Support Team Lead
Organogenesis Inc.
La Jolla
01.2011 - 11.2017
- Provided leadership and direction to nine production support team members.
- Collaborated with upper management to achieve short-term and long-term company objectives.
- Established clear goals and deadlines for daily operations, monitoring team performance.
- Trained teams on setup, usage, and troubleshooting of custom manufacturing equipment.
- Ensured strict adherence to aseptic processing techniques and proper product labeling.
- Conducted weekly inventory assessments in production, manufacturing, and packaging areas.
- Educated operators on job procedures, safety practices, and equipment operations.
- Assisted various departments with daily needs and special requests.
Operator
Dexcom, Inc.
San Diego
01.2007 - 01.2011
- Company Overview: Dexcom, Inc. is a company that develops, manufactures, and distributes continuous glucose monitoring systems for diabetes management. Website: https://www.dexcom.com
- Knowledge of testing, documentation of SOPs, safety procedures, clean room, R&D laboratory control, inventory management, inspections and packaging.
- Audit processes while being performed to ensure compliance of SOPs, MPIs, TPs, etc. and to perform retraining when necessary.
- Experienced in parts and process controls, component bonding (UV and adhesive), circuit board soldering, disordering, and wire wrapping.
- Managed assemblies; including mechanical, testing, calibration, handling of extremely small delicate components.
- Daily set up and shut down production equipment such as plasma stations, ISOPStat lines, etc.
- Routinely monitor production equipment. Adjust equipment setting parameters to optimize equipment performance.
- Trouble-shoot, repair and test production equipment.
- Assemble, test and maintain fixtures, modules, and replacement parts.
- Assist and conduct equipment IQs, minor PMs, and calibrations.
- Update equipment records in RAM or other record keeping system.
- Assist equipment/parts ordering, receiving and locating to the designated area.
- Dexcom, Inc. is a company that develops, manufactures, and distributes continuous glucose monitoring systems for diabetes management. Website: https://www.dexcom.com
Education
College -
San Diego City College
San Diego, CA01.2001
High School -
Samuel F.B. Morse High School
San Diego, CA01.1999
Skills
- Process optimization and workflow improvement
- GMP compliance and safety practices
- Production documentation and inventory management
- Effective communication and attention to detail
- Training coordination and team leadership
- Aseptic processing and troubleshooting techniques
- Problem solving
- Adaptable learner
- Organizational skills
- Documentation
- Strong work ethic
- Record keeping
- Goal setting
- Task prioritization
- Reading comprehension
- Good communication
- Manufacturing environments
Timeline
Manufacturing Associate III
Biolinq Incroporated
11.2023 - Current
Manufacturing/Production Support Team Lead
Organogenesis Inc.
01.2011 - 11.2017
Operator
Dexcom, Inc.
01.2007 - 01.2011
College -
San Diego City College
High School -
Samuel F.B. Morse High School