Omar Aden
Quality & Regulatory Profession
San Diego,CA
Summary
Detail-focused, highly-motivated with extensive experience in overseeing quality control, quality inspection and quality assurance with desire to take on new challenges. Strong work ethic, adaptability, and exceptional interpersonal skills.
Skills
- Strong Quality understanding of medical device regulations requirements, (eg FDA 21 CFR 820, ISO 13485:2016)
- Experience with FDA PMA, 510(k) submissions
- ISO/USP Standards/cGMP
- Quality Assurance for FDA/ICH Compliances
- QA/QC/MDSAP/Internal Audits
- Change Control/Compliance
- Cross-functional team leadership obtaining maximum performance in a timely manner
- QA Documentation Review
- Quality control tests
- Personnel Training
- New Project Design/Development/Project Control
- Analytical Methods Development/Validation
- Purification process development, including HPLC/UPLC, ELISA, SDS-PAGE, Western Blot and Spectroscopy
- Operation of HPLC, GC, LC/MS and diverse lab equipment
- Project Planning and Scheduling
- Process Improvements
- Strong interpersonal skills
- Ability to work in a fast-paced environment with high quality outcomes
- Environmental Health and Safety (EHS)
- Knowledge of Standard for Electrical Safety in the Workplace (NFPA 70E)
- Handling employee safety issues
- Safety Standards Compliance
- Safety and OSHA compliance
- Data Analytics
- Quality Systems
- Warehousing functions
- Operations Planning
- ISO Environmental Monitoring & Trending
- Waste Management
- Stormwater Management
Overview
19
19
years of professional experience
Work History
Sr. Manager, Quality and EH&S
Suneva Medical, Inc., part of Tiger Aesthetics
San Diego, CA
01.2020 - Current
- Company Overview: (formerly Artes Medical, Inc.), San Diego, CA.
- Direct and coordinate department activities to ensure achievement of company objectives, as well as resolve problems.
- Work with other departments to accomplish the same.
- Supervise QC and QA Inspection staff, including coaching and developing to enable maximum performance and individual employee growth. Provides regular performance review and feedback and uses corrective action as necessary.
- Collaborate with R&D teams to establish quality criteria for new products, ensuring design for quality and manufacturability.
- Provide technical guidance to Regulatory team members on issues related to QC testing and validations.
- Handle Environmental Health and Safety (EH&S), in addition to Sr. Manager of Quality.
- Ensure compliance with health and safety regulations, as well as company policies and procedures according to OSHA, laboratory cleanliness, and orderliness.
- Developing strategies and plans to reduce injuries, illnesses, property damage, and environmental harm.
- Respond to and investigate incidents and injuries in the workplace.
- Preparing and scheduling training for employees on topics such as emergency procedures and workplace safety
- Oversee the handling of hazardous materials on site.
- Manage the approved supplier list (ASL) for compliance. Negotiate with suppliers and vendors to improve product quality, reduce testing costs, and ensure timely delivery of materials.
- Ensure compliance with ISO/USP standards and other regulatory requirements related to stability studies and lot release requirements.
- Conduct root cause analysis to identify defects in a timely manner.
- Help manage the maintenance of quality management systems (QMS), ensuring continuous improvement and efficiency.
- Review and update quality assurance policies and procedures.
- Oversee the interviewing/hiring process for new department employees.
- Responsible for providing high-level chemistry testing support for raw materials, in-process, and finished product release/stability testing, and for basic method development/validation.
- Provide support for environmental monitoring of ISO 5, 6, 7, and 8 cleanrooms, including environmental water testing and quarterly reporting.
- Manage stability program and stability data analysis. Conduct historical data trending and related documentation, generate release/stability tracking charts, and OOS tracking charts.
- Support test method, process, and software validation activities, as well as support document control and internal quality auditing requirements.
- Analyze and monitor department costs.
Manager, Quality Control
Suneva Medical, Inc.
San Diego, CA
04.2017 - 12.2019
- Company Overview: (formerly Artes Medical, Inc.), San Diego, CA.
- Ensured compliance with current Good Manufacturing Practices (cGMP), Code of Federal Regulations (21 CFR 820), and ISO 13485 standards.
- Cross-trained employees on additional job positions to maintain coverage of roles.
- Recruited and hired qualified candidates to fill open positions.
- Held regular one-on-one meetings with employees to review performance and priorities and provide feedback.
- Decreased outsourcing, lot release, and sterility testing by 60% (from $100k/year to $60k/year).
- Replaced outdated HPLC with UPLC, decreasing sample test run time from 18 hours to less than 2 hours.
- Supported and responsible for authoring and revising SOPs for test method validations, equipment use and maintenance, and other laboratory functions.
- Supported aseptic environmental monitoring of filling operations and routine operations, while conducting sterile gowning qualifications for manufacturing personnel.
- Responsible for environmental monitoring, excursion communication, reporting, investigation, disposition, and corrective action process.
- Supervised daily operations and testing requirements for the environmental monitoring program.
- Supported multi-department communication and approval for coordination of work performed (i.e. Operations, QC, Sanitization, Facilities, and QA).
- Provided complete and accurate documentation, have the ability to follow detailed work instructions reliably, and meet all aseptic gowning qualification requirements in order to perform these job responsibilities.
- Responsible for maintaining safety standards according to OSHA, laboratory cleanliness, and orderliness.
Supervisor, Quality Control
Artes Medical, Inc.
San Diego, CA
06.2008 - 03.2017
- Performed routine laboratory tests and routine inspections of raw materials and finished products.
- Conducted root cause analysis for non-conformances and reported findings.
- Prepared monthly reports on Quality Control activities for management review.
- Performed routine laboratory tests and routine inspections of raw materials and finished products.
- Performed lidocaine and hydroxyproline assays using the Empower HPLC System (Waters 2996).
- Assist in data review for final product release and stability protocols.
- Receive various samples and schedule them into weekly/monthly workload.
- Assist in developing and revising Standard Operating Procedures as needed.
- Improvement of analytical methods, such as pH, HPLC, and SDS-PAGE.
- Responsible for ordering lab supplies, small lab equipment, chemical inventory, and lab maintenance.
- Responsible for maintaining safety standards according to OSHA, laboratory cleanliness, and orderliness.
Chemist II, Quality Control
Artes Medical, Inc.
San Diego, CA
06.2007 - 05.2008
- Performed laboratory analysis of raw materials, in-process, and finished products to ensure compliance with quality lot release specifications.
- Maintained detailed records of all test results and prepared reports for senior management.
- Performed routine laboratory tests and routine inspections of raw materials and finished products.
- Assist in data review for final product release and stability protocols.
- Assisted in developing and revising Standard Operating Procedures as needed.
- Improvement on analytical methods such as pH, HPLC, and SDS-PAGE.
- Ordered supplies, inventoried chemicals and materials and summarized and recorded data to meet control and research requirements.
- Responsible for maintaining safety standards according to OSHA, laboratory cleanliness, and orderliness.
Sr. Laboratory Analyst
Quadrants Scientific, Inc.
San Diego, CA
10.2005 - 05.2007
- Company Overview: A GMP, GLP, ISO 9002, and FDA registered and inspected facility.
- Performed wet chemistry testing, total organic carbon, conductivity, and USP raw materials monograph testing.
- Supported analytical research scientist to develop and validate GC and HPLC assay methods.
- Affirmed microbial presence/absence in raw materials and final products via bioburden analysis.
- Monitored clean room environments for microorganisms and non-viable particulate contaminants.
- Quantified bacterial endotoxin levels of raw, in-process, and final products via gel clot, kinetic chromogenic, or turbidimetric methods utilizing WinK-QCL plate reader software.
- Reviewed analytical testing results to ensure data meets customer specification.
- Provided training and mentoring to other laboratory staff.
- Followed safety regulations and restrictions for accurate paperwork, filling system, and a clean, well-stocked laboratory.
Education
Bachelor of Science Degree - Biochemistry
The University of Akron
Akron, OH05-2004
References
References available upon request.
Timeline
Sr. Manager, Quality and EH&S
Suneva Medical, Inc., part of Tiger Aesthetics
01.2020 - Current
Manager, Quality Control
Suneva Medical, Inc.
04.2017 - 12.2019
Supervisor, Quality Control
Artes Medical, Inc.
06.2008 - 03.2017
Chemist II, Quality Control
Artes Medical, Inc.
06.2007 - 05.2008
Sr. Laboratory Analyst
Quadrants Scientific, Inc.
10.2005 - 05.2007
Bachelor of Science Degree - Biochemistry
The University of Akron
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