Robin Doering
Corona,CA
Summary
Hardworking and dedicated Regulatory Affairs Specialist successful at preparing and documenting regulatory paperwork. Tireless in maintaining current understanding of legal regulations in order to keep all products compliant. Bringing eight years of manufacturing experience and seeking a growth-oriented position.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Sr. Regulatory Affairs Specialist
LGM Pharma Solutions, LLC
Irvine , CA
2022.11 - Current
- Evaluated proposed labeling changes for compliance with applicable regulations and guidelines.
- Organized and maintained all files related to regulatory actions.
- Managed upkeep of regulatory electronic and hard copy filing systems and archives.
- Oversaw and coordinated development of annual reports.
- Updated in-depth trackers of approvals and submissions.
- Evaluated changes to documents submitted to determine need for amendments.
- Submitted PADER, AR, SPL, CBE, IR and amendments to regulatory agencies.
- Collaborated closely with cross-functional teams on product design, manufacturing processes, quality assurance.
- Assisted in the preparation of technical documentation for registration submissions.
- Interpreted regulatory guidelines from multiple jurisdictions and provided advice accordingly.
- Ensured all required information is included in each submission package.
- Performed periodic reviews of existing products to ensure ongoing compliance with applicable laws and regulations.
Quality Assurance Supervisor
LGM Pharma Solutions, LLC
Irvine , CA
2021.11 - 2022.11
- Developed and implemented Quality Assurance policies, procedures, and standards.
- Conducted regular audits to ensure compliance with quality standards.
- Monitored production processes for efficiency and accuracy.
- Investigated customer complaints regarding product quality.
- Created reports on quality assurance results and presented them to management teams.
- Maintained accurate records of all inspection activities performed.
- Performed root cause analysis investigations into non-conforming products or processes.
- Verified that all customer orders met required specifications prior to shipment.
- Participated in internal and external audits as needed.
- Managed documentation control systems for tracking changes in design documents.
- Supervised onboarding and training of new personnel to maximize capacities of quality assurance team.
QA Lead
Cedars Sinai Biomanufacturing Center
West Hollywood , CA
2021.06 - 2021.11
- Reviewed requirements documents and technical specifications to provide timely and meaningful feedback.
- Analyzed existing systems for potential areas of improvement.
- Ensured that all projects adhere to company standards and industry regulations regarding quality assurance practices.
- Identified opportunities for improving the efficiency of the QA process through automation or other means.
- Reviewed standard operating procedures or quality assurance manuals to refine production processes or update for conformity to new regulations or policies.
- Spearheaded creation and implementation of work instructions and procedures, which led to a strong QMS.
- Conducted internal audits of the quality management system, identified non-conformances and developed corrective action plans.
- Performed root cause analysis to identify underlying causes of process issues and implemented preventative measures.
- Monitored supplier performance against established standards for material inputs used in production processes.
Quality Assurance Manager
CSL Plasma
Rialto , CA
2015.08 - 2021.06
- Developed and implemented quality assurance policies and procedures.
- Reviewed customer complaints and identified trends in order to develop corrective action plans.
- Conducted internal audits of processes, products, and systems to ensure compliance with quality standards.
- Monitored production activities for conformance to established quality requirements.
- Provided guidance on process improvements and best practices in order to maintain high levels of product quality.
- Trained personnel on the use of new technologies or techniques designed to improve product reliability or safety standards.
- Coordinated with other departments such as engineering, manufacturing, sales. in order to resolve any issues related to product quality.
- Established key performance indicators for evaluating the effectiveness of the company's quality management system.
- Performed root cause analysis on non-conforming materials or products in order to determine appropriate corrective actions.
- Created reports detailing results from inspections, tests, investigations., that were used by senior management for decision making purposes.
Education
Bachelor of Science - Biology
Central Washington University
Ellensburg, WA2015-06
Associate of Arts - Biology
Pierce College
Puyallup, WA2012-06
Skills
- FDA Submissions
- GxP Knowledge
- FDA regulations
- Inspections
- Regulatory Submissions
- Audits
- Time Management
- Continuous Improvement
Certification
- Six Sigma Green Belt, Cert: 22426 (ASQ)
- Improvement Associate Certification (CQIA), Cert: 14203 (ASQ)
Timeline
Sr. Regulatory Affairs Specialist
LGM Pharma Solutions, LLC
2022.11 - Current
Quality Assurance Supervisor
LGM Pharma Solutions, LLC
2021.11 - 2022.11
QA Lead
Cedars Sinai Biomanufacturing Center
2021.06 - 2021.11
Quality Assurance Manager
CSL Plasma
2015.08 - 2021.06
Bachelor of Science - Biology
Central Washington University
Associate of Arts - Biology
Pierce College
- Six Sigma Green Belt, Cert: 22426 (ASQ)
- Improvement Associate Certification (CQIA), Cert: 14203 (ASQ)
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