Jon Dale
Daly City,CA
Summary
Results-driven Analyst, skilled in analytical problem solving and collaboration. Proven track record in ensuring compliance with quality standards and regulatory requirements, while effectively managing raw material inspections. Detail-oriented and organized, I excel in timely material disposition and CAPA implementation, enhancing operational efficiency in a fast-paced environment.
Overview
21
21
years of professional experience
Work History
Analyst II, QC Raw Materials and Control
Astellas Gene Therapies
South San Francisco, USA
12.2021 - 10.2024
- Support manufacturing, ensuring that raw materials used, or other regulated products, meet quality standards and regulatory requirements.
- Perform qualitative and quantitative analyses of raw materials, including excipients, active pharmaceutical ingredients (APIs), and packaging components.
- Review and verify Certificates of Analysis (CoAs), and vendor documentation.
- Oversee and perform GMP-compliant sampling of raw materials in controlled environments.
- Conduct visual inspections for damage, labeling, and container integrity.
- Record, review, and verify laboratory data in Oracle and laboratory notebooks, following ALCOA+ principles.
- Evaluate test results and documentation to support the release or rejection of raw materials.
- Work with QA, Manufacturing, and Supply Chain teams to ensure timely material disposition.
- Identify and report OOS, OOT, and deviations.
- Participate in investigations, and assist in root cause analysis and CAPA implementation.
- Follow and help revise Standard Operating Procedures (SOPs), test methods, and work instructions.
- Assist with internal and external audits, and inspections.
- Interface with Quality Assurance (QA), Procurement, Warehouse, and Regulatory Affairs for raw material status and compliance issues.
- Work with contract testing laboratories (CTLs) for QC sample testing activities: obtaining quotes and POs, scheduling testing, and shipment to meet timelines.
Analyst, QC Raw Material Inspection and Release - Temporary
Audentes Therapeutics
South San Francisco, USA
11.2020 - 12.2021
- Collect and label samples of incoming raw materials in accordance with SOPs and safety guidelines.
- Ensure that sampling is done in controlled or classified environments, if required.
- Perform a visual inspection of materials for damage, contamination, and labeling compliance.
- Verify materials against the certificate of analysis (CoA), and delivery documentation.
- Conduct routine analytical testing (e.g., pH, conductivity, identity tests, osmolality, titrations, etc.). On raw materials per compendial (USP, EP) or internal methods.
- Document results accurately in lab notebooks or electronic systems.
- Ensure complete and accurate documentation of all analyses and inspections.
- Follow ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate).
- Support the disposition process by ensuring timely testing and documentation for release or rejection.
- Follow Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP).
- Support deviation investigations and corrective/preventive actions (CAPAs) when applicable.
- Collaborate with QA, warehouse, procurement, and manufacturing teams regarding raw material status, issues, or delays.
Upgrade Supervisor/Warehouse Manager
Gerson Bakar & Associates
Daly City, CA
01.2010 - 01.2020
- Supervised daily operations and ensured adherence to company policies.
- Coordinated staff schedules to optimize workflow and resource allocation.
- Oversee and manage interior and exterior unit upgrades, remodels, and capital improvement projects across multiple properties.
- Managed inventory levels and organized supply chain processes.
- Work closely with property management, leasing agents, and maintenance supervisors.
- Maintain accurate records of upgrades, change orders, and completed work.
- Oversee daily warehouse operations, including receiving, storing, picking, packing, and shipping of goods.
- Maintained strong vendor connections at all stages, including arranging pricing, delivery structures, and managing specific shipment or paperwork concerns.
- Improved delivery plans with strong scheduling knowledge, organizational skills, and route development expertise.
- Created plans to propose solutions to problems related to efficiency, costs or profits.
Operations/Customer Service
Gerson Bakar & Associates
Daly City, CA
01.2004 - 01.2010
- Support residents by responding promptly to their inquiries, addressing maintenance requests, and following up to ensure resolution.
- Schedule and oversee routine maintenance, unit turns, and emergency repairs.
- Manage relationships with vendors and contractors for specialized services (e.g., HVAC, plumbing, pest control).
- Ensure work orders are completed in a timely, cost-effective manner.
- Promote a positive and productive work environment.
- Ensure compliance with fair housing laws, ADA requirements, local ordinances, and safety codes.
- Collaborated closely with team members to achieve project objectives and meet deadlines.
Education
Associate of Applied Arts - Aeronautics
City College of San Francisco
San Francisco, CA01.2003
High School Diploma - Daly City, CA
Westmoor High School
Daly City, CA01.1997
Skills
- Collaboration and teamwork
- Analytical problem solving
- Detail-oriented approach
- Effective time management
- Composed demeanor
- Organizational skills
Awards And Acknowledgements
- Employee of the year, 2011
- Won multiple Employee of the Month, Various
Timeline
Analyst II, QC Raw Materials and Control
Astellas Gene Therapies
12.2021 - 10.2024
Analyst, QC Raw Material Inspection and Release - Temporary
Audentes Therapeutics
11.2020 - 12.2021
Upgrade Supervisor/Warehouse Manager
Gerson Bakar & Associates
01.2010 - 01.2020
Operations/Customer Service
Gerson Bakar & Associates
01.2004 - 01.2010
Associate of Applied Arts - Aeronautics
City College of San Francisco
High School Diploma - Daly City, CA
Westmoor High School
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