Soozie K. Caldera
Brush Prairie,WA
Summary
Quality-focused manufacturing leader with extensive experience in consumer-packaged goods and contract manufacturing. Expertise in managing investigations, driving corrective actions, and developing SOPs to ensure cGMP compliance. Proven ability to enhance documentation control and collaborate across functions to deliver safe, compliant products.
Overview
31
31
years of professional experience
1
1
Certification
Work History
Quality Assurance Senior Supervisor
Piping Rock Inc. (formerly Church & Dwight)
Vancouver, USA
11.2007 - Current
- Led daily operations of QA and QC floor staff, aligning activities with company policies and regulatory requirements to maintain quality standards.
- Manage investigations and root-cause analysis for quality incidents; drive corrective and preventive actions (CAPA) to closure.
- Develop, review, and revise Standard Operating Procedures (SOPs) and work instructions to maintain cGMP compliance and operational consistency.
- Coordinated internal and external audits, preparing documentation and implementing findings to enhance compliance and operational integrity.
- Maintain organized, secure quality documentation and records to support traceability and regulatory inspections.
- Provided cross-functional guidance to production, R&D, and supply chain teams, ensuring product quality and adherence to compliance standards.
Office Manager
Create A Scape Inc.
Temecula, USA
03.2004 - 08.2007
- Managed office operations, overseeing payroll processing, coordinating vendors and suppliers, and procuring office supplies to ensure smooth daily functions.
- Executed month- and year-end financial closing activities while maintaining appointment schedules and administrative workflows to ensure organizational efficiency.
- Reviewed contracts and secured required permits from local government offices, facilitating timely project execution.
Quality Coordinator
Thoro Packaging
Corona, USA
09.1995 - 03.2004
- Enforced company safety, quality, and GMP policies on the production floor; translated customer requirements into actionable manufacturing specifications.
- Defined inspection and testing criteria to verify product conformance and supported quality acceptance decisions.
- Managed customer complaint tracking and response processes, ensuring effective corrective actions and identifying trends for continuous improvement.
- Collaborated with suppliers to communicate customer and plant requirements, ensuring compliance of incoming materials with quality standards.
- Authored and updated procedures, work instructions, and forms within the QMS to enhance operational consistency and support quality management.
Education
High School Diploma -
Atwater High School
Atwater, CA06-1993
AAS - Supervisory/Management Development
Portland Community College
Portland, OR04-2026
Skills
- Quality management systems
- CGMP knowledge
- CAPA management
- SOP development
- Document control
- Audit support
- Investigative analysis
- Root cause analysis
- Supplier quality
- Complaint resolution
- Training development
- Team leadership
- Record keeping practices
Certification
- Food Defense course certification
- 21 CFR Part 111 training
- Natural Product Licensing Certificate (Health Canada)
Timeline
Quality Assurance Senior Supervisor
Piping Rock Inc. (formerly Church & Dwight)
11.2007 - Current
Office Manager
Create A Scape Inc.
03.2004 - 08.2007
Quality Coordinator
Thoro Packaging
09.1995 - 03.2004
High School Diploma -
Atwater High School
AAS - Supervisory/Management Development
Portland Community College