Sandra Valencia
Woodstock,IL
Summary
Dedicated and attentive individual with over fourteen years of experience in quality assurance and manufacturing operations. Proven ability to lead teams, analyze production metrics and implement effective quality control processes. Exceptional communication skills, with a strong commitment to maintaining ambitious standards in regulatory compliance and safety.
Overview
12
12
years of professional experience
Work History
Production Supervisor
WSS
Woodstock, IL
04.2023 - Current
- Oversaw daily production operations, ensuring adherence to safety and quality standards.
- Conducted root cause analysis on production issues for prompt resolution, minimizing negative impacts on output rates.
- Collaborated with management and engineering teams to develop and implement strategies for maximizing production efficiency without compromising quality standards.
- Mentored team members through regular feedback and performance evaluations, leading to professional growth and skill development.
- Collaborated with internal teams to streamline operations across materials handling, production, and shipping.
MQA Supervisor
WSS
Woodstock, IL
02.2022 - 04.2023
- Led shift quality assurance and environmental monitoring operations; scheduled QA specialists, EM technicians, and testing associates to optimize workflow.
- Established key performance indicators (KPIs) for monitoring quality metrics, ensuring alignment with organizational goals.
- Updated quality control standards, methods, and procedures to meet compliance requirements.
- Wrote and implemented new Standard Operating Procedures (SOP) to standardize processes and streamline workflow.
- Promoted a proactive approach to risk management within the organization, mitigating potential concerns before they escalated into larger issues.
- Collaborated across departments to track system holds, ensuring timely delivery of products to meet operational deadlines.
- Conducted regular audits and inspections to ensure adherence to quality protocols and regulatory requirements.
Quality Coordinator
Superior Felt & Filtration
McHenry, IL
08.2021 - 02.2022
- Coordinated training system for Medical Devices and Industrial production sites to ensure compliance and effectiveness.
- Performed incoming inspection on new materials and vendor samples and ensured all products met or exceeded customer requirements through testing and inspection procedures.
- Participated in the new production part approval process (PPAP)
- Created and managed Certificates of Compliance and Certificates of Analysis (COC/COAs).
- Assisted in preparations for ISO audits and customer visits
- Managed supplier surveys and compliance submissions.
- Maintained open communication channels between departments so that any issues could be quickly addressed before affecting overall product quality.
MQA Specialist
Catalent Pharma Solutions
Woodstock, IL
03.2019 - 08.2021
- Bubble Assignment as MQA Supervisor for six months from Mar 2021 – Aug 2021.
- Training and oversight of Production Testing Associates (PTAs).
- Prepared customer samples and reviewed Acceptable Quality Limit (AQL) sampling to facilitate timely batch releases.
- Monitored conformance of all batch documents, logbooks, and standard operating procedures to uphold compliance.
- Ensured compliance with industry standards by maintaining rigorous testing documentation.
- Served as a subject matter expert within the QA team, providing guidance and mentorship to junior team members and fostering a collaborative work environment.
Production Associate II
Catalent Pharma Solutions
Woodstock, IL
12.2014 - 02.2019
- Bubble Assignments as Deviation Technical Writer, Rapid Response Member, and Change Control Sponsor during this period of time as well
- Monitored manufacturing processes, identifying deviations and implementing corrective actions.
- Conducted routine inspections of machinery to maintain optimal functionality and reduce downtime.
- Took on additional shifts during peak work periods to keep projects on schedule.
- Established and maintained documentation standards to ensure consistency across all materials.
- Conducted reviews of technical content for accuracy, clarity, and completeness.
- Proved successful working within tight deadlines and a fast-paced environment.
Education
High School Diploma -
Woodstock High School
Woodstock, IL05-2010
Skills
- Production management
- Quality control
- Continuous improvement
- CAPA investigations
- Operational efficiency
- Team leadership
- Documentation management
- Schedule coordination
- Training and mentoring
- Content development
Timeline
Production Supervisor
WSS
04.2023 - Current
MQA Supervisor
WSS
02.2022 - 04.2023
Quality Coordinator
Superior Felt & Filtration
08.2021 - 02.2022
MQA Specialist
Catalent Pharma Solutions
03.2019 - 08.2021
Production Associate II
Catalent Pharma Solutions
12.2014 - 02.2019
High School Diploma -
Woodstock High School