Crystal P. Email & Phone Number

Washington, Dc, Us

Houston, Texas

Raleigh, North Carolina

Responsible for being a liaison to Biomat S.A regarding compliance with European Regulatory authorities by providing on-site support during inspections by European authorities.

Houma, Louisiana

Developed and executed the yearly plan for Quality in the Houma center which concentrated on creating a “Culture of Excellence”, while focusing on being a service to donors and employees. Maintain quality assurance procedures and activities required to ensure that Standard Operating Procedures (SOPs) are properly interpreted and that employees performs according to all SOPs.Established continuous training for all employees to ensure the center is compliant at all times. Established weekly monitoring and forecasting of Quality KPI to be more proactive in mitigating the center risk. Conducted workshops, educating employees on their impact on Quality processes within the center. This initiative led to the reduction of critical errors. Oversee and perform the execution of all aspect of internal and external quality system audits. Responsible for driving initiatives to ensure quality activities are compliant, effective, feasible and continue to produce desired results.Sets standards of performance for quality associates and measured performance on monthly, quarterly and yearly basis while taking applicable corrective actions if necessary.

Houston, Texas

Houston, Texas Area

Increase accuracy in achieving goals by developing, establishing, integrating and improving all work instructions and process maps to align with QC standards and technical processes.-Improve results by investigating root cause analysis and proactively creating corrective action plans for all quality observations and customer complaints discovered while leading customer and external audits.-Leverage an expertise in Six Sigma methodologies to monitor and measure trends, resulting in an improved customer experience, optimized operational efficiency and lowered cost. -Mitigate deviations from targets with bi-quarterly realignment based on assessment of activities, analysis of data and highlighted inefficiencies to integrate timely corrective action plans and permanent solutions. -Enhance employee integration by training and mentoring 100 employees to develop the necessary success skills to achieve initiatives while spearheading the re-education program across multiple departments.-Advance QA by encouraging cross-functional teams to increase transparency and communication while supporting efficient implementation of operating procedures and processes. -Champion company wide engagement in QC initiatives by producing weekly Friday symposiums focusing on creating a quality conscious staff within production.

Houston, Texas Area

-Safeguarded the end user experience by delivering customer required documentation (Certificate of Analysis and Compliance) confirming quality, accuracy and regulatory compliance.-Advanced the continuation of workflow by proactively maintaining and calibrating test equipment.-Minimized risk by deploying investigational techniques to satisfy regulatory requirements and deliver accuracy while performing complex testing on production batches to measure chemical and physical characteristics.-Reduced costs by building relationships in the supply chain and strategically allocating inventory in the network.-Served as a technical “go to” for successfully completing product re-certification testing.

Houston, Texas Area

Boosted efficiency by developing quality and reliability standards with verifiable specifications to identify raw material conditions including collecting samples, conducting inspections and analyzing samples -Aligned products with QA initiatives by collecting, classifying, analyzing and interpreting production and quality data to judge product acceptability in comparison with specifications.-Leveraged a technical expertise to document finished product status including recording and summarizing raw material, in-process and finished product inspection and test data into the database.-Achieved QA in operations by managing the trend analysis to align results within controlled metrics for GMP’S, OSHA, HACCP, GLP’s and rules and regulations.