Regulatory Compliance Quality Management

Jacqueline Williams

Edison, NJ 732-***-**** **********@*****.***

PROFESSIONAL SUMMARY

Experienced Quality Specialist with over 8 years of expertise in regulatory compliance, quality management systems (QMS), and continuous process improvement within the healthcare and pharmaceutical sectors. Proven ability to manage FDA complaints, implement CAPA, and ensure compliance with cGMPs and federal regulations. Skilled at conducting audits, providing staff training, and collaborating cross-functionally to drive operational efficiency. Committed to maintaining the highest standards of product safety, data integrity, and regulatory compliance. Seeking a senior role to leverage my skills in quality management and regulatory affairs.

WORK EXPERIENCE

CSL Plasma, Edison, NJ

Quality Specialist – Sep 2023 - Present

Maintain and review Plasma center personnel training documentation, ensuring 100% compliance with CSL procedures, SOPs, CLIA/COLA, and other regulatory requirements.

Conduct thorough Quality Assurance (QA) record reviews, identifying and addressing deficiencies to maintain data accuracy and regulatory compliance.

Spearhead investigation initiatives for quality issues, ensuring prompt documentation of regulatory deficiencies and appropriate corrective actions.

Implement targeted retraining programs for staff, improving compliance scores by 15% and reducing error rates.

Promote safety, health, and environmental policies within the center, resulting in a 20% reduction in safety incidents.

Ensure compliance with local, state, and federal regulations, including ADA, Civil Rights, EEOC, FDA, HIPAA, and OSHA.

Manage a Quality Management System (QMS) to drive continuous improvement, resulting in a 10% increase in overall operational efficiency.

Key Skills & Competencies:

Root Cause Analysis Quality Management Systems (QMS) Regulatory Compliance Continuous Improvement Auditing Data Integrity Safety Compliance Corrective & Preventive Action (CAPA) Veeva Vault Trackwise

Sanofi, Bridgewater, NJ

Quality Specialist, Global Regulatory Affairs – May 2019 – Jun 2023

Led the management of FDA complaints for drug products and medical devices, improving the complaint resolution process and reducing response time by 25%.

Implemented and ensured compliance with cGMPs and federal regulations, focusing on biologics, combination products, and medical devices.

Developed and conducted training sessions on FDA regulations and 21CFR compliance for cross-functional teams, resulting in a 30% increase in team compliance knowledge.

Spearheaded CAPA processes, managing 30+ investigations annually, leading to a 15% reduction in quality issues.

Collaborated with regulatory agencies during FDA and international audits, maintaining a 100% audit pass rate during tenure.

Partnered with manufacturing sites to streamline export shipping processes, ensuring compliance with 49 CFR DOT and IATA regulations.

Key Skills & Competencies:

FDA Compliance Regulatory Affairs CAPA cGMP 21CFR Quality Audits Training & Development Risk Management Pharmaceutical Regulations

Quality Technician – May 2017 – May 2019

Oversaw the processing and documentation of product quality complaints, improving the timeliness of complaint resolution by 20%.

Collaborated with cross-functional teams, including customer service and medical information, to investigate technical complaints.

Managed monthly case reviews and generated detailed Quarterly Quality Assessment reports, increasing reporting accuracy by 10%.

Served as the primary liaison between customer service, sales, regulatory, and manufacturing teams to resolve complaints, ensuring efficient communication and quicker issue resolution.

Implemented a feedback system from departments to ensure continuous improvements in complaint handling procedures.

Key Skills & Competencies:

Data Entry & Processing Cross-Functional Collaboration Complaint Management Root Cause Analysis Reporting Quality Assessment

ANCNJ Non-Profit, Elizabeth, NJ

Bookstore Manager – June 2016 - June 2019

Managed store inventory and financial transactions, maintaining accuracy and reducing discrepancies by 20%.

Created and executed a marketing catalog, driving a 30% increase in customer traffic and exceeding sales targets for three consecutive quarters.

Partnered with vendors to ensure optimal stocking and fostered vendor relationships, increasing sales through special promotions and product bundles.

Developed and launched a customer survey that led to a 15% increase in relevant product offerings and higher customer satisfaction rates.

Increased store visibility and brand awareness through strategic promotional deals and outreach programs.

Key Skills & Competencies:

Inventory Management Marketing & Promotions Vendor Relations Sales Strategy Customer Service Financial Recordkeeping

Starbucks, Edison

Supervisor – May 2011 – May 2017

Led training and mentoring programs for new associates, improving employee performance by 25% within the first 90 days.

Managed daily store operations, including cash handling, supply orders, and inventory management, maintaining operational efficiency.

Implemented strategies to enhance customer experience, contributing to a 10% increase in customer loyalty scores.

Recognized for exceptional work performance with multiple awards, including "Best Work Performance" in January 2012, May 2014, and June 2015.

Key Skills & Competencies:

Team Leadership Staff Training Customer Service Cash Management Inventory Control Operational Efficiency

TECHNICAL SKILLS

Microsoft Office Suite (Excel, Word, PowerPoint) Adobe Cognos ACES-Siebel Global PTC Database Social Media Keyboarding (45 wpm)

EDUCATION

Kean University, Union, NJ

Bachelor of Arts in Public Administration

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