Quality Assurance Control

Felicia A. McAdams

*** ******* ****** *** *****, Connecticut 06511

Phone: 203-***-**** Email: **************@*****.*** 1

OBJECTIVE

Seeking to join an organization where I can utilize my leadership abilities and technical skills with experience in research, chemistry, quality, regulatory and manufacturing; as well as organizational, collaborative, and laboratory skills. Interested in long term opportunities to maximize my contributions to the organization’s various quality assurance, quality control, process development, and documentation protocols.

PROFESSIONAL EXPERIENCE

Assistant Regulatory Affairs Specialist June 2024 – Present KX Technologies West Haven, CT

• Effectively and efficiently collaborate with approved suppliers to successfully secure approved documentation.

• Successfully support engineering, R&D, and Sales with new product development by providing appropriate regulatory documentation.

• Attention to detail when requesting, reviewing, and organizing material declaration such as PFAS, REACH, Prop-65, TSCA, CEPA, RoHS, and GES for various water filter parts to meet customers’ expectations.

• Provide support to the project managers by providing them with approved material declarations for new projects.

• Successfully use Epicor ERP system to review product information. Quality Supervisor August 2023 – May 2024

Nissha Medical Technologies Wolcott, CT

• Successfully and correctly providing document control using ERP system Sage.

• Attention to detail when writing and reviewing SOP’s and work instructions.

• Provide documented training for new hires and any updated training for current employees.

• Carefully and completely review and release Document History Record through ERP system Sage.

• Effectively support engineering with change controls, pFMEAs, validation documentation and protocols using a quality management system and SharePoint

• Provide weekly Non-Conformance and CAPA reports to the Quality Manager, Engineering Manager, and Operations Manager.

• Site contact person for FDA, ISO, and other regulatory audits.

• Lead weekly Return Material Authorization meetings with details of the returns such as supplier, part number, quantity returned, and disposition of materials.

Quality Regulatory Specialist October 2022 – August 2023 Unipharm Waterbury, CT

• Writing and reviewing SOP’s and work instructions.

• Provide documented GMP training for new hires within the first week of onboarding.

• Effectively track all documented training for all employees.

• Supporting FDA and other regulatory audits onsite and virtually.

• Accurately review and release raw materials for production via QMS system.

• Creation, circulation, review/approval, and tracking of QC and Production documents, including, but not limited to operating procedures, Batch Records, test records, certificates of analysis, specifications.

• Supported manufacturing and other teams in the company, and compliance with, controlled documents. Felicia A. McAdams

325 Bassett Street New Haven, Connecticut 06511

Phone: 203-***-**** Email: **************@*****.*** 2

Global cGMP Compliance Specialist July 2022 – September 2022 SCA Pharma Windsor, CT

• GMP Lead internal auditor for both sites in Windsor, CT and Little Rock, AR.

• Perform quarterly GMP internal audits for all departments such as customer service, operations & production, procurement, and maintenance.

• Provide management with audit findings and collaborate with departments to make appropriate corrections needed.

• Reviewing an updating SOPs and Work Instructions according to compliance needs.

• Reviewing Batch Records, training records and other related documentation. ensuring that each department is compliant with all applicable FDA and 503 B regulations.

Quality Assurance Manager June 2021 – March 2022

CKS Packaging Naugatuck, CT

• Managing all the quality functions of the facility.

• Responsible for all training management duties to ensure compliance by all employees through training on multiple procedures/processes.

• Confirm all equipment within the facility is calibrated according to schedule.

• Program test methods into vision system for product testing.

• Accurately review test data and document pass/fails according to product specifications.

• KPI reporting of nonconformances weekly with management.

• Accurately creating C of C’s and C of A’s for passing product.

• Ensure the facility is always SQF compliant.

• Lead contact person for SQF and ISO audits.

• Thoroughly investigate consumer complaints using root cause analysis. Quality Assurance Manager June 2021 – March 2022

Thompson Chocolate Meriden, CT

• Managing the quality system of policies, procedures, and forms based on FDA and SQF food safety requirements.

• Training employees on HACCP, Preventive Controls, Sanitation, Food Safety, Documentation and GMPs.

• Facilitate internal audits, SQF audits, and FDA audits.

• Perform daily sanitization documentation review prior to production startups.

• Review and release raw material and packaging components COA’s and COC’s for production.

• Review and approve microbiological test results.

• Collaborate with internal teams through daily communication to ensure quality compliance. Quality Control Supervisor December 2013 – October 2019 Laticrete International Bethany, CT

• Supervising six quality control technicians.

• Verifying test results in QMS JD Edwards database for product release.

• Reviewing and writing work instructions for quality functions within the company.

• Verify calibrations of lab equipment according to schedule.

• Conducting internal audits to ensure all internal teams are compliant with quality standards.

• Provide Non-Conformance and CAPA report to the team via PowerPoint presentations.

• Working with R&D, Manufacturing, and Engineering to conduct plant trials for new products.

• Provide KPI’s and Right first-time reports to management.

• Collaborate with Procurement to order lab supplies.

• Support other plants by traveling to cover quality labs without a supervisor. Felicia A. McAdams

325 Bassett Street New Haven, Connecticut 06511

Phone: 203-***-**** Email: **************@*****.*** 3

Quality Assurance Chemist [Raw Materials] October 2002 – October 2012 Unilever Home and Personal Care Clinton, CT

• Evaluation of raw materials, bulk and finished products; utilize such instruments as Karl Fischer, auto titrators, moisture balances, densitometer, pH meter HPLC, FTIR UV-Vis, and viscometers.

• Communicate electronic and verbal releases according to batch processes.

• Collaborate with planning and production to assure materials are available in accordance with manufacturing schedule.

• Assist R&D with new product introductions and innovation.

• Communicate with R&D and Manufacturing on quality issues and collect/present date for troubleshooting.

• Communicate with vendors regarding quality issues and material availability.

• Perform microbiology lab work making media for microbiological testing.

• Participate in plant goal sharing and TPM efforts.

• Co-Chairman of Employee Safety Action Team.

• GMP Training Coordinator for new hire employees. Compounding Leader trainee

• Responsibilities included ingredient (raw, intermediates) pre-weighing bulk processing, data entry, and inventory control. Ingredients included oils, fragrances, colors/dyes, silicones, alcohols, fatty acids, and various specialty items.

• Interacted with production, warehousing, quality, planning and R&D to assure materials are available for daily manufacturing, trials, product scale ups.

• Sampled materials for testing and transportation to contract manufacturers, R&D, and other manufacturing locations. Research Associate March 2001 – March 2002

Bristol Meyers-Squibb Wallingford, CT

Organic/Inorganic Chemist October 1993 – August 2000 Accustandard, Inc New Haven, CT

• Prepared organic and inorganic chemical solutions used by the EPA, FDA, and others associated with environmental testing. Evaluated inorganic chemical solutions using instrumentation such as ICP, and GC-MS.

EDUCATION

Grambling State University, Grambling, LA

B.S. in Biology

A.S. in Chemistry

SOFTWARE/TECHNOLOGICAL/TRAININGS/OTHER SKILLS

• ISO 9000: Auditing, procedure implementation.

• Computer: SAP, Microsoft Word, Excel, Adobe PowerPoint, A/S 400, InterSpec, JD Edwards

• Total Productive Manufacturing (TPM).

• Hygienic Monitoring.

• HPLC Training with Waters for Basic Knowledge and Method Development Practices.

• Leadership & Supervision Training Middlesex College.

• High Performance Work Teams. GMP training coordinator for New Hire.

• 10 hours of OSHA training.

• Lean Manufacturing Training with CONNSTEP

• Certified SQF Practitioner, Certified PCQI, Certified HACCP training. Certified Internal Auditor.

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