Amy Williams

About Amy Williams

Deadline-oriented Quality Assurance Specialist with 20+ years of experience in the regulated industry, executing cross-functional communications across multiple business units, suppliers, and customers to share best practices that optimize efficiencies, maximize productivity, and strengthen performance for enhanced profitability. Resourceful team player with expertise in quality assurance, root cause analysis, non-destructive testing, standard work development, statistical process controls, and MS Office Suite. Results-oriented and organized strategic planner seeking to leverage background into a quality assurance specialist or data management associate role with a progressive organization. Key contributions include:• Utilized review and queries to apply self-evident case corrections per the Data Validation Specification (DVS) and data management plan, and resolve respective queries or re-queries.• Supported Rave studies by performing data management quality reviews and internal QC checks per Electronic Data Capture (EDC) systems.• Conducted in-process solid dose pharmaceutical product inspections/physical tests, examining common pharmaceutical dosage/physical analysis of product (ensure quality, strength, safety, identity, purity, efficacy).• Mitigated regulatory risks by conducting continuous review of SOPs, specifications, and GMPs to ensure compliance to FDA and OSHA compliance protocol.• Maintained QA operations by following Federal Code of Regulations.• Strengthened traceability by accurately collecting, classifying, analyzing, and interpreting production and quality data to document results of in-process inspections for FDA review and product release.SKILLS:Quality Assurance | Inspections | Audits | Regulatory Compliance | Team Leadership | Operations Management | Safety Compliance | Documentation & Support Services | Planning & Controls | Interpersonal Communications | Time Management | MS Office Suite | Oracle Clinical RDC 4.5.3 | Livelink | Trackwise | Phase Forward InForm4.6 | Medidata Rave 5.6 | MS Dynamics AX | Safety Committee Member | Subject & Medical Review Trackers | Metrics Reporting | Queries | Data Cleaning | Data ListingsTHERAPEUTIC EXPERIENCE:Hematology: Sepsis | Hepatic Disorders/Liver: Viral Infection | Nephrology: End-Stage Renal Disease Anemia/Hemodialysis & Peritoneal Dialysis/Renal Anemia | Skeletal Diseases: Musculoskeletal Diseases | Acute Myeloid Leukemia: Targeted Therapy/Chemotherapy

Experience

1. Data Manager

   PharPoint Research, Inc.

   Nov 2020 — Present · Wilmington, NC, US

Skills

• Regulatory Submissions
• Leadership
• Clinical Trials
• Regulatory Affairs
• Ich-Gcp
• V&V
• 21 Cfr Part 11
• Clinical Research
• Capa
• U.s. Food and Drug Administration (Fda)
• Gmp
• CRO
• Pharmaceutical Industry
• Sop
• Fda
• Biotechnology
• Data Management
• Validation
• Gcp
• U.s. Title 21 Cfr Part 11 Regulation
• Clinical Development
• Quality Assurance
• Standard Operating Procedure (Sop)
• Software Documentation
• Edc
• Ctms
• Computer System Validation