Document Control Quality
Resume:
Tanquilla Lowe
Arlington, TN 38002
*************@*****.***
CAREER SUMMARY
Well-Organized and effective quality department leader with over 5 years of experience working within Quality Assurance, Quality Control, Contract Manufacturing Organizations and FDA regulated facilities. I have led several Quality departments while reducing costs, reducing safety incidents and increasing production of quality products. Focuses on deliverables while utilizing analytics and risk management strategies to maximize success. I Possess expert knowledge in cGMP,21CFRs, and EU requirements for regulated industries. Skilled with meeting expectations and applies process mapping and operational excellence tools to develop and revise processes/procedures. My career highlights include excelling at creating solutions, process improvements for manufacturing processes and working with multiple clients to help get safe and effective lifesaving drugs to patients. My career has been driven by roles that have provided me with an opportunity to provide quality assurance aimed at patient safety. I am an ethical leader who operates with a sense of urgency and thrives under pressure while focusing on being a team player with a cross-functional team.
SKILLS
Software: Outlook; Microsoft Word;
Microsoft Excel
Auditing
Training and Development
Adobe Acrobat; Access (database)
Nemawashi Process,
CAPA, Non-Conformance Investigations, Technical Writing
5S, LEAN Manufacturing, Six Sigma. Gemba Walks
Risk Management, RCA, cGMP, GDP. Failure Mode Analysis
FMEA Risk Assessment
Leading Remediation work streams for Federal Compliance
21CFRs, 483s, Value Stream Mapping
Process Flow Mapping, Operational Excellence
Project Management
Safety, Compliance and Regulatory
ISO 5, ISO 7 and Aseptic Technique
EXPERIENCE
Quality Assurance/Quality Control Investigations - Supervisor
PharMEDium, Amerisource Bergen – Memphis, TN
June2018-Current (BUSINESS CLOSING)
Responsible for review, approval and compliance approval for the facility from investigations written by QA/QC/Operation investigators.
Managed and delivered a turnaround time of 30 days or less for technical and compliance investigations.
Facilitated meetings with stakeholders to aid in remediation efforts and to address efforts needed to restart facility
Ensured cleanroom and aseptic technique was adhered while maintaining compliance to procedures and addresses non-compliance issues within the manufacturing department.
Participated in internal regulatory and customer audits.
Reviewed and approved deviations initiated by staff.
Served as site CAPA Coordinator regulatory/compliance
Coordinated CAPA meetings and trended analysis for CAPA/deviation metrics
Facilitated CAPA action flow through MasterControl and training in Compliance Wire while serving as MasterControl Sys Admin.
Approved Notification of Management to Executive Leadership and FDA
Reviewed recommendations and initiated the revision of standard operating procedures and provide rationale for changes.
Provide direction, scheduling and training of the QA investigators on new Master Control system, procedures, and day to day activities.
Reviewed and Approved OOS/OOL Lab Investigative reports.
Developed Quality Report (RTFT Metrics).
Reviewed and approved investigations and exception documents related to laboratories, batch processing, label and packing, environmental monitoring and training of specific procedures.
Approved the quality release of batches.
Supervised and developed 16 QA/QC Investigators.
Managed Customer Complaints, Compliance and Vendor investigations
Participated in cross-functional teams (CAPA Review Board) to identify effective corrective and preventive actions to improve process quality.
Developed Process Map for investigation flow throughout the facility using LEAN Manufacturing techniques.
Provide monthly/quarterly/ annually reports from QA and data to support other business functions as needed for continuous improvement efforts within the facility for operational excellence
Assisted in remediation’s and work streams during a consent decree to ensure regulatory and compliance concerns were met.
Solved and fixed compounding errors for production batches valued at $100,000/batch.
QA Risk Management -Manager
Cognate BioServices-Memphis, TN
January 2018- June 2018
Designing and implementing an overall quality risk management process for the organization.
Managed and provided constructive feedback to staff of 24-30 MFG and Quality Assurance employees.
Performed a risk assessment by analyzing current risks and identifying potential risks.
Performed a risk evaluation to determine if a CAPA is needed.
Evaluated the company’s previous handling of risks, and comparing potential risks with criteria set out by the company using HAZOP, FMEA and Fault Tree Analysis
Established the level of quality acceptable risk.
Developed a risk management cross functional teams using SME’s in different departments.
Created a training matrix that addressed the gaps in learning for the Manufacturing department.
Enforced SOPs, GMPs, GLPs, GDPs, and company policies.
Initiated and executed NCMRs, OSTs/OOSs, CAPAs, Media Fill Protocols, deviations and investigations.
Conducted policy and compliance audits to ensure compliance with FDA and EU rules and regulations.
Developed risk management controls and contingency plans.
Reviewed current aseptic technique process and conducted site wide re-training as a refresher for all employees.
Managed a team of 14 that assisted in facilitating and developing FMEA’s site wide.
Maintained records of completed risk management evaluations on a validated spreadsheet for review.
Established risk awareness by providing support and training within the company
Establish a reliable basis for decision making and planning.
Monitored implementation of action plans to ensure risk mitigation efforts are proceeding as required.
Created QA Technical Final Reports for leadership upon completion of risk analysis.
Assisted in developing Quality Agreements.
Collaborated with the Validations and Facilities Departments in the validation IQ, OQ, and PQ of manufacturing equipment.
QA Training /Document Control - Supervisor
Cognate BioServices –Memphis, TN
October 2017-January 2018
Maintained Controlled Documents in MC and ensure routing of documents.
Provided requested documentation for updating in a timely manner.
Ensured appropriate documentation were received/approved, formatted, updated and verified availability to users in a timely manner.
Assisted with QA electronic document control management e.g. SOPs, Forms, Material Specifications, Reports, Plans, BPRs etc.
Served as QA document control management of hard copy quality records, e.g. Master Binder for SOPs and Material Specifications, Client documents, etc.
Created and update documents, e.g. SOPs, Forms, Material Specifications, Label Specifications, Records.
Ensured current information is maintained and documents are controlled in the document control room. Documented listings (i.e., SOP, Client Documents, Employee Training, Forms, Specifications, etc.)
Provided updated listings to applicable folders for staff use as reference
Communicated and coordinate documents for Clients review in development.
Troubleshoot questions and issues with documents and electronic system
Coordinated document training configuration with department’s supervisor
Created and maintain document training electronically
Created and maintain electronic classes with Training Coordinator
Provided training to employees on GDP and GMP, quality-related topics.
Served as an internal auditor and records reviewer.
Monitored status of quality system and notified department management of overdue, incomplete and coming due items, e.g. SOPs, Reports, Plans, and Material Specifications.
Coordinated and maintained controlled documents in a secured location.
Issued & Reviewed log /logbooks documents
Train new associates in Master Control
Serve as backup for Change Controls new and existing request.
QA Medical Records Lead (Contract)
West Cancer Center - Germantown, TN
January 2017 –October 2017
Completed Referral Loops processes in OCM
Uploaded and reviewed all charts for new patients for Baptist doctors.
Completed New Patient Assessments Forms.
Lead and supervised a team of 6 OCM reps.
Completed and Released Referrals for medical offices and medical insurances providers
Completed and Responded to Email Portal Request from patients
Developed Physician Orders and answering calls from nurses and physicians
Gathered patient information by collecting demographic information from a variety of sources; interacting with registration areas and physicians' offices; retrieving information from MOSAIQ Software.
Delivered charts to assigned areas of the hospital by following established routing procedures.
Maintained data collection and skills acquisition files
Maintained records and completes required forms and documents in accordance with company policy and state and/or federal regulations.
Conducted audits for clinical trial patients
Quality reviewed documents prior to closure
QA/QC Document Control Export Specialist (Contract)
Meridian Health Life Science - Memphis, TN
March 2016 to November 2016
Distribution of Shipments to customers, customer invoice and payment collection for clients using Bartender
Responsible for administration and coordination of daily processes and establishing maintenance of Quality Systems and Master Control
Technical Writing for internal/external investigations
Managed communication with FDA and Internal Regulatory Bodies.
Act as a point of contact with external auditors and China customers with exports of products.
Responsible for answering questions regarding pricing and availability of products.
Coordinated continued compliance regulations. Ensure compliance with national and international standards and regulations.
Analyzed, evaluated and presented information concerning quality control, quality assurance and regulatory affairs related to current and future accounts with management team.
Implement systems to assess adequacy and effectiveness of QSM
Oversee the implementation of effective CAPA program to prevent reoccurrence of deviations.
Responsible for training files and addressing complaints from shipments within the warehouse.
Conducted and coordinated monthly QRB Meetings and release notes and new information to the company and employees.
Final reviewer for all QA documents prior to closure.
Provided necessary documents and excel spreadsheet using Microsoft Office, Visio, and Excel.
Conducted internal audits and client audits
EDUCATION
Capella University
Masters in Business Administration
*currently completing (December 2020)
University of Memphis
Bachelor of Arts in Criminal Justice-Pre-Law
Southwest Tennessee Community College
Associate of Science in Biology
CERTIFICATIONS
Sys Admin- Master Control
Technical Writing for Investigations/Non-Conformances
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