Summary
Overview
Work History
Education
Skills
Timeline
Generic
Penny Mills

Penny Mills

Reidsville ,NC

Summary

Objectives Experienced quality professional looking to utilize their skills and experience in a challenging environment. Looking to provide continuous improvement in a Quality role to meet or better company goals.

Overview

13
13
years of professional experience

Work History

Quality Manager

Cintas
Graham, NC
05.2023 - Current
  • Worked effectively in fast-paced environments.
  • Managed time efficiently in order to complete all tasks within deadlines.
  • Demonstrated respect, friendliness and willingness to help wherever needed.
  • Passionate about learning and committed to continual improvement.
  • Self-motivated, with a strong sense of personal responsibility.
  • Strengthened communication skills through regular interactions with others.
  • Organized and detail-oriented with a strong work ethic.
  • Used critical thinking to break down problems, evaluate solutions and make decisions.
  • Adaptable and proficient in learning new concepts quickly and efficiently.
  • Worked flexible hours across night, weekend and holiday shifts.
  • Managed and archived quality documentation and participated in internal and external quality audits.
  • Coordinated and oversaw periodic audits to evaluate product quality and safety and address non-conformances.
  • Followed quality standards and procedures to minimize errors and maximize customer satisfaction.
  • Liaised with HR manager to organize and perform quality standard training for new and existing staff.

Quality Manager

Albaad US
09.2014 - 03.2023
  • Responsible for the quality of products and processes within the site
  • Management of QA department
  • Leads and manage all quality related programs, resources and activities on site
  • Responsible for compliance to relevant regulations on site
  • Drives improvement in the quality system
  • Member of the site management team
  • Ensure conformance with all applicable cGMP regulations
  • Authority to release or reject products upon review of all aspects relating to receiving, manufacturing, packaging and control of the final product
  • Responsible for timely managing and effective closure of Deviations and CAPA's
  • Customer Complaints
  • Approval of Product/System Change Controls
  • (APR) Annual product review
  • Production records review and approval
  • Documentation Management
  • Management review board (Scheduled and chaired quality review meetings to review effectiveness of performance mitigating risk, improving throughput and achieving customer satisfaction
  • Coordinated and oversaw periodic audits to evaluate product quality and safety and address non-conformances.
  • Approval of validation protocols & validation reports (IOQ, PPQ)
  • Involvement of Engineering specifications and drawings
  • Involvement and approval of preventive maintenance program
  • Responsible for the management of the pest control program.
  • Followed quality standards and procedures to minimize errors and maximize customer satisfaction.

Quality Coordinator

  • Assist Quality Manager in establishing, implementing and maintaining Quality Management System
  • Maintain Document Control program.
  • Work closely with manufacturing operations to identify and resolve production and quality deficiencies.
  • Responsible for continual improvement activities to enhance quality management system.
  • Participate in performing efficient implementation of quality standards, programs and processes to improve operational efficiencies and reduce/eliminate production waste.
  • Assist with development, review, and approval of processes and equipment validation/qualification activities.
  • Analyze deviations, develop, implement and follow up on CAPA's and assist in OOS and customer complaint investigations
  • Assist Purchasing in ensuring timely resolution of supplier nonconformities (NCR Program)
  • Active participant in performing Internal Audit Program
  • Assist in maintaining External Audit Program (FDA, ISO, FSC, and 3rd party) and assist with regulatory registrations (FDA, EPA)
  • Investigate and collect data in response to observations noted during internal and external audits to develop and complete CAPA plans.

Quality Assurance Lead

NCR
  • Ensuring QMS system is being adhered to
  • Working with Supervisors and Managers to ensure customer product meets specifications.
  • Inspection of Raw and Finished goods.
  • Document control
  • Implemented and controlled Plan and Unplanned deviations
  • Entering data into electronic system SAP
  • Collecting and entering in raw data concerning KPI for Management

Inventory Clerk

ConvaTec
02.2013 - 09.2014
  • Ordered material from warehouse daily depending on material and capacity requirements.
  • Perform physical moves of material from warehouse to work centers.
  • Ensure that work centers are supplied with correct material and amount needed for production.
  • Prep material for clean room when required.
  • Fill out reject forms when required.
  • Monitor SAP for location correcting negative system transactions.
  • Performed, verify and charge production order for each work center.
  • Oversees reconciliation material process daily.
  • Performs material cycle counts.
  • Train new employees.
  • Monitored and adjusted inventory levels to meet customer needs and demands
  • Kept documentation and records accurate and up-to-date with latest data to prevent errors in processing or delivery
  • Analyzed inventory trends to identify and prepare for potential issues and discrepancies
  • Completed stock inventories to identify and address issues negatively impacting controls.
  • Completed physical inventory counts each month

Test Coordinator

Ralph Lauren
02.2012 - 01.2013
  • Inspection of in process and final product to ensure customer specs are being met.
  • Usage of precise measuring equipment
  • Documenting and evaluating recorded data.
  • (Web P.D.M, Citrix, and QCI)
  • Ensure successful processing of test script along with processing instructions.
  • Monitoring of failed scenarios and work in process
  • Update test systems (HPQC with results of scenarios).
  • Liaise between ERP system and legacy system to communicate open scenarios and defects.
  • Enter Defects into test system and communicate defects to appropriate personnel.
  • Updated offline system and reported daily on all completed scenario, as well as providing additional scenarios to teams for testing.
  • Coordinated with systems partners to finalize designs and confirm requirements.

Education

Certificate - Cosmetology

Rockingham Community College
Wentworth, NC
05.2001

Skills

  • ISO 9001:2015, 22716
  • 21 CFR; 210, 211, 820
  • CGMP
  • Proficient in SAP, Word, Excel
  • Microsoft Teams
  • Document control
  • SOP
  • NCR and Deviations control
  • External and Internal Audits
  • Laboratory Technician
  • Set up SDA and TSA Plates
  • Proficient in the use of FTIR equipment
  • Proficient in using PH testing equipment
  • Micro stabbing production lines to test for bacteria
  • Communication
  • Team Player
  • Training employees
  • Proficient in SPC and KPI
  • Inventory management
  • Forklift operator
  • Inventory reconciliation
  • Inventory transaction for material going from warehouse to production
  • HR
  • Payroll
  • Onboarding new employees for Id's
  • Responsible for timekeeping and vacations requests for QA department

Timeline

Quality Manager

Cintas
05.2023 - Current

Quality Manager

Albaad US
09.2014 - 03.2023

Inventory Clerk

ConvaTec
02.2013 - 09.2014

Test Coordinator

Ralph Lauren
02.2012 - 01.2013

Certificate - Cosmetology

Rockingham Community College

Quality Coordinator

Quality Assurance Lead

NCR

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Penny Mills