Summary
Overview
Work History
Education
Skills
Timeline
Generic

DANIELLE N NICHOLSON

Rocky Mount,NC

Summary

Highly motivated individual, eager to utilize my expertise and professionalism to promote excellence in an established company.

Overview

17
17
years of professional experience

Work History

Senior Production Supervisor

Pfizer
Rocky Mount, NC
01.2023 - 02.2024
  • Established and updated production schedules to meet changing demands.
  • Reviewed individual employee performance to correct issues and enhance productivity.
  • Verified supply inventory and coordinated appropriate manpower to meet expected demand.
  • Scheduled staff work assignments, rotations and overtime.
  • Conducted interviews for qualified candidates
  • Monitored staff training and output to meet compliance productivity and revenue goals.
  • Coached and mentored employees to develop and enhance career skills.
  • Initiated work orders for repairs in order to plan maintenance of equipment, stationary and motorized machinery.
  • Provided input for performance reviews and identified areas for additional improvement.
  • Developed and implemented significant process improvements to enhance department quality and throughput.
  • Participated in cross-functional daily shift production meetings.
  • Facilitated task-specific meetings for upcoming shift/week.
  • Cultivated communication among senior managers and floor supervisors to encourage optimal productivity.
  • Documented batch records for manufacturing process and product history record-keeping.
  • Partnered with human resources on training compliance and performance progression methodologies.

Distribution Quality Engineer

Pfizer, Inc
Rocky Mount, NC
01.2022 - 01.2023
  • Collaborate with quality team members and leaders to monitor conformance to quality standards.
  • Develop interdisciplinary cross-training programs to expand competencies among team members and reduce knowledge gaps.
  • Perform root cause assessments of incidents and support investigation process to develop CAPA.
  • Annual Product Records Review (APRR) reports for Retains Department to determine possible need for modifying specifications or CAPAs
  • Support Warehouse and Logistics Team in implementing corrective actions to temperature excursions on product in transit and all storage locations.
  • Maintains Mean Kinetic Temperature data for all site warehouses and storage locations.
  • Attend to temperature excursions that may arise within refrigerated or non-refrigerated storage locations
  • Perform Global Batch Holds or Releases in SAP per market request

Manufacturing Quality Engineer

Pfizer Inc
Rocky Mount, NC
09.2017 - 01.2022
  • Maintain quality oversight for the R2 Facility
  • Collaborate with departmental subject matter experts to assess production inconsistencies in accordance to quality expectations
  • Perform weekly process verification guide (PVG) audits throughout the facility
  • Restrict any product or equipment that may be compromised in the event of an environmental discrepancy, in the Restriction Tracking System
  • Perform nightly room and area inspections
  • Initiates Environmental Discrepancy Reports or Open Area Requests
  • Assist with the initiation of PRs or CAPAs

Production Technician- Solution Operator

Pfizer Inc
Rocky Mount, NC
03.2015 - 09.2017
  • Ensured that any tanks, hosing, or any other equipment that will be used has been rinsed with HWFI for the time specified in the corresponding batch record and are pH tested and also for oxidizable substances and conductivity.
  • Checked the pH of solution during and after mixing processes to ensure that it is at its proper pH level according to validation standards for that particular drug.
  • Made sure that all scales were calibrated before drug weighing.
  • Checked lot numbers and retest or expiration dates before drug weighing.
  • Ensured that only API (active pharmaceutical ingredients) or controlled drugs listed on the Bill of Material and Drug Requisition Form are dispensed into the correct tanks.
  • Stayed current with SOPs and web-based PLS trainings or instructor-led trainings

Production Operator

Hospira Inc
Rocky Mount, NC
10.2013 - 03.2015
  • Followed correct gowning procedures before entering production area.
  • Followed correct GMP and PPE instructions per SOP and area requirements
  • Performed line clearance at the end and beginning of production run or changeovers.
  • Verified commodity codes and lot numbers against Bill of Materials
  • Signed correct commodities into the line on specified form.
  • Verified lot number of product.
  • Verified lot numbers of appropriate sanitizing agents used.
  • Performed hourly water pressure checks on washers.
  • Performed visual inspection of vials and place onto infeed table of washer.
  • Placed the trays of glass ampuls on the washer to be washed.
  • Placed trays of glass ampuls on the heat tunnel belt for drying process.
  • Removed trays of glass from the opposite end of the heat tunnel (located in the filling room).
  • Verified correct fill volumes of solution after technician performs check.
  • Performed hourly checks to ensure correct amount of vials are being distributed.
  • Ensure each completed pallet is ticketed with correct information (content, lot number, quantity, date, signature of at least one line attendant, etc.) before it is picked up by autoclave attendant.

Quality Assurance Technician

The Cheesecake Factory Bakery
Battleboro, NC
06.2007 - 09.2012
  • Responsible for Product Quality Guarantee (PQG) and GMP compliance on the production floor.
  • Conduct and documents a variety of visual and functional testing in support of commodity and product release.
  • Calibrate metal detectors and weight checker on production line as described in the HACCP program.
  • Conducts ATP and allergen test swab tests and collected samples as required for finished product or ingredients.
  • Verify and inspect the cleaning of equipment along with conducting sanitizer concentration checks.
  • Conduct tests such as batter density, viscosity, temperature readings, crumb density.
  • Issue batch documents to production team.
  • Verify proper weighing of ingredients per specification.
  • Verify traceability of ingredients and packaging material.
  • Verify packaging and labeling requirements for finished product.
  • Assist with testing for new products development.
  • Responsible for overseeing quality assessment systems of the organization.
  • Collect samples from the manufacturing unit for quality tests.
  • Calibrate metal detectors and checkweigher machines.
  • Assist QA Supervisors and Managers in performing quality control analysis on production systems and manufacturing goods.
  • Assist management teams in making modifications to the systems per audit report suggestions.
  • Coordinates with production team to prevent inconsistencies and wastages.

Education

Bachelor of Arts - Psychology, Minor in Criminal Justice

North Carolina Wesleyan College
Rocky Mount, NC
2015

Skills

  • Report Writing
  • Aseptic Certified
  • Certified Fellow Employee
  • gQTS and eQMS (investigations)
  • AS400
  • Method 1 Analysis
  • SAP (Global System)
  • gLIMS for Change Management
  • Kronos

Timeline

Senior Production Supervisor

Pfizer
01.2023 - 02.2024

Distribution Quality Engineer

Pfizer, Inc
01.2022 - 01.2023

Manufacturing Quality Engineer

Pfizer Inc
09.2017 - 01.2022

Production Technician- Solution Operator

Pfizer Inc
03.2015 - 09.2017

Production Operator

Hospira Inc
10.2013 - 03.2015

Quality Assurance Technician

The Cheesecake Factory Bakery
06.2007 - 09.2012

Bachelor of Arts - Psychology, Minor in Criminal Justice

North Carolina Wesleyan College

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DANIELLE N NICHOLSON