Nicole Monique Pearce

**** **** ****** *** # **, Mineral Ridge OH 44440

http://www.linkedin.com/in/nicole-pearce-149a6b96

336-***-****

Quality Associate Specialist

Highly organized, detail-oriented professional with diverse experience in GMP Shop Floor and Quality Processes. Demonstrates in-depth knowledge of GMP’s and FDA guidelines and regulations. Analytical minded strategist works well with cross-functional teams to analyze data. Collaborates with individuals at all levels of an organization to understand requirements and achieve organizational goals. Thrives in a fast-paced, dynamic environment with the ability to manage multiple tasks simultaneously.

SKILLS

Possess strong communication skills, including ability to interact in a team environment

Strong attention to detail and accuracy

Proficiency in Microsoft Windows and Microsoft Office, particularly Microsoft Excel

Excellent analytical and problem-solving skills

Extremely motivated, quick learner with excellent knowledge retention

Highly organized with the ability to prioritize tasks efficiently

Natural leader, mentor, and team player

Passionate self-starter driven to produce results

Monitoring

Complex Problem Solving

Time Management

Manufacturing Product

Laboratory Safety Operations

Attention to detail

Accountabilities

SQF

ISO 9001

May 2021-current

Quality Assurance Specialist, Paragon Foods

Warrendale, PA

Coordinate details for Purchasing Department to facilitate process of product rejections and projections.

Orchestrating platforms for HACCP Plans, Sanitation SOPs, and GMP programs.

Executed precise Food Safety System, monitoring all records for Critical Control Points within the division of Just Cut.

Diplomatic to customer relations for the release of products that are in specifications for data related product quality.

Accountable in collection of daily, weekly, monthly environmental testing elements at prescribed intervals and electively maintaining chain of custody information.

July 2019- April 2021

Quality Operations IPT VMF, (Merck Contractor) Fountain Group, Tampa, FL

Maintained detailed and comprehensive records for production cycle reports for Quality approval.

Advanced understanding of basic office applications, including Excel, SAP, PAS-X, EBR, Outlook.

Management over Particle Monitoring Systems with the instrumentation of LasAir units for logbook reviewal.

Inspecting AIMs and PI reports to find flaws and recommendations to automations for following guidelines per site procedures.

Attended meetings with coaches and Operations for manufacturing shop floor leaders and development teams. To communicate program changes; utilized information to update proper procedures and planning.

February 2019-July 2019

Quality Assurance VBF Sterile Supply, (Merck Contractor)

Fountain Group Tampa, FL

Audit results of processing production to verify conformance to Quality Assurance standards in Sterile Supply.

Apply knowledge of job performance requirements, equipment operation standards and product processing specifications.

Ensure WFI flushes to be within required time frame through MES interface.

Exported batch metrics for Bulk for process support equipment to ensure compliance autoclave parameters into SAP interface software with 100% accuracy.

Forecasted information for Autoclave logbooks, product processing sheets and specification sheets to verify that records adhere to Quality Assurance guidelines.

October 2018-January 2019

Quality Control Chemistry Lab Technician,

(Lanxess Contractor) Belcan, Raleigh, NC

Performed/monitored laboratory testing chemical polymers and plasticizers.

Utilized various instruments for viscosity, water saturation, color spectrometer, gas chromatography, density, refraction index, pH, chloride and basicity for products in instrumental testing.

Participated in group lab projects in Research and Development.

April 2017-July 2017

Quality Assurance Inspector, (Becton Dickenson Contractor) Lancesoft Inc. Herdon, VA

Reviewed completed production batches and laboratory records with accuracy before transaction.

Made acute observations to all deviations being investigated and resolved before releasing batches.

Pioneered and reviewed SOP, by suggesting better efficiency with all facets of production work by 5%.

March 2016-October 2016

Quality Assurance Environmental Technician, (Fuji Foods Contractor) Aerotek Greensboro, NC

As Lead Quality Assurance Technician oversaw compliance with Quality Control Environmental testing with food processes and procedures.

Head of HACCP and GMP of all facets of the company and negotiated revisions of production of product with USDA inspections.

Managed timely use of raw materials and minimizing discrepancies in the flow of production by half.

Facilitated the production of food products so that there is no contamination of food products during production.

Performed validation for all documents within laboratory and manufacturing areas in a structured manor.

March 2016-April 2016

Laboratory Technician, (Carolina Biological Contractor) Prime Personal Inc. Burlington, NC

Assisted the laboratory with assembling biology kits for universities and colleges nationwide.

Influenced assembly department of launching communication boards for time management and production department.

Improved communication between employees and management.

July 2014-March 2016

General Labor, Kyle Jarrett Construction Mebane, NC

In charge with purchasing supplies, lumber inspecting, keeping inventory of materials and oversaw all safety revisions.

Marketed with general contractors and pursued to build houses.

Supervised employees to ensure quality and safety are being met by implementing regulations on work site.

October 2011-March 2014

Formulations Toxicologist, Medtox Diagnostics, Burlington, NC

Formulated components for production of buffer solutions, stock gold and treated glass fiber with absolute accuracy of chemical measurements.

Pioneered diverse ways to utilize different material to be used during trial drug testing.

Contributed ideas within formulations department to facilitate updated instruments for more accurate results.

Organization of all files associated with Research and Development in code for new testing with swift efficient manner.

Committed to maximizing more product produced daily; exceeding numbers by 5 % presenting count methods for each batch.

March 2010-October 2011

Laboratory Technician,

(Medtox Diagnostics Contractor) Prime Personal Inc., Burlington, NC

Assembled components for testing, accession, assemble and dispense plasma for skin ampules.

Operation of (what are you saying here?) lyophilized product materials for diabetes on animal testing.

Preformed quality corrections to delegate visual testing including expiry dates and measurements.

EDUCATION

JUNE 2000

BRENTWOOD HIGH SCHOOL

Diploma

Recognition

September 2019: Identified fire safety event on shop floor in Lyo VMF 101. Observed electrical smoke from cables plugged into wall and alerted site services for help. Manager Jermaine McGill gave me the recognition.

July 2020: Data integrity remediation through managing equipment transition from paper based to electronic based. Overseeing Sixty Particle Monitoring Systems LasAir Units and tracked daily for cGMP/cGDP discrepancies. Head of Instrumentations Earl Manchester gave me the recognition.

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