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Quality Control Assurance

Location:
Knightdale, NC
Posted:
January 29, 2024

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Resume:

Susan Squires

ad2648@r.postjobfree.com

www.linkedin.com/in/susan-squires-33a6a239

919-***-****

Education and Certifications

● Masters (13 hours) - 2000

● Bachelors of Science - 1997

● Associates of Science - 1997

● Lab Animal Technologist (LATG) - 2012

● Pathways Leadership Development Program - 2003

● BioWork Certified Bio-Process Technician (NC CPT # 011223) - 2019

● Aseptic Processing I BTEC - 2020

● HPLC Theory and Practice BTEC - 2020

Skills

● Collaboration

● Continuous Process Improvement

● Non-conforming Events (NCE)

● Impact assessments / Method development

● Troubleshooting identify, evaluate, and recommend solutions / Root Cause Analysis

● Study deviations

● Quality guidelines QA/QC

● GLP study regulations (21 CFR Part 58)

● Audit findings / Data Integrity and Regulatory Compliance

● SOP / Protocol

● Preclinical in-vivo studies

● Attention to detail

● Equipment maintenance /calibration repair procedures

● Data review and management Laboratory Information Management Systems (LIMS)

● Molecular and Microbiology Biology (High Complexity Testing - PCR, Cell Culture) (Equipment - Balance, Pipette, Autoclave, Hamilton Microlab Star Let, Kingfisher Flex, Inverted light microscope (DFA testing), Heracell 150i CO2 incubator)

● Word, Excel and PowerPoint

● Teaching Technical Skills and Procedures

● Current Good Documentation Practices (cGDP)

● Basic HPLC operation and solution preparation

Full-time 40 hours/week

Team Member

Medical Laboratory Technician I

March 2022 - January 2023

North Carolina DHHS

4312 District Drive Raleigh, NC 27607

919-***-****

● CLIA ’88 requirements

● High complexity laboratory testing

● Attention to Detail

● MS Word, PowerPoint, Excell

● (QA) quality control

● (QC) quality assurance

● Cell culture

● Viral culture

● Proficiency sample testing

● Mycobacterium testing

● Environmental testing and monitoring: Ph, temperature, humidity

● Molecular testing

● Necropsy

● DFA diagnostic testing

● Clinical specimen processing

● Preform, record, and evaluate daily, weekly, and monthly maintenance and calibration on equipment in the laboratory

● Experienced in troubleshooting equipment issues, reporting results, and providing consultation to healthcare providers and other related professionals on the interpretation of test results

● Participate in the evaluation, performance verification/validation, and implementation of new methods and techniques

● Perform tests accurately and in the established turn-around time

● Record and evaluate daily quality control documents for each assigned assay

● Knowledge of the principles, procedures and hazards with (PIM) potentially infectious materials

● Followed EPA protocols

● Weighing / measuring and disposing of hazardous waste properly

● Understand and accurately follow complex oral and written instructions

● Read and comprehend technical materials

● Equipment used (Hamilton Microlab Star Let, KingFisher Flex, (Inverted light, Fluorescent) microscope, Heracell 150i CO2 incubator, -80 freezer)

● Programs: LIMS, 7500 Fast Real-Time PCR System

● Assays performed (Quidel - Lyra Direct)

● Ensured data integrity and compliance

● Establish and maintain effective working relationship

● Maintained proper sample chain of custody

● Audited patient forms for errors

● Entered patient PHI data in LIMS database

● Maintained laboratory efficiency with proper inventory and storage

● Performed (Covid-19 Assay extraction)

Full-time 40 hours/week

Team Member

Medical Laboratory Technician

July 2020 - February 2022

Temporary Solutions - NC DHHS

4312 District Drive Raleigh, NC 27607

919-***-****

● CLIA ’88 requirements

● High complexity laboratory testing

● Entered patient PHI data in LIMS database

● Attention to detail

● (QA) Quality control

● (QC) Quality assurance

● Preform clinical specimen processing

● Preform, record, and evaluate daily, weekly, and monthly maintenance and calibration on equipment in the laboratory

● Experienced in troubleshooting equipment issues, reporting results, and providing consultation to healthcare providers and other related professionals on the interpretation of test results

● Participate in the evaluation, performance verification/validation, and implementation of new methods and techniques

● Perform tests accurately and in the established turn-around time

● Record and evaluate daily documentation

● Infectious disease testing

● Followed EPA protocols

● Weighing and measuring

● Hazardous waste disposal

● Understand and accurately follow complex oral and written instructions

● Read and comprehend technical materials

● Equipment: Hamilton Microlab Star Let, KingFisher Flex, microscope, -80 freezer

● Data integrity and compliance

● Establish and maintain effective working relationship

● Pipeted primary samples

● Maintained clinical sample chain of custody

● Audited patient forms

● Data Entry of Protected Health Information (PHI)

● Maintained laboratory efficiency with proper inventory and storage

● Reporting results

● Provided consultation to healthcare providers

● Recorded and evaluate daily quality control for each assigned assay

● Knowledge of the principles, procedures and hazards with (PIM) potentially infectious materials

● Covid-19 Assay extraction

● MS Word, PowerPoint, Excell

Full-time 40 hours/week

Team Member

Sales Associate

June 2020 - July 2020

Home Depot

1020 Shoppes at Midway Dr Knightdale, NC 27545

919-***-****

● Customer service

● Loss prevention

● Sales transactions

● Stocking merchandise

Full-time 40 hours/week

Contractor

Certified Nurse Assistant

August 2012 - June 2018

Visiting Angels

5700 Six Forks Rd. Raleigh, NC 27609

919-***-****

● Quality Assurance (QA) via documentation and updates for team on patient status

● Identified opportunities for process improvement within the company

● Served as liaison between families and doctors

● Facilitated activities of daily living ADL’s

● Aseptic gowning and PPE

● Facilitated long term post-operative recovery

● Provided behavioral and emotional support and supervision Full-time 40 hours/week

Senior Team Member

Laboratory Technologist

December 2004 - August 2012

GlaxoSmithKline

5 Moore Dr Durham, NC 27709

919-***-****

● Performed pharmaceutical research and development in a cGMP, GDP and GLP environment with bio-hazardous and radioactive materials

● Research Technician of the Year 2009

● Multiple R&D Recognition Awards 2005-2011

● Lectured and held a panel discussion at a AALAS national conference

● Contributed as primary lab tech to pub-med articles

● Assessed training needs and developed education materials and facilitated training in classroom setting for new laboratory employees

● Applied critical thinking skills to meet goals, deadlines and budget challenges

● Used out of the box thinking to design animal studies and engineer devices

● Developed and maintained partnerships with more than 20 scientists and vendors

● Worked in a BSL 2 aseptic environment

● (QA) quality control

● (QC) quality assurance

● Statistical analysis

● Attention to Detail

● Preformed aseptic technique and gamma irradiation

● Stayed abreast of emerging pharmaceutical applications and diagnostic tools

● Maintained and calibrated microscopes and moderately complexity lab equipment

● Managed priorities to take care of 200+ study candidates

● Environmental microbial monitoring via noise levels, swab and plate count

● Cleaning and disinfection of aseptic areas

● Aseptic gowning

● Necropsy State and Federal Environmental Regulations Research Technician

● Preformed in-vivo dosing - SQ, ID, IM, IP, IV, gavage, port and radioactive via MRI

● Resolved primary enclosures/space requirement problems

● Data integrity, compliance and forward/backward traceability

● Contamination control parameters

● Completed routine lab tests

● Generated reports with Word, Excel and PowerPoint

● Equipment maintenance/ calibration

● Aseptic processing and PPE

● Warehousing, distribution and budgeting

● Performed pharmacokinetic and pharmacodynamic studies

● Formulated standard operating procedures (SOP’s)

● Identified opportunities for staff recognition

● Conducted non-departmental staff new employee orientation

● Instigated operational changes to align two merging facilities

● Expedited internal audits and customer surveys

● Interpreted and presented mathematical / data-driven recommendations to senior leadership

● Facilitated 10% increase in cleaning productivity

● Facilitated and designed research studies

● Helped to implement “Bring your kids to work day”

● Prepared and dosed radioactive treatments with MRI

● Monitored pre-op and post-op surgery candidates

● Represented department on committees, panels and groups

● Chemical reactions and safety when compounding drug products

● Water and air filtration and quality assurance and control

● Performed 24/7 data point collection samples and dosing

● Worked with management to maintain obese subjects Collected and evaluated environmental data Animal Care Assistant

● Prioritized tasks to handle unexpected situations

● Collaborated with teammates to solve problems

● Performed Quality assurance and Quality Control

● Analyzed management and co-worker feedback

● Worked with management to maintain obese subjects

● Advised management on risk management strategies

● Performs general housekeeping, decontamination and sterilization techniques

● Followed quarantine/acclimation periods and rotation policies

● Facilitated AAALAC accreditation

● Allocated resources

● Verified ID for entry into lab management software

● Formulated diets

● Reduced cross contamination in hallways

● Mentored less experienced colleagues from other departments

● Measuring process parameters

● Improved employee job satisfaction and loyalty

● Expanded the scope of employee engagement

● Provided direct care for study subjects

● Maintained breeding colony production for studies

● Ordered, shipped, received and organized supplies Full-time 40 hours/week

Team Member

Laboratory Technician

July 2000 - December 2004

North Carolina State University

2761 Pillsbury Circle Raleigh, NC 27695

919-***-****

● GDP and GLP environment according to IACUC protocols Certifications

● Worked effectively with scientists, managers and grad students to complete

● Grant based research projects

● PPE

● Attention to Detail

● Resolved cross-contamination problems

● Communicated effectively with management

● Maintained lab equipment

● Collaborated with graduate students

● Quality Assurance and Quality Control

● Performed natural resource and wildlife conservation studies

● Preformed common lab tasks

● Educated community about zoonotic diseases, responsible pet ownership and wildlife care

● Lead, trained and assigned work to new students and temporary staff

● Supported animal health by keeping all areas clean, neat and properly sanitized

● Observed and conducted examinations to identify injury, illness or disease

● Collected physical intake and output data

● Calculated temperature conversions, dosage amounts and dilution rates

● Documented environmental and procedural data

● Initiated results driven interpersonal communication

● MS Word, PowerPoint, Excell

● Species worked with (Aquatics (Hybrid Fish), Voles, Frogs, Avian (Quail, Pigeon), Mearns's grasshopper mouse (Onychomys arenicola), Ground Squirrels, Rats, Mice, Rabbits, Roaches, Mealworms, Fire Ants and Crayfish.

Full-time 40 hours/week

Team Member

Substitute Teacher

March 2000 - June 2000

Durham County Public School System

511 Cleveland St Durham, NC 27701

919-***-****

● Taught Biotechnology, Plant Science, Agriculture Research and Senior Seminar classes

● Set goals

● Proactive behavior modification

● Positive reinforcement strategies

● MS Word, PowerPoint, Excell

● Facilitated student participation to grow and sell plants for school fundraiser

● Administered standardized assessments and documented information in permanent records

● Scheduled parent teacher conferences

● Provided constructive feedback

Full-time 40 hours/week

Team Member

Laborer

May 1998 - February 2000

City of Raleigh Parks and Recreation

222 W. Hargett St. Raleigh, NC 27601

919-***-****

● Maintained, renovated, and landscaped public areas

● Followed state and federal environmental regulation laws

● Provided leadership by training and supervising juvenile offenders (completing community service), new employees and volunteers

● Preformed natural resource conservation

● Restored wetlands and created Riparian zones to prevent erosion contamination

● Inclement weather emergency response personnel

● Obtained my NC pesticide license

Part-time 20 hours/week

Team Member

Farm Intern

August 1996 - August 1998

North Carolina State University

5100 Reedy Creek Rd Raleigh, NC 27607

919-***-****

● Large Animal Research

● Equine Breeding and reproduction

● Farm labor

● Office Assistant

● Assisted with Agriculture Extension Service short courses

● Equine Behavior modification training

Part-time 30 hours/week

Team Member

Sales Associate

May 1991 - April 1998

Lowe's Home Improvement

4601 Capital Blvd Raleigh, NC 27604

919-***-****

● Customer Service Specialist

● Return Desk

● Conflict Management Specialist

● Loss prevention

● Sales transactions

● Stocking merchandise

Part-time 20 hours/week

Team Member

Hostess

January 1990 - August 1991

Red Lobster

4408 Old Wake Forest Rd, Raleigh, NC 27609

919-***-****

● Welcome guests in a warm and friendly manner

● Ascertains their dining/lodging needs.

● Seats guests and manages the seating chart.

● Monitors restaurant activity to determine seating and dining flow.

● Responds to guest inquiries and requests in a timely, friendly, and efficient manner

● Performs opening and closing duties, as needed.

● Assists others with side work including, but not limited to cleaning, stocking, folding silverware, etc.

● Helps fellow team members and other departments wherever necessary to maintain positive working relationships.

Part-time 20 hours/week

Supervisor

Sales Associate

May 1989 - September 1989

Carlton Cards

8845 Six Forks Rd, Raleigh, NC 27615

800-***-****

● Learn new sales methods to boost productivity for my organization

● Communicate with managers and other professionals to learn more about our product

● Listen to instructions from management and senior sales associates to increase my personal output

● Teach new sales associates basic information about the organization and our protocols

● Communicate with customers to find the benefits our products can provide them Part-time 20 hours/week

Team Member

Sales Associate

May 1988 - December 1988

Little Caesars

8323 Creedmoor Road, Raleigh, NC 27613

919-***-****

● Prepared pizza dough and toppings

● Cooked pizzas to perfection

● Ensured a clean and organized workstation



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