Summary
Overview
Work History
Education
Skills
Professional Memberships
Timeline
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Mary Jordan Ward

Lillington,NC

Summary

Detail-oriented, organized and meticulous employee. Works at fast pace to meet tight deadlines. Enthusiastic team player ready to contribute to company success.

Overview

10
10
years of professional experience

Work History

Laboratory Validation Engineer

CAI
06.2022 - Current
  • Performs Analytical Instrument Qualification Activities for client's large QC Project
  • Analytical Instrument Qualification Involvement included but was not limited to: Non-Viable Particle Counters, Microbial Air Samplers, rFC Endotoxin Plate Readers, Pipettes, Thermal Cyclers, Centrifuges, and Osmometer
  • Writes, develops, and executes qualification protocols in KNEAT Validation software
  • Documents include but are not limited to: Installation Qualification, Operational Qualification, Performance Qualification, Software Installation Verification Instruction, Test Problem Reports, Qualification Summary Report, Post Maintenance Qualification
  • Writes, reviews, and revises a variety of Installation, Operation and Performance qualification/verification related documents, including all the following: Qualification Plans (QP), User Requirements (URS), Design Verifications (DV), Computer System Design Verifications (CSDV), System Overview and Configurations (SOC) as well as Computer System Validation Summary Reports
  • Prioritizes client's needs to deliver activities as required to meet the schedule
  • Track progress of instrument qualification processes and communicates directly with client to maintain full transparency throughout all qualification activities
  • Coordinate with project contractors and equipment vendors to gather essential information on equipment as to ensure that client's user requirements are met through both initial qualification and all PM/Calibration activities in the future
  • Coordinates installation of new analytical instruments with both vendor and Performed Computer System Validation activities relating to various instruments using several software systems such as: MODA for EM Sample Collection and Non-Viable Particle Counter Data Transfer, WinKQCL and MODA for Endotoxin test result export, MicroSEQ/Data Collection
  • Acted as a consultant on Pharmaceutical Compressed Air (PCA) PQ for both QC Laboratory and Manufacturing to assist in the successful qualification of multiple PCA lines.
  • Optimized engineering processes by implementing innovative solutions and streamlining workflow.
  • Coordinate cross-functional efforts to successfully implement new technologies into existing systems.
  • Evaluates vendor proposals for equipment procurement, selecting optimal solutions based on performance requirements.
  • Established strong working relationships with clients through exceptional communication skills, fostering trust and collaboration.

Environmental Monitoring Technician II/Associate Scientist I

Alcami Corporation
03.2021 - 05.2022
    • Maintained working knowledge of instrumentation, equipment, and scientific methodologies necessary to perform assigned tasks
    • Isolated and made cultures of bacteria or other microorganisms in prescribed media, controlling moisture, aeration, temperature, and nutrition
    • Examined physiological, morphological, and cultural characteristics, using microscope and other relevant equipment, to identify and classify microorganisms in test articles
    • Managed the incubation of samples, plate reading and reporting of results
    • Accurately completes GMP reviews as assigned
    • Led Junior Technicians in Laboratory Reorganization/5s Projects throughout Alcami facilities
    • Performed Endotoxin and Bioburden testing
    • Maintained lab stock of microbial cultures
    • Interacted with clients
    • Reviewed and revises procedures as requested
    • Participates in company training and maintained status of certifications
    • Provided technical training and leadership for support level technicians
    • Assisted in sustaining of the laboratory safety and cleanliness by maintaining inventory, disposal of waste and routine cleaning of laboratory rooms and equipment
    • Ensured required testing documentation is complete and generated with adherence to company policies and procedures
    • Ensured timely completion and compliance with cGMP and all other relevant company training requirements
    • Performed sampling of air for viable and non-viable particle counts along with contact surface testing
    • Performed sampling and testing of facility gasses and water including pre-treatment, USP and Water for Injection
    • Escalated to management any failures and concerns related to environment of controlled spaces
    • Understands and utilized MODA system, MasterControl, various Microsoft office applications
    • Trained junior technicians
    • Involved in External Environmental Monitoring Program (Jul2021-May2022)
    • 6 external projects on client sites involving cleanroom qualification/requalification (EMPQ), compressed gas sampling, Viable Air testing, Viable Surface testing and Non-viable Air testing
    • Participated in Alcami Phase II EMPQ (protocol writing/mapping)
    • Participated in Alcami Phase II EMPQ water testing
    • Received 2 Alcami Mindset Spot Awards
    • Received Alcami Mindset Excellence Award.

QC Technician I- Environmental Monitoring Sampling

Novo Nordisk Pharmaceuticals
07.2019 - 03.2021
    • Maintained classified production areas by performing routine environmental monitoring
    • Supported production with non-routine sampling
    • Provided oversight of contract sanitization group
    • Utilized PEMS system to create labels, collect and submit EM samples
    • Operated air samplers to perform viable and non-viable air monitoring
    • Collected water samples
    • Took gown certification samples
    • Developed 3 Process Improvements/Continuous Improvements that were implemented by Quality Control and Aseptic Production
    • Completed cLEAN-1 Star training
    • Other accountabilities as assigned.

Pharmaceutical Recruiter-Associate Consultant

Barrington James
12.2018 - 07.2019
  • Present potential candidates to clients for their open positions and coach them through entire /hiring process.
  • Increased candidate placements by developing and maintaining relationships with clients and candidates.
  • Enhanced recruitment process for faster hiring by utilizing various sourcing tools such as job boards, social media, and networking events.
  • Streamlined communication between candidates and hiring managers, leading to higher satisfaction on both sides.
  • Provided exceptional customer service to both candidates and clients, fostering long-term partnerships.
  • Managed high-volume requisitions in a timely manner to meet client staffing needs efficiently.
  • Implemented innovative sourcing strategies that led to the discovery of top talent in competitive markets.
  • Negotiated competitive salary packages with candidates, resulting in successful offers and acceptances.
  • Developed strong understanding of industries served, allowing for targeted recruiting efforts for specialized positions.

Server

Sportszone
11.2017 - 12.2018
    • Enhanced customer satisfaction by promptly attending to their needs and providing personalized service.
    • Maximized table turnover rate by efficiently managing reservations and seating arrangements.
    • Collaborated with team members during busy shifts for efficient workflow and excellent guest experiences.
    • Demonstrated strong multitasking skills by managing multiple tables simultaneously without compromising service quality.
    • Increased sales with upselling techniques and thorough knowledge of menu items, specials, and promotions.
    • Maintained a clean and orderly dining area for an enjoyable guest experience.
    • Coordinated with kitchen staff to ensure timely delivery of orders, resulting in satisfied customers.

Teaching Assistant/ Assistant Lab Instructor for Zoology Labs

Campbell University
08.2017 - 12.2018
  • Collaborated with fellow teaching assistants to create a consistent and supportive learning environment for students.
  • Provided one-on-one tutoring sessions for struggling students, leading to increased understanding and improved grades.
  • Offered constructive feedback on student assignments, helping them refine their writing skills and comprehension.
  • Evaluated student performance through regular assessments, tracking progress and adjusting instructional strategies as needed.

Assistant to Associate Professor of Biology

Campbell University
08.2017 - 12.2018
  • Proctored exams
  • Scheduled meetings
  • Organized class information
  • Graded papers/exam

Server

Western Sizzlin Steakhouse
06.2014 - 11.2017
  • Enhanced customer satisfaction by promptly attending to their needs and providing personalized service.
  • Maximized table turnover rate by efficiently managing reservations and seating arrangements.
  • Increased sales with upselling techniques and thorough knowledge of menu items, specials, and promotions.
  • Maintained a clean and orderly dining area for an enjoyable guest experience.
  • Assisted in training new hires, providing guidance on restaurant standards and best practices.
  • Demonstrated strong multitasking skills by managing multiple tables simultaneously without compromising service quality.
  • Provided attentive service during high-volume periods without sacrificing attention to detail or guest rapport.
  • Adhered to proper food handling procedures and safety guidelines for the well-being of guests and team members alike.
  • Implemented effective communication strategies between front-of-house and back-of-house staff for streamlined operations.

Education

Bachelor of Science in Biology -

Campbell University
Buies Creek, NC

Skills

  • Extensive cGMP, GDP and GLP knowledge
  • SME in Aseptic Processes ISO standards and Aseptic Conduct
  • Detail Oriented
  • Kneat Validation Software
  • MODA
  • Computer System Validation
  • EMPQ/Utility PQ
  • Viable and Non-Viable Sampling/Environmental Monitoring
  • Endotoxin/Bioburden
  • Technical Writing
  • System Troubleshooting
  • Quality Control

Professional Memberships

Varsity Athletics: Women's Lacrosse, 07/2012–05/2013, Team was involved in Kid's on the Run program designed to encourage a healthy and active lifestyle for elementary age children. Represented Campbell University Athletics by being on the Division 1 Inaugural Lacrosse Team.

Timeline

Laboratory Validation Engineer

CAI
06.2022 - Current

Environmental Monitoring Technician II/Associate Scientist I

Alcami Corporation
03.2021 - 05.2022

QC Technician I- Environmental Monitoring Sampling

Novo Nordisk Pharmaceuticals
07.2019 - 03.2021

Pharmaceutical Recruiter-Associate Consultant

Barrington James
12.2018 - 07.2019

Server

Sportszone
11.2017 - 12.2018

Teaching Assistant/ Assistant Lab Instructor for Zoology Labs

Campbell University
08.2017 - 12.2018

Assistant to Associate Professor of Biology

Campbell University
08.2017 - 12.2018

Server

Western Sizzlin Steakhouse
06.2014 - 11.2017

Bachelor of Science in Biology -

Campbell University

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Mary Jordan Ward