Quality Manager Project

Nancy E. Astephen

Mendon, MA ******.**@*****.*** • 508-***-**** • LinkedIn

Trusted Quality Manager at a certified CCC Lab, within MA, with previous experience in the health field as a Practice Coordinator - Ambulatory Admin - Med Ops Role in Pediatric Medicine –Past role as internal sales representative maintaining excellent communication skills. Past Principal Project Manager with extensive implementation management experience. Significant technical and medical background in large-scale projects for on- and offshore programs. A unique combination of both technical and customer savvy in service and sales. Innovative project leader focused on quality and process improvement for analytical system solutions, software, and services across Pharmaceutical, biochemical, industrial, nutritional safety, environmental, academic, and governmental marketplaces. Well-regarded as a collaborative and detail-oriented professional who listens deeply and executes plans.

Profile

Leadership & Mentoring

Cross-Functional Communication

Vendor Management

Strategy & Project Planning

Risk Mitigation

Quality Management

Data Visualization

HIPAA Compliance

Certified Epic Experience

Professional Experience

ProVerde Laboratories Current

Quality Manager - maintains and continuously improves upon the QA function to ensure compliance with industry regulations and certifications, facilitating the implementation of QA best practices within the organization. In addition, plan and coordinate all QA activities and personnel, accommodating requests for quality support and communicating the policies and procedures in support of the organization. Maintain compliance with ISO 17025 including document control, employee training, internal and external audits, CAPA, and Total Quality Management (TQM). Ensure all testing and procedures are properly understood, carried out, and evaluated and that service modifications are investigated if necessary. Maintain supplier relationships to ensure all suppliers meet quality requirements and make changes when identified

Tufts Medical Center December 2022

Administrator Coordinator – Dr Eli E Rebeiz Department of Otolaryngology-Head and Neck Surgery

Communication with the Director, Physician, and Nurse practitioner to ensure we provide an overall great patient experience while following HiPAA.

Scheduling surgery, CT, MRI, and collaborative doctors with neurosurgery. Maintain schedule for clinics with routine phone support, faxing, and ensuring medical records were up to date and available upon request.

Ambulatory Practice Coordinator – Float pool

Assigned to Pediatrics Neurology Department

Support refills, prior authorizations, EEG orders, Seizure Action Plans, routine faxing, phone support, and scheduling appointments.

Act as a focal point in the department for the remaining physicians. Communication with patients regarding Tufts Pediatrics Neurology Department closure and options for continued service of their children at an alternative provider, based on their insurance.

Create smooth processes in a fast-paced environment. Communication with the Director, Physician, and Nurse practitioner to ensure we provide an overall great patient experience even though the transition has been evolving with the department's closure in November 2022.

Cross-training the new Medical Assistant on the phone, seizure action plans, scanning, and requesting patient refills. Ongoing meetings with the director and physician for planned actions moving forward and sharing with the team.

Newborn Administrative Role -Float Pool

My focus was to schedule babies with follow-up appointments at the NICU Follow-Up Clinic. This clinic is for babies with low birth or premature babies to access development. Scheduling and rescheduling depending on clinics creating reminder letters, and confirming upcoming appointments.

Checking In/Outpatients, while communicating with the front desk on legal name changes, discussing unique family situations, foster parents, adoptions, and sharing with therapists. Using language lines for effectively communicating with the parents.

Establishing communications with Neonatal doctors/fellows within Neonatology for Prenatal consultations with Maternal Fetal Medicine. Solidified a process that has been a challenge for three years. This was a meeting with cross-functional physicians meeting together with neonatologists and other departments.

Establishing the meeting with the expecting mother is to ensure health concerns and corrective actions for a successful birth and establish corrective measures for the child.

IT ticket resolution regarding tagging patients who have passed. Shared with a float team to allow

updating demographics on patients throughout the hospital who were in the system not tagged as deceased. PowerPoint presentation on workflow processes while cross-training new personnel

Renewal by Anderson

Telefluent Communications Inc - Northborough, MA

Inside Sales Representative 2020 – 2022

Providing homeowners with excellent communication skills, embracing the Mission statement of Integrity/ Love while assisting people. Consistently maintaining excellent overall metrics as required by the department.

Ambassador of Love recognition– June 2021

Recognition multiple times for top demo sales

Waters Corporation – Milford, MA

Principal Project Manager 2017 to 2020

Coordinated cross-functional and successfully executed solutions for New Key Product Development for Waters Global Services, specializing in comprehensive results on contamination problems. Created internal internet communities, layouts, and structures. Ensured all projects were on time, and within scope and budget. Managed the stocking of three distribution centers.

Selected Contributions:

Implemented an initiative that resulted in our liquid chromatography/mass spectrometry (LC/MS) systems solvent kits becoming standard within the variant (cutting installation time in half) in 65 countries including Latin America, South Africa, Europe, and Asia.

Implemented the Clean Solvent Initiative based on metrics identifying the most prevalent causes of failure and delay during installations, saving the company $454 a day.

Increased field efficiency by designing an online contamination training module for field service engineers and customers.

Generated $1M in additional revenue since 2015.

Success and Business Collaborate 2014 to 2017

Coordinated third-party support agreements and service business relationships for external products, supported as part of Waters product offerings, such as LEAP, CTC, Tecan, Gilson Spark Holland, Peak Scientific, Edwards, and Pfeiffer. Developed project scope and objectives, involving all relevant stakeholders, to ensure technical feasibility; managing all changes to scope, schedule, and costs.

Selected Contributions:

Collaborated globally with teams across Asia, Europe, and the U.S. to commercialize PerkinElmer Health Sciences’ privately labeled instrumentation, increasing revenue by $40M in 6 months.

Implemented the Clean Solvent Initiative based on metrics identifying the most prevalent causes of failure and delay during installations, saving the company $454 a day

Service and Support Manager 2007 to 2014

Led the development of a strategy for the Global Support team to ensure quality service for LC/MS system and purification solutions as well as supercritical fluid chromatography and extraction (SFC/SFE) instrumentation and related applications. Developed comprehensive project plans to share with stakeholders and staff to certify timely reporting and proactive communication. Key product initiatives included convergence chromatography, bio botanical cannabis, and ionKey/MS.

Selected Contributions:

Managed internal interaction with all corporate departments (primarily global field operations, quality assurance, product management, and development) as well as the integration of acquired company Thar in 2010.

Designed and integrated a contamination/carryover reporting portal site for field engineers.

Developed a contamination-free bottle kit specific to ionKey/MS systems in collaboration with ERA personnel.

Principal Support Engineer 2005 to 2007

A resource to support LC/MS systems and qualification. Collaborated with field engineers and customers to resolve product/application issues, assisting field operations with installation and troubleshooting.

Selected Contributions:

Developed the Alliance/ACQUITY ultra-performance liquid chromatography (UPLC) system bottle kit, resulting in $1M additional revenue.

ADDITIONAL EXPERIENCE

Micromass, UK (Acquired by Waters in 2002) Led Global Service Introduction to merge the service business practices between US and UK locations

Senior Support Engineer

Thar, Pittsburgh, PA (Acquired by Waters in 2011) Structured Support Services. Developed Intranet location for materials inclusive of training strategies

Manager, Technical Support Group

•• ••• ••

Additional roles included Senior Support Engineer, Senior Development Engineer, Evaluations Specialist, Life Science Marketing Lab Specialist, and Customer Support Specialist.

Educational Background

Bachelor of Science Degrees, 1983 Medical Technology

1982 Biology & Chemistry

Salve Regina University, Newport, RI

Department of Pathology Diploma 1983

St Joseph Hospital –School of Medical Technology

Technical proficiencies

Microsoft Office 365, Visio and Project, IBM (internal communities), Sametime, Snagit, Business Warehouse, amino acid analysis, volatile organic compounds (VOC), hematology, high-performance liquid chromatography (HPLC), UPLC, immunology, protein purification, ion exchange, peptide analysis, mass spectrometry, capillary electrophoresis, convergence chromatography, contamination mitigation, SFC/SFE, EPIC Certified, HIPPA, CPR Certified

Certifications

Measuring Instruments of the People’s Republic of China, General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) Certification for ACQUITY UPLC SYSTEM, Project Management Institute, Time Management, Business Writing, Conflict Management, Facilitation, Leadership for Success, Delegating Accountability, Communication, Motivation, Coaching Inside, Situational Leadership, Leading Change, Essentials of Management Complaint Handling, Train the Trainer, PMI Conference’s, Wellforce EPIC – ECP-PRD1, Qualtrax / Ideagen Quality Management System

Publications and Awards

Astephen, N., Wheat, T.E., An Amino Acid Analysis Method for Assessing Nutritional Quality of Infant Formulas, American Lab, February 1993

Young, P.M., Astephen, N. and Wheat, T.E., Effect of pH and Buffer Composition on the Separation of Peptides by High-Performance Liquid Chromatography and Capillary Electrophoresis, LC.GC, Vol.10, Number 1, 26 32,1992

Wheat, T.E., Young, P., and Astephen, N.E., Use of Capillary Electrophoresis for the Detection of Single Residue Substitutions in Peptide Mapping, J. Chrom, December 13, 1990

Warren, W., Astephen, N. E. and Wheat, T.E. Systematic Optimization of Protein Separations on High Performance Ion Exchange Media, J. Chrom, 512, 13 22, 1990

Wheat, T.E., Young, P.M., Astephen, N.E., Application of Capillary Electrophoresis to Some Common Problems in Protein and Peptide Biochemistry, Biotech USA Conference Proceedings, November 27 29, 1990

Burgoyne, R., Stacey, C., Young, P., Astephen, and Merion, M. Analysis of Peptides at Low Levels Using a Chromatography System Optimized for Narrow Bore Columns, Techniques in Protein Chemistry, Ed. T.E Hugli, 1989

CERTIFICATE OF APPRECIATION: Center for Food Safety and Applied Nutrition FDA

AWARDS FOR EXTRAORDINARY EFFORTS: Received 15+ project, process, and audit awards including Clean Solvent Initiative, ALTUS Project, BONN Project, and ACQUITY UPLC SYSTEM Program

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