Pamela Gronenthal
Platte Center,NE
Summary
Quality minded with robust background in quality control. Known for driving operational efficiency and maintaining standards in experimental processes. Proven team associate with focus on achieving accurate and reliable results, adaptable to evolving project requirements. Multi tasker with minimal supervision, Positive attitude, motivator and works effectively with others.
Overview
29
29
years of professional experience
Work History
Packaging Ops COE, Lead Lab Technician
BD Medical
06.2021 - Current
- Served as a subject matter expert on testing methods for doing tasks, offering guidance to colleagues on best practices in sample analysis.
- Trained and mentored junior technicians, contributing to their professional growth and development.
- Contributed significantly towards maintaining the laboratory's accreditation by consistently upholding high standards in all aspects of work and associates. Created Visual Aids and Documents for any testing needed.
- Ensured accurate test results and attention to detail in sample preparation and analysis.
- Reduced turnaround time for test results by optimizing workflow and prioritizing tasks effectively.
- Maintained a safe and clean work environment by adhering to safety guidelines and protocols.
- Managed inventory levels of consumables, minimizing waste and ensuring uninterrupted laboratory operations.
- Developed comprehensive documentation for laboratory procedures, facilitating, knowledge sharing and performing /maintaining all training for all staff.
- Prepared samples for shipping and disposed of bodily fluids in proper containers.
- Oversaw items in inventory and reordered before supplies diminished.
- Recorded and analyzed data to produce reports of results.
- Participated in lab meetings and project presentations.
- Prepared samples for analysis by performing complex sample preparation tasks.
- Participated in research projects and executing EWO's.
- Cooperated with other technicians to develop and test new protocols.
- Maintained documentation on tests performed in lab.
- Tracked collected specimens by initialing, dating, and noting times of collection.
- Performed testing and quality control using approved laboratory procedures and instrumentation.
- Monitored Quality Notifications for Weekly meeting and helped define ways to reduce Notifications.
- Safety Rep during time on job, Implemented safety concerns throughout
Quality Control Technician
BD Medical
03.2009 - Current
- Maintained quality documentation and records on package and molded parts
- Collaborated with production teams to address, identify and resolve quality concerns, Involvement in several Blitz reducing teams.
- Inspected materials and finished products to verify quality and disposed items that did not meet safety requirements.
- Evaluated samples against standards by completing measurements, visual inspections, and other established tests. Tools used- Computer ( Excel-Input data, Word- Create Charts, Outlook, Adobe, Power Point, MES/SAP/ECC- Usage decisions, blocking and unblocking Inventory, Posting changes, Create Notifications). Microscope/Mantis, Blister thickness gauge, 6" ruler, UDI Test Microscan, Smart Scope, Comparator, Caliper, Copier, Magna Mike, Digital Indicator, Altitude Chamber, Burst tester, Roughness gauge, Carbon Chamber/ change filters, Bow gauge, Drop Gauges Go/No Go, Federal, Air and water leak tester, Harley and Pin Gauges, Retainer, Plunger rod and Barrel leak tester, Chatillon's-break Out Sustain, Shield pulls, Powder test for Silicone, FM Flush test, Shrimpo-Shield, Cannula Barrel, Instron-Blue hill Peel force and Needle Penetration force, Crush test, Understand and use ANSI0ASQ Z1.4.
- Enhanced product quality by conducting comprehensive inspections and identifying defects in a timely manner. Global Hold (Create/ Block/ Release)
- Maintained accurate records of all quality control activities, Archive filing, ensuring easy retrieval for audits ISO, FDA or management inquiries.
- Proposed corrective actions to address recurring quality issues. Created Quality Notifications and Quality Alerts
- Trained new team members signing off on proper quality control techniques. Keep Control spreadsheet to identify when sign off was performed. Train on Documents and update Revisions
- Tested and evaluated product precision against specifications to reduce discrepancies.
- Assisted management in maintaining ISO certification through documentation and protocols.
- Reduced customer complaints by proactively addressing potential issues before products left the facility.
- Worked with production staff to improve processes, reduce defects and improve quality. Compile EWO lot packets and follow thru with any details needed to finish for Engineer or Franklin Lakes
- Conducted regular internal audits to assess compliance with company policies and regulatory requirements, driving continuous improvement efforts.
- Kept up-to-date with industry best practices through C2C
- Monitored calibration schedules for measurement equipment, ensuring consistent accuracy during inspections.
- Conducted thorough root cause analysis for recurring issues, leading to targeted corrective actions and continuous improvement. Worked in Track Wise (Customer complaints)
- Ensured product quality met industry standards by conducting detailed inspections and performing rigorous testing.
- Capable to function in a multi-tasking environment under minimal supervision, completing tasks and sufficient in role. Positive attitude, motivator and works effectively with others.
- Safety Rep 1 year
- Supported development of new product line by providing expert quality control advice
- Reported problems and concerns to management.
- Completed supporting documentation for testing procedures, data capture forms. Generated Certs CoC/CoA, Cert Processor role and Quality Master Data Owner.
Final Auditor
BD Medical
01.1996 - 01.2008
- Coordinated with external auditors as needed. Internal and ISO
- Prepared working papers, reports and supporting documentation for audit findings.
- Prepared audits on product before shipment using ANSI
- Penetration testing using Bolis ( Pig Skin, Stoppers, Polyurethane) & Instron testing (Dental Dam)
- Daily use of Comparator, computer (Email, Excel-Enter info) Copier.
- Support MSA's
- Helped support the growth of the 5- Bevel Needle
- Identify and make decisions on Quality issues
Education
High School Diploma -
Schuyler Central High School
Schuyler, NE05-1984
Skills
- Safety procedures
- Training and mentoring
- Standard operating procedures
- Positive attitude
- Attention to detail
- Team collaboration
- Verbal and written communication
- Multitasker with minimal supervision
Timeline
Packaging Ops COE, Lead Lab Technician
BD Medical
06.2021 - Current
Quality Control Technician
BD Medical
03.2009 - Current
Final Auditor
BD Medical
01.1996 - 01.2008
High School Diploma -
Schuyler Central High School
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