LaJoyce Collins
Berlin,NJ
Summary
Experienced Quality Control Leader | Driving Excellence in cGMP Settings
With over two decades of technical and analytical laboratory expertise within cGMP environments, including six years in lead or supervisory roles, I bring a wealth of experience to the table. As a resourceful team player, I am committed to achieving company goals while fostering collaboration and cohesion within teams.
I excel as a Quality Control Inspector, conducting meticulous inspections, assessments, and reporting on quality issues. My track record includes spearheading initiatives that have significantly enhanced production through quality control improvements. I thrive on partnering with production teams to identify and rectify negative trends, driving continuous improvement throughout operations.
As a well-qualified Quality Control scientist, I am proficient in documentation, reporting, and compliance standards. My methodical approach, coupled with a deep understanding of manufacturing and production operations, enables me to ensure adherence to the highest quality standards while optimizing efficiency and productivity.
I am eager to leverage my expertise to contribute to the success of a forward-thinking organization within the pharmaceutical, medical device, or biomedical industries, where my dedication to quality and drive for excellence can make a tangible impact.
Overview
23
23
years of professional experience
Work History
Senior Scientist, Quality Control
Menarini Silicon Biosystems
04.2017 - Current
- leadership as a Quality Control supervisor backup, ensuring seamless operations in the absence of the supervisor.
- Instrumental in prioritizing project tasks in alignment with manufacturing department objectives, optimizing workflow efficiency.
- Proficiently operates instrumentation for the enumeration and characterization of rare circulating tumor cells via immunogenic selection, notably CellTracks technology.
- Conducts comprehensive release testing of in-process bulk, incoming materials, stability, and finished goods utilizing a diverse array of instrumentation, including FACSCalibur Flow cytometer, Anatel and Shimadzu TOC, UV/VIS, Osmometer, Particle and cell Counters, hematology analyzer, pH meter, plate reader, Bio-Burden, Arber press, Celltracks Autoprep, and Celltracks Analyzer II.
- Proactively supports and maintains the QC Laboratory and supplies, ensuring uninterrupted operations and optimal resource utilization.
- Performs routine equipment maintenance, guaranteeing instrument accuracy and reliability for precise testing outcomes.
- Reviews and validates completed QC-generated test documents, ensuring accuracy and compliance with established protocols.
- Manages the tracking of passing and failed test results for finished and raw materials via SAP, facilitating data-driven decision-making and process optimization.
- Acts as a backup for performing water quality, Lab EM and micro testing, maintaining regulatory compliance and quality assurance standards
- Provides comprehensive training to QC analysts on all functions at the Huntingdon Valley facility, nurturing talent and ensuring proficiency in critical operational areas.
- Collaborates closely with cross-functional teams to address non-conformance issues, implementing corrective actions promptly to maintain product quality and compliance.
- Initiates and executes Change Requests via Documentum, driving continuous improvement initiatives and ensuring SOPs reflect best practices and regulatory requirements.
- Contributes to securing funding for critical research initiatives through collaboration with external partners, ensuring sustained financial support for key projects.
- Demonstrates a steadfast commitment to health and safety regulations, particularly in the handling of dangerous or toxic substances, prioritizing employee well-being and environmental stewardship.
Co-Owner/Operator
HOODGRIND Apparel
08.2019 - Current
- HOODGRIND stands for Hands On Our Dreams Give Receive Innovate Navigate Destiny.
- We sell top quality street/casual wear that remind kids and those of us who are kids at heart to innovate as you navigate toward your dreams.
- Give back and receive from our community as we all grind to make our neighborhoods better than how we found it.
- Our clothes reminds you to Hold on to those dreams when you get back up when life knocks you down.
- Interacted well with customers to build connections and nurture relationships.
- Collaborated with co-owner to develop strategic plans for business expansion and increased profitability.
- Delivered services to customer locations within specific timeframes.
- Proved successful working within tight deadlines and a fast-paced environment.
Quality Control Scientist II
Janssen Diagnostics, LLC
05.2012 - 03.2017
- Operates instruments in the enumeration and characterization of rare circulating tumor cell via immunogenic selection (CellTracks)
- Performs release testing of in-process bulk, incoming materials, stability and finished goods using the following instrumentation:
- FACSCalibur Flow cytometer, Anatel and Shimadzu TOC, UV/VIS, Osmometer, Particle and cell Counters, hematology analyzer, pH meter, plate reader, and Bio-Burden, Arber press, Celltracks Autoprep and Celltracks Analyzer II
- Supports and maintains QC Laboratory and supplies
- Performs routine maintenance of equipment
- Reviews completed QC generated test documents
- Change Author and reviewer in DocSpace
- Documents investigations via NICE (Trackwise)
- Track passing and failed test results of finished and raw material via SAP
- Performed and reviews monthly water quality testing using approved microbiologic techniques
- Trains new QC analysts on all QC functions at the Huntingdon Valley facility
- Along with Management, responsible for speaking for QC during audits
- Document coordinator for the “front room” during audits
- Communicated with production team members about quality issues.
- Identified and documented quality discrepancies for management to develop resolutions.
- Participated in team meetings to discuss progress and results, providing ideas and suggestions for improvement.
- Inspected raw materials and finished products to verify quality and disposed items that did not meet safety requirements.
- Conducted investigations into questionable test results.
- Established effective communication channels between departments to facilitate a collaborative approach to problemsolving.
- Collaborated with cross-functional teams to resolve product issues and implement corrective actions.
- Maintained compliance with industry standards through diligent documentation and recordkeeping.
- Assessed products or services to evaluate conformance with quality standards.
- Inspected incoming and outgoing materials for accuracy and quality.
- Inspected quality of products, taking note of functionality, appearance and other specifications.
- Performed root cause analysis to identify and resolve defects, improving quality standards.
- Performed visual inspections and non-destructive tests where appropriate.
- Participated in team projects, demonstrating an ability to work collaboratively and effectively.
- Demonstrated respect, friendliness and willingness to help wherever needed.
- Developed and maintained courteous and effective working relationships.
- Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
Lead Testing Technologist, Laboratory Supervisor, Laboratory Technologist
06.2001 - 10.2011
- Infectious Disease Lab
- Reviewed test runs, maintenance, quality control, and proficiency testing
- Verified staffs testing by review of documentation for accuracy, validity and completeness
- Confirmed assay procedures were in compliance with the Code of Federal Regulations, kit inserts, and work instructions
- Identified test errors, equipment problems, and potential issues that may adversely affect test performance or results
- Troubleshooter and implemented corrective actions
- Investigated assays that yielded unusual or unexpected results
- Provided proper investigation documentation
- Ensured immediate corrective actions were taken to resolve invalid or suspect tests
- Provided on-site, telephone or electronic consultation to resolve technical problems in accordance with established policies and procedures
- Supervised workflow and shift scheduling
- Oversaw staff compliance to safety policies and procedures
- Prioritized lab workflow to meet company goals to satisfy client demands for accurate and timely test results
- Implemented procedural changes to laboratory testing via training
- Made sure staff complied with regulations, directives, work instructions and local policies
- Maintained reagents, equipment and supply inventory
- Performed the following assays on blood donation samples and contracted customers: PROCLEIX ULTRIO and PROCLEIX WNV Assay via Novartis TIGRIS ORTHO T
- Cruzi and HCV ELISA Test System HBCore, HBgAG, HTLV-1/HTLV11, and HIV-O Plus via Abbott PRISM System Triglyceride via Bio Rad
- Performed the following assays on blood donation samples and contracted customers:
- ELISA and EIA testing for anti HIV ½, HBsAg, anti-HBc , anti HTLV I/II, HemoCue Plasma/Low Hb
Education
No Degree - Green Belt - Lean Six Sigma And Project Management
Rutgers Camden School of Business
Camden, NJ07.2012
Intro to Forensics -
Camden County College
Blackwood, NJ2004
No Degree - Phlebotomy
Atlantic County Vocational & Technical School
Mays Landing, NJ06.1997
B.A. - Chemistry
Lake Forest College
Lake Forest, IL1995
Skills
- cGMP
- ISO 13485
- Quality Inspection and Control
- Document Control
- Process Validation
- Root Cause Analysis
- Lab Equipment Maintenance
- Laboratory Management
- Equipment Maintenance
- Equipment Testing and Calibration
- Micro testing
- Cell Culture Techniques
Accomplishments
- Notary Public State of New Jersey - January 2011- Present
- New York Fashion Week at Sony Hall - 2022
- Top 100 Fab Leaders- FABCon 2020
- Bethany Baptist Church –Multi Media Ministry (Tape Duplication, Video Controller, and Character Generator)
- American Association of Blood Banks – assessor for the AABB Accreditation Program December 2013 – June 2015
Timeline
Co-Owner/Operator
HOODGRIND Apparel
08.2019 - Current
Senior Scientist, Quality Control
Menarini Silicon Biosystems
04.2017 - Current
Quality Control Scientist II
Janssen Diagnostics, LLC
05.2012 - 03.2017
Lead Testing Technologist, Laboratory Supervisor, Laboratory Technologist
06.2001 - 10.2011
No Degree - Green Belt - Lean Six Sigma And Project Management
Rutgers Camden School of Business
Intro to Forensics -
Camden County College
No Degree - Phlebotomy
Atlantic County Vocational & Technical School
B.A. - Chemistry
Lake Forest College
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