Denny Kus
Niles,Illinois
Summary
Detail-focused Regulatory and Documentation Specialist with robust background in managing multiple simultaneous projects and ensuring compliance throughout product lifecycle. Proven track record of maintaining high standards of accuracy and meeting accelerated timelines to support customer needs. Known for collaborative efforts and adaptability in dynamic work environments. Proficient in document control, technical writing, and data management.
Overview
10
10
years of professional experience
Work History
Regulatory and Documentation Specialist
BLISTEX, INC.
01.2023 - Current
- Proficient in administration and maintenance of the company's quality EDMS via MasterControl for compliance with applicable regulations and organizational requirements
- Managed multiple high-priority projects simultaneously, ensuring that all deadlines were met without compromising document quality.
- Independently manage project lifecycle and product master files to support validation, raw material qualifications, batch production, analytical testing, product labeling, and release activities of final products.
- Interface with United States and Canada third parties to support and maintain drug listings and registrations for company’s products
- Author, review, and approve high-quality, compliant specifications and regulatory documents throughout product lifecycle
- Demonstrate strong interpersonal and communication skills with internal and external customers to support compilation and submission of documents and records for new product launches
- Working knowledge of FDA USP & Health Canada OTC monographs and cGMP regulations
- SME and primary contact for regulatory questions and requests
- Mentor and train new employees on QMS navigation and processes, documentation review, change control, product lifecycle, packaging & labeling, raw material qualifications, and GMPs
- Proficient change control process and documentation experience utilizing the MasterControl system
- Lead meetings pertaining to project timelines and documentation status updates, artwork review, and special projects
- Demonstrate enthusiasm and initiative with new and improved processes, systems, and products
- Support quality management in regulatory audit activities
- Flexible and adaptable with aggressive timelines, expedited validation activities, and risk management challenges in an ever-changing regulatory environment
Quality Assurance Associate
REGIS TECHNOLOGIES, INC.
04.2019 - 01.2023
- Perform timely review of incoming, in-process, final, and stability analytical data to ensure accuracy and compliance with internal SOPs, test methods, specifications, and CGMP practices
- Inspect and release Manufacturing areas and associated equipment upon completion of strict cleaning procedures succeeding API product manufacturing
- Independently lead and assist management with performing internal audits of data integrity, manufacturing processes, and analytical facilities
- Manage all quality support for method development and validation teams by review and approval of validation protocols, summary reports, test methods, analytical data, validated spreadsheets, document updates, and nonconformances
- Mentor and train new employees across multiple departments on proper change control procedures, GDPs, data and document review
- Organize and track training records for employees across the organization to ensure compliance with department SOPs and project test methods via the uniPoint Quality System
- Proficient change control process experience utilizing the uniPoint Quality System to track, review, and approve controlled documents in an efficient, accurate, and timely manner
- Review and approve analytical data, spreadsheets, and electronic reports via the Chromeleon Data System
- Evaluate and perform trend analysis and generate reports for Quality metrics
- Maintain excellent communication with other key departments to ensure compliance and productive working relationships
- Serve as QA representative in project team meetings and coordinate with project managers and customers to support project needs
- Lead annual CGMP training
- Independently support manufacturing and analytical areas without managerial oversight on 2nd shift
Chemist I
REGIS TECHNOLOGIES, INC.
01.2017 - 04.2019
- Perform analytical testing of incoming, in process, final, and stability APIs according to validated test methods and specifications
- Extensive experience with Chromeleon to run, integrate, and report sample chromatograms
- Independently troubleshoot, service, calibrate, and maintain analytical instruments without direct managerial oversight, such as: HPLC/UPLC, GC, DSC, NMR, Karl Fischer, Potentiometric Titrator, and Particle Size Analyzer
- Proficient with prep-and-shoot and weight percent sample preparation for HPLC analyses
- Perform accurate, legible, contemporaneous, and complete documentation of all analytical testing on tracked laboratory worksheets and notebooks
- Maintain chemical inventory of the Quality Control lab and track inventory movements via the SYSPRO Inventory Management System
- Perform peer review of analytical worksheets and electronic reports
- Train new chemists
- Assure all practices and procedures are consistent with CGMP guidelines and internal requirements and regulations
Chemist I
ABBVIE INC.
03.2015 - 12.2016
- Analyse incoming, in process, and stability pharmaceuticals according to standardized test methods by GC, UV, FTIR, Karl Fischer, and other USP/EP methods
- Incorporate strict and accurate documentation of methods and results in tracked laboratory worksheets
- Efficiently organize and complete all testing of incoming pharmaceutical products within the scheduled time frame and incorporate scheduling flexibility to accommodate frequent expedite and time-dependent sample testing
- Work effectively in a team environment in order to ensure accurate and efficient testing of pharmaceutical products
- Enter completed test results in SAP and ThermoLIMS Data Entry Systems
- Familiar with Empower Processing System to run and integrate sample chromatograms
Education
Master of Science - Regulatory Affairs and Quality Assurance
Temple University, School of Pharmacy
Philadelphia, PA05.2025
Bachelor of Science - Chemistry
Eastern Illinois University
Charleston, IL05.2014
Skills
- Microsoft Office
- QMS (uniPoint, MasterControl)
- ERP (SAP, ThermoLIMS)
- CDS (Chromeleon, Empower)
- Good Manufacturing Practices
- 21 CFR Food & Drugs
- ICH Q7, Q8, Q9, Q10
- Project Management
- Time Management & Multitasking
- Excellent Communication & Interpersonal Skills
- Adaptability & Flexibility
- Training & Mentoring
- Continuous Improvement
- Organizational Skills
- Validation & Method Development
- Attention to Detail
Affiliations
- Member of Regulatory Affairs Professional Society (RAPS)
- Member of American Association for the Advancement of Science (AAAS)
Awards
Recipient of Blistex Winner's Circle Award for Core Value: Fast Moving and Continuously Improving
Timeline
Regulatory and Documentation Specialist
BLISTEX, INC.
01.2023 - Current
Quality Assurance Associate
REGIS TECHNOLOGIES, INC.
04.2019 - 01.2023
Chemist I
REGIS TECHNOLOGIES, INC.
01.2017 - 04.2019
Chemist I
ABBVIE INC.
03.2015 - 12.2016
Bachelor of Science - Chemistry
Eastern Illinois University
Master of Science - Regulatory Affairs and Quality Assurance
Temple University, School of Pharmacy
Similar Profiles
Noah FelicianoNoah Feliciano
Stock Handler at BlistexStock Handler at Blistex
Luis GarayLuis Garay
Material Handler at BlistexMaterial Handler at Blistex
Bonnie GibbsBonnie Gibbs
Warehouse Packer at BlistexWarehouse Packer at Blistex
Daniela SilvioDaniela Silvio
Volunteer at Niles-Maine District LibraryVolunteer at Niles-Maine District Library
Karen SimionKaren Simion
Customer Service Representative at Miller-Stephenson ChemicalCustomer Service Representative at Miller-Stephenson Chemical