Astride Noncent
Irvington,NJ
Summary
Proven MES Design professional and Quality Assurance Specialist with a track record at Pharmachem for elevating product quality and regulatory compliance through meticulous MES PAS-X system integration and SAP. Leveraged teamwork orientation and technical writing to drive operational efficiencies and foster an inclusive team environment. Achieved notable advancements in aseptic manufacturing processes, ensuring seamless quality assurance and workflow optimization.
Overview
5
5
years of professional experience
Work History
DOCUMENT SPECIALIST II
Stepan
01.2024 - 10.2024
- Schedule and coordinate meetings
- Conduct employee performance reviews
- Develop good customer relationships
- Participate in recruitment and dismissal processes
- Smooth out problems within the workplace
- Address employee and customer concerns
- Develop strategies for better workplace efficiency and goal achievement
- Email and phone correspondence
- Liaise between managers, customers and employees
- Provide direction to staff
- Monitor spending patterns and budget
- Fill in for General Manager (GM) in times of absence
- Make executive decisions, hold meetings and provide accountability
- Troubleshoot POS system
- Support ongoing learning and development of team members
- Help create and foster a respectful and inclusive team environment
- OSHA audit
- Provided assistance with inbound and outbound document processes, document sorting, logging, and work order creation.
- Converted documents from one application to another.
- Collaborated across departments and levels of management to gain consensus on procedural documentation.
- Maintained document control system and updated work instructions, procedures and associated databases.
- Performed document reproduction, printing documents from electronic sources such as email attachments, PDF files and cloud storage.
- Oversaw creation, routing and data input of bills of materials, ECOs, ECRs and ISO documents.
QUALITY ASSURANCE SPECIALIST
American Spraytech
03.2023 - 01.2024
- Proven MES Design professional with extensive experience in implementing and optimizing MES solutions, particularly proficient in PAS-X system integration
- Oversee the creation and maintenance of batch records in compliance with regulatory standards and company procedures
- Ensure accuracy and completeness in documenting each step of the manufacturing process
- Collaborated with cross-functional teams to integrate MES with SAP, contributing to seamless data flow and improved operational efficiency
- Conduct thorough reviews of batch records to verify adherence to Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP)
- Provide approvals for batch records, certifying that products meet quality standards before release
- Played a key role in aseptic manufacturing processes, overseeing the successful execution of MES strategies for enhanced product quality and regulatory compliance
- Specialized in aseptic manufacturing processes
- Skilled in SAP integration, contributing to streamlined operations and enhanced efficiency
- Developed and maintained quality assurance protocols, processes and procedures
- Reviewed customer requirements and specifications to ensure products met standards
- Conducted regular internal audits to identify non-conforming issues
- Performed root cause analysis of defects identified during testing cycles
- Maintained records of all regulatory filings and correspondence
- Collaborated closely with cross-functional teams on product design, manufacturing processes, quality assurance
- Drafted protocols for clinical studies as needed by health authorities for approval purposes
- Reviewed and compiled regulatory documents to ensure compliance with international regulations
- Developed strategies to obtain FDA approval for new products
- Assisted in the preparation of technical documentation for registration submissions
- Coordinated submission of product applications to various regulatory agencies
- Practice good Documentation
- Interpreted regulatory guidelines from multiple jurisdictions and provided advice accordingly
- Provided training on relevant regulations to colleagues within the organization
- Review Batch Record and Work Order
- Produced and filed applications and related documentation for regulatory procedures
- Working knowledge of 21 CFR Part 820, ISO 13485, and EU IVDR
- Used quality monitoring data management system to compile and track performance at team and individual level
- Assisted in defining, refining, and implementing SOPs and internal audit programs
MES DESIGN ASSISTANT / QUALITY ASSURANCE SPECIALIST
Pharmachem
02.2021 - 02.2023
- Experienced MES Design professional assistant with a proven track record in successfully implementing and refining MES solutions
- Demonstrated particular expertise in MES PAS-X system integration
- Engaged in collaborative efforts with cross-functional teams to seamlessly integrate MES with SAP, resulting in improved operational efficiency through enhanced data flow
- Instrumental in the implementation of MES strategies for aseptic manufacturing processes, ensuring the successful execution and contributing to heightened product quality and adherence to regulatory standards
- Recognized specialist in aseptic manufacturing processes, bringing focused expertise to projects and initiatives
- Demonstrated proficiency in SAP integration, making significant contributions to streamlined operations and heightened overall efficiency
- Developed and maintained quality assurance protocols, processes and procedures
- Reviewed customer requirements and specifications to ensure products met standards
- Conducted regular internal audits to identify non-conforming issues
- Investigated customer complaints regarding quality issues and implemented corrective actions accordingly
- Assist in training of other personnel as requested
- Maintain a copy of a master schedule of all studies, including all pertinent information
- Participated in supplier evaluation activities including audits, assessments, and evaluations
- Analyzed quality assurance data to identify trends and develop and implement corrective action plans
- Performed visual inspections of finished products
- Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation
- Received and inspected raw materials
- Completed data capture forms, equipment logbooks or inventory forms to support testing procedures
- Participated in out-of-specification and failure investigations and recommended corrective actions
- Compiled laboratory test data and performed analyses
- Pharma and Food Experience
- Provide Technical assistance MES capabilities and System GMP compliance
- Performed quality control inspections at customer sites to determine alignment with safety regulations
- Maintained knowledge of current industry developments and regulatory requirements for quality assurance purposes
- Collaborated with cross-functional teams across the organization to ensure adherence to quality objectives
- Issue Batch Record, Word order etc
- Maintain SOPs up-to-date
PRODUCTION OPERATOR
Roche Pharmaceuticals
05.2022 - 07.2022
- Performed detailed inspections of incoming materials, ensuring they met the required standards
- Monitored production processes to identify potential areas of improvement
- Follow CGXP quality standards
- Followed detailed work instructions accurately to ensure quality products were produced according to specified standards
- Cleaned equipment and work area before, during, and after shift to promote sanitation
- Operated and maintained production machines to ensure safe, efficient operation
- Employed safety standards and personal protective equipment to reduce workplace injuries or hazards
- Demonstrated excellent problem-solving abilities in troubleshooting equipment malfunctions
LABORATORY TECHNICIAN ASSISTANT
Medlabs
06.2019 - 01.2020
- Assisted with developing new protocols for experiments or procedures
- Conducted quality control tests on incoming chemicals or materials used in the laboratory
- Processed specimens from clinical samples for testing in the laboratory
- Recorded experimental results accurately in a logbook
- Organized and maintained the laboratory environment, including cleaning glassware and disposing of hazardous materials
- Assisted in sample preparation and analysis of data for laboratory experiments
- Troubleshooted technical problems that arose during laboratory procedures
- Maintained an inventory of supplies and reordered as needed
- Disposed of hazardous waste following proper safety guidelines
- Set up experiments according to established protocols, mixing solutions and preparing samples for testing
Education
HIGH SCHOOL DIPLOMA -
Manhattan Comprehensive Night & Day High School
New York, NY08.2012
Skills
- Teamwork Orientation
- Technical Writing
- Document Management
- Workflow Optimization
- Version Control
- Policy Enforcement
- Research Capabilities
- File Management
- Training Development
- Customer Service
- Problem Solving
- Time Management
- Document Conversion
- Content Review
- Microsoft Office Mastery
- Confidentiality Maintenance
- Regulatory Compliance
- Process Improvement
- Multitasking Efficiency
- Data Entry Accuracy
- Attention to Detail
- Workflow Management
- Proficiency in SAP
- Project assistance
- Archive management
- Digital file organization
- Workflow Coordination
- Data logging
- SAP expertise
- Databook preparation
- Invoicing support
- Log updating
- Document Control
- Recordkeeping skills
- Project Support
- Compliance controls
- Data accuracy
- Process Improvements
- Standard Operating Procedures
- Process auditing
- Reporting capabilities
- Document Scanning
- Adobe Acrobat
- Policy Development
- Records Maintenance
- Document retrieval
- Database Management
- Office Equipment Maintenance
- Special projects
- Regulatory controls
- Quality Management
- Document organization
- Records Management
- File conversion
- QMS
- CMM
- ISO 9001
Timeline
DOCUMENT SPECIALIST II
Stepan
01.2024 - 10.2024
QUALITY ASSURANCE SPECIALIST
American Spraytech
03.2023 - 01.2024
PRODUCTION OPERATOR
Roche Pharmaceuticals
05.2022 - 07.2022
MES DESIGN ASSISTANT / QUALITY ASSURANCE SPECIALIST
Pharmachem
02.2021 - 02.2023
LABORATORY TECHNICIAN ASSISTANT
Medlabs
06.2019 - 01.2020
HIGH SCHOOL DIPLOMA -
Manhattan Comprehensive Night & Day High School
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