Experienced food, pharmaceutical/biotech quality professional with 8 years experience and comprehensive knowledge of all applicable GLP, and cGMPs requirements. Fully cultivated and compliant of SOPs, cGMPs, SQF, HCAAP & OSHA standards. Dedicated individual with interpersonal, communication, and time - management skills. Ability to work independently as well as in a team environment. Proficient in all disciplines of current manufacturing operations and packaging operations including: safety; quality and lean manufacturing processes; vial and syringe immunizations; blood transfusion immunotherapy. Thorough knowledge of FDA regulations and practices.
COMPUTER SKILLS INCLUDE:
Oracle Production ERP, Excel, Outlook, SAP, PowerPoint, Acrobat, LabWare LACES LIMS, Word, Access, Novell and Internet Applications.
Confidential, Elmsford, New York
Quality Assurance Coordinator
- Perform receiving inspections and conduct testing on raw ingredients for moisture, particle analysis chemical composition and components
- Inspect products on manufacturing line for flaws or defects.Ensure production process meets industry standards.Improve upon materials and parts used in production process.
- Create reports of quality control tests and analyze the data to determine if any changes in the production process are necessary.
- Develop and implement quality improvement activities and policies.
- Fulfill documentation and reporting requirements for the Quality Management program. Develop performance improvement targets for quality, service, and efficiency.
- Develop educational materials including trainins procedures.
- Perform statistical analysis and data analysis.
- Assist with quality control audits.
- Investigate, monitor, document and report on quality of care and service issues.
Confidential, Orangeburg, New York
Quality Assurance Coordinator
- Perform daily inspections on finished goods and machinery as well as collecting samples for Micro and Analytical analysis.
- Review and prepare specifications for manufacturing production.
- Carry out Non - Conformance Report on products out of spec and prepare CAPA
- Review liquid batches for miscalculation, omission of entries and good documentation practices.
- Perform AQL on products out of compliance
- Conduct internal auditing to ensure compliance of all GMP and following SOPs
Confidential, White Plains, New York
R&D Quality Tech, Implementation Specialist
- Support the R&D Quality Teams in the realization of the Scarlett project - Assess, gather and assemble the necessary information in SAP s Artemis tool
- The acting resource person in the Scarlett project - interacts with suppliers and internal partners from R&D, Quality, SSD and with Regulatory.
- Analyze the status of ingredients and / or pack in Artemis
- Made requests for Food Safety Visas (FSV) that don t currently meet requirements in terms of format or when missing for ingredients and pack material items and validates information.
- Write up missing specifications: defines the specifications for ingredients & packaging, in consultation with R&D / Quality personnel in order to align & comply to production lines and best practices
- Assembled FSVs, specifications for ingredients and packaging material items in Artemis system.
- Help support all departments with implementing the GO LIVE of the new tool for global purchasing through DanTrade.
- Performed daily report to N+1 on job evolution
Confidential, Brooklyn, New York
Lab Analyst for Process Development
- Reorganized and prepped the Process Development lab for drug manufacturing.
- Completed documentation to update manufacturing procedures (SOPs).
- Setup, operated and maintained various equipment in a Process Development Lab (PDL) such as Bio - Safety Cabinets (BSC), incubators, refrigerators and freezers, pipettes etc.
- Maintained calibration and documentation of equipment, inventory of materials, and data analysis spreadsheets.
- Performed mononuclear cell purification, induction, and virus filtration.
- Edited Standard Operating Procedures (SOPs) and performed equipment validation protocols.
- Abided by GLP and GMP Standards with performing SOPs of equipment and processes.
- Collaborated with Quality Assurance and Quality Control departments to complete projects and documentation, including review of QC data, and data analysis.
Confidential, Morris Plains, New Jersey
- Aseptic GMP manufacturing of clinical and commercial human blood therapeutics in a clean - room environment with biological safety cabinets clean rooms class ISO 5/class 100.
- Perform Oracle Production ERP functions, weighs, measures and checks raw materials to ensure batches manufactured contain proper ingredients and quantities.
- Maintains records and clean room environment to comply with regulatory requirements, good manufacturing practices and aseptic processing of clinical and commercial products using Standard -Operating Procedures.
- Train new personnel with operations, validating processes, and equipment that are directly related to operation, filtration, cleaning, and sterilization.
- Provides general upkeep of gowning and supplies for the clean-room in manufacturing areas.
- Represented the department in cross-functional teams, projects and BR related problem resolution.
Confidential, Pearl River, New York
Aseptic Vaccine Operator
- Aseptic gowning certified with over 1000 hours experience in class 100/grade A aseptic environment.
- Participate in cleaning validations, building/area qualifications.
- Provide operational support for related SOP's, MIR's, Batch Records, ect.
- Prepare and wrap equipment used in sterile operations such as transfers and needle assemblies.
- Actively maintained proficiency in applying aseptic process techniques and gowning certification as well as perform operations and manipulations in a clean room environment using proper aseptic technique.
- Performed SAP transactions and confirming correct components status.
- Provided production lines, warehousing and packaging areas with supplies, production components and packaging material.
- Kept accurate records of activities, worked with minimal supervision, and demonstrated leadership skills.
- Performed a wide variety of tasks and operations in GMP, aseptic and controlled environments that are required to support and execute production, which included operating washing and sterilization equipment, operating filling equipment, staging and loading components and bulks, operating inspection equipment, operating manual, automatic and semi - automatic packaging equipment and completing associated batch record and logbook documentation.
- Provided general support functions to facilitate efficient and cost effective production activities, such as maintaining areas in compliance with cGMPs
- Assure adequate supply of components, processing supplies, etc. to support production activities.
- Participated in Media fill and maintaining media fill qualification status.
- Ability to handle sterile components and equipment in aseptic environmental conditions.