Quality Assurance Project Management

Constantin Bodiu

Manager, Pharma and Food Science

**********.******@*****.*** • 347-***-****

https://www.linkedin.com/in/constantin-bodiu-a29018b3/• Brooklyn, NY 11209

Diligent, quality-focused leader with expertise in agile project management, cross-functional collaboration, and regulatory compliance. Demonstrated ability to define and implement stringent standards and controls to comply with FDA, USP, SQF,HACCP,GMP, GDP, 21 CFR part111 etc. Excels in aligning scientific development with business priorities. Over 13 years of progressive experience in highly regulated environments, with proven risk management and vendor management experience, CAPA, CAR and Change controls skilled. Experienced with planning and conducting Audits. Personable and engaging with the communication skills needed to build consensus on critical initiatives.

Career Experience

Metropolitan Transit Authority, Hybrid

Quality Assurance Manager

December 2023 – Present

Develop and monitor Quality Assessment Programs to provide appropriate coverage of program/project assessment candidates to ensure ongoing and timely review of contractor and consultant compliance with quality requirements.

Participate in design reviews and review/development of quality specifications.

Initiate and lead Quality Kick-off meetings with contractor and consultant personnel upon contract award.

Develop quality documentation templates (QWPs, ITPs, NCRs, etc.) to provide contractor and consultant quality systems samples.

Assurance of timely and complete review of contractor and consultant quality submittals (i.e., Quality Plans/ Programs, Quality Work Plans, Inspection & Test Plans).

Conduct field visits to provide oversight and feedback on contractor activities from a quality perspective. Resolution of project quality issues.

Coordination of Special Inspection services in support of business units.

Support/input to Business Units for evaluation of Contractors and Consultants.

Lead team activities, including review of work schedules, activity worksheets, and reports.

Work with C&D Corporate Quality personnel to identify and initiate improvements in C&D processes, requirements, and activities to ensure the successful execution of the MTA C&D Capital Program. Nestle Health Science, Remote August 2021 – July 2023 Supervisor Global Quality Specifications

Developed and implemented quality standards aligned with ISO-9001, cGMP, GDP and HACCP best practices.

Collaborated cross- functionally with multidisciplinary specialists to evaluate and optimize new products and raw materials.

Coached and mentored junior team members to cultivate a quality-oriented culture.

Ensured appropriate control, update, and communication processes were in place to align operations.

Provided technical assistance to internal departments and manufacturing sites to ensure clarity around specifications.

Collaborated closely with the Product Development and Regulatory teams on multiple innovation and reform projects, providing technical support to suppliers in areas such as formulations, stability studies, nutrient content claims, and testing specifications.

Arranged meetings for conducting investigations regarding out-of- specification cases starting from the reporting of the OOS until the resolution of the respective case.

Participated in Change Control and Deviation meetings by conducting statistical analysis of laboratory test results using Minitab.

Performed risk assessments of heavy metals based on their usage and supplier's CoA’s.

Created Change Control Reports (CCR) through the Oracle system (PLM).

Ensured the generation, update, and communication of specifications to all necessary parties through different workflows in the Oracle PLM system.

Took part in cross-functional teams responsible for evaluating new raw materials daily, particularly as they related to the development of new, reformed or innovative products. Key Accomplishments:

Spearheaded creation of new specifications process through proactive engagement with global regulatory teams

Oversaw a team of six Specification Specialists, managing daily tasks and supporting their professional and personal growth through weekly 1:1, mid- and end-of-year reviews

Diligently collaborated with multiple teams to uphold quality Key Performance Indicators (KPI’s) at 98%

Led the TiO2 free project that aimed to eliminate TiO2 from company products, which was crucial for maintaining company presence in the EU markets

Contributed to and played an active role in multiple global product development projects within the vitamin, dietary supplement, and pet dietary supplement categories

Successfully launched various products globally with budgets exceeding $8 million Krinos Foods LLC, Bronx, NY

Supplier Management and Quality Assurance Supervisor December 2017 – August 2021

Ensured the quality and compliance of all products through monitoring, verification, and validation

Identified and evaluated potential new suppliers based on quality, cost and reliability

Assessed supplier performance through KPI’s and regular reviews, to ensure compliance with contract

Conducted the risk assessment for new suppliers and raw materials

Identified potential risks in the supply chain and developed mitigation strategies

Produced accurate and comprehensive documentation for all activities

Identified safety and quality issues and implemented corrective actions to resolve non-conformances

Conducted internal audits against corporate, customer, and government standards

Compiled repeat findings to enable trending and drive continual improvement

Owned the full life-cycle management of company products in WMS HighJump Key Accomplishments:

Built and maintained foreign supplier verification program (FSVP) and supplier chain management in Food SafetyPlus.

Wrote Standard Operating Procedures (SOP’s) for plant sanitation program in alignment with food safety Standards and regulations.

Prepared the plant for SQF certification by implementing various measures and maintaining a high level of compliance. Maintained the certification at 98% score. Tribeca Oven, Carlstadt, NJ April 2016 – December 2017 Quality Assurance Technician

Drove continuous improvements for product quality through auditing, complaint resolution, new designs and updated training methodologies.

Led training on risk mitigation, GMP and company policies.

Partnered with quality manager and quality director to develop quality programs including inspections, documentation, root cause analysis, and corrective action. Key Accomplishments:

Deployed and optimized TraceGains for Tribeca Oven plant, and trained employees on usage.

Built and maintained Trace Gains chain of suppliers and led automatic COA check in project.

Assisted in launching and ensuring functionality of two new product lines 6000 and 9000 lb./h.

Worked with Product Development and launched new products like Olive Ciabatta, Multigrain French Rolls and Cheese Bread.

Worked with third party contractors on the development and testing of new packaging material for Panera sourdough bowls.

Supported the introduction of WinSPC Quality Management System for the entire facility, which helped reduce scrap and rework costs along with a reduction of process variation and material consumption by 19%.

Whole Foods Market, Brooklyn, NY March 2015 – April 2016 Quality Assurance & Warehouse Specialist

Received and inspected all materials and products entering the store.

Inspected, tested, and sampled materials and products for defects and deviations.

Monitored all store CCP.

Coached and mentored employees as Team Lead for inventory and team building operations.

Validated all certificates of analysis for incoming materials and packaging.

Responsible for designing in-store signage and product layouts on shelves to maximize sales.

Orchestrated mid-year inventory.

Technical University of Moldova, Chisinau, Moldova September 2011 –September2014 Engineer – Laboratory Supervisor

Led multidisciplinary teams in the execution of biotechnological and mechanical research projects.

Maintained teaching laboratories, repaired equipment, and supported faculty research efforts.

Oversaw LabVIEW virtual instrumentation programs.

Assisted in planning and development of laboratory for thermal and vibration influence research.

Collaborated with the Academy of Science of Moldova on projects for third-party clients. Harvit-Pro SRL, Republic of Moldova February 2010 - September 2011 Quality Manager

Develop, implement, review, manage, and ensure compliance to HACCP, SOPs, SSOPs, GMPs, Organic, Kosher, Pest Control, Sanitation, Lab testing, and Recall procedures.

Conduct the risk assessment for new suppliers and raw materials.

Support Change Control and periodic review of the controlled documents

Interview and hire new associates as well as training current staff on GMP and Food Defense

Manage Finished Product Nutritional label and nutrition, along with claims, working closely with product development, R&D and marketing team on new products. Education

Master of Science, Food Science Technical University of Moldova 4X National Champion, Civil Protection Team

Bachelor of Science, Food Technology and Management Technical University of Moldova

Licenses & Certifications

Lean Six Sigma Green Belt Certified

Certified ServSafe Manager at National Restaurant Association

Licensed in food protection at New York City Department of Health and Mental Hygiene

FSPCA Licensed Preventive Control Qualified Individual (PCQI)

Certified Food Safety Management System Auditor

HACCP Certified

Certified Internal Food System Auditor

Foreign Supplier Verification Programs Certified (FSVP) Technical Proficiencies

Tools: Genesis, PLM, AS400, SAP, Trackwise, QDocs, Lotus Notes, Citrix, LASCOM, Veeva Vault, HighJump WMS, Minitab, Win SPC, OmniPage, TraceGains, AutoCad, Excel, Microsoft Word, PowerPoint, Food Safety Plus (GFSCGroup Software) Hardware: Swabs, Thermometers, pH Meters, Moisture Analyzer, Salt Analyzer Languages

English —Professional Romanian — Native Russian — Professional

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