Summary of qualifications

Dynamic Plant Management, Food Safety and Operations professional with 20 years’ experience and a verifiable track record of successful plant startups, increasing revenues and operational efficiencies through highly effective management and leadership skills.

Effective communicator with excellent interpersonal and organization skills

Able to manage multiple tasks, set appropriate priorities and meet deadlines; adaptive to changing business environments.

Motivated and confident self-starter who leans quickly.

Innovative, influential, adaptable, effective problem solver; work well in teams and individually.

Areas of specialization include:

Plant Management and Operations – Industry specific audits, Supplier audits, Food Safety, SQF, FSMA, Quality Assurance, Maintenance, Sanitation, Supply Chain Management, Start Up Operations, Budget Oversight, P&L Management

Functional Skills:

Equipment Validation ( IQ/OQ/PQ), ISO 13485- 2016 & FDA Regulations 21CFR 820,, QMS based centered on Risk Analysis, Food Safety, FSMA, SQF Code, SQF Practitioner, OSHA-Product Release –GAP Analyst,Cost Reduction Analysis – Line / Operational Efficiency Improvement- Logistics – Raw Material Sourcing – PLC & Automated Equipment – Vendor / Supplier Relations – Internal / External Quality Audits – Manage Operations and multiple complex projects – Manage Plan budget and capital expenditures – cGMP; GLP; QMS; HACCP; CIP; SSOP's, CAPA – Lean Manufacturing – Continuous Improvement – Team Building – Safety and OSHA Training – ERP’s / MRP’s – Maintenance Management Systems – EPA and MWRA (Massachusetts Water Resource Authority) reporting – Microsoft Office (Word, Excel, PowerPoint, Access) proficiency

Professional Experience

THERMO FISHER SCIENTIFIC

Quality Control Analyst

Somerville, MA

4/2022-8/2022 Contract Position

Responsibilities

Collaborate on a high performing Quality Control specifications team within the Somerville quality organization.

Execute and manage change controls associated with the Reduced Testing Program

Drive technical documents including material specifications, standard operating procedures (SOPs), raw material testing risk assessments, and work instructions.

Drive the creation of raw material qualification reports as required.

Validate new equipment as required

Identify and implement continuous improvements for specifications, SOPs, work instructions/OJTs and material qualification processes to assure that they are efficient and effective.

Knowledge of cGxP guidelines and major pharmacopeia requirements on data analysis and review

Strong ability to develop and fit in with the QC team ensuring a competent work force that can effectively accomplish targeted objectives (Reduced Testing Program)

VIANT MEDICAL

Passivation & Finishing Dept Supervisor

Brimfield, MA

2/2019- 3/2020

Medical Device Working Data

In depth knowledge of ISO 13485- 2016

QMS risk-based analysis.

Required expectations of FDA Regulations 21CFR 820.

Passivation & Finishing Dept Supervisor

Responsibilities:

Prepare and Process all Medical Devices through Passivation Dept

Assure correct chemical/time process is used for required parts.

Package & prepare for further processing or shipment directly to customer.

Finishing Dept

Assure medical parts are prepared according to specifications for further processing or direct shipment to customer

Americraft Carton, Inc.

Lowell, MA

Quality Assurance & SQF Manager

November 2017- August 2018

Assure consistent quality of production by developing and enforcing good manufacturing practice systems; validate processes; provide documentation; manage staff and work with certifying agencies.

Primary Responsibilities

Maintain and improve product quality by completing product, company, system, compliance, and surveillance audits

Collaborate with other members of management to develop better manufacturing and training methods

Prepare quality documentation and reports by collecting, analyzing and summarizing information and trends including failed products and processes, corrective actions and quality trends – maintain Quality Standards Manual

Oversee and monitor ISO 9001:2015 Certification.

Audit ISO and SQF Systems

Perform Monthly and as needed Safety inspections.

Lead the Safety and Food Contact Packaging Manufacturing Team

Assist with personnel in writing procedures/documents.

Investigate and respond to customer product concerns - create and follow up on all nonconformance (NCR) reports.

Maintain direct relationships with key customers’ quality and plant personnel.

Abide by quality standard guidelines, work to improve the processes.

Superior Bakery

Northgrosvenordale, CT

Quality, Food Safety, Sanitation, Purchasing & EHS Manager

November 2014- September 2017

Develop and oversee all food safety regulations, policies, and procedures, develop, implement and enforce food safety standards, policies, and programs including HACCP, SQF and GMP’s, FDA Regulations, Food Defense, Sanitation, food safety training programs, standard operating procedures (SOP’s), product inspections, and standardized work instructions. Purchase all raw ingredients, PPE’s, Sanitation chemicals and equipment, production tools and work with vendors to assure all product specifications adhere to company requirements.

Led the plant in SQF Certification Level II

Improved the SQF Audit score from an 82 to a 94 in 6 months

Successfully developed and wrote the Organic Certification Process

Validate new/used equipment

Received Organic Certification in July 2016

Successfully took on the role of the plant Purchasing Agent 2 weeks after hire.

Successfully passed SQF (3 audits), FDA and State of CT Audits within 6 months of hire

Train Plant personnel on OSHA Requirements through regularly scheduled training sessions

Responsibilities & Duties:

Specific Responsibilities include, but not limited to the following:

Develop and provide training for food safety and quality requirements.

Create, or update as necessary all internal policies and procedures to satisfy SQF, FDA, FSMA and Organic requirements

Develop and maintain documentation such as SOP’s, as well as maintenance of manuals, policies and procedures as relate to any food safety concerns and outside Audits.

Conduct facility food safety audits as well as manage third party audits.

Monitor and verify activities to ensure that all products coming in and out of the facility meet food safety standards in addition to quality standards.

Update existing food safety procedures and documentation to keep up with changing requirements.

Work closely with the Production Manager, Plant Manager and Maintenance Manager concerning food safety or quality assurance issues.

Oversee proper maintenance and sanitation of the facility to comply with food safety requirements.

Ensure that all company food safety and quality assurance procedures are followed and documented correctly continuously.

Del Monte Fresh Canton, MA

Operations Manager- September 2012- September- 2014

Responsible for all plant operations through a team of Managers and Supervisors

Direct reports-Production Manager, Maintenance Manager, Warehouse Manager, Office Manager, Procurement Manager, Quality Manager, Logistics Manager, 4 shift supervisors and 4 shift foremen

Indirect reports- District Sales Managers and 200+ hourly employees

Report to the general manager on a regular basis

Target and achieve short- and long-term operating objectives in safety and quality performance, cost reductions and improved efficiencies (using lean manufacturing and six sigma principles) while maintaining the highest quality product delivered fresh to high profile clients.

Responsible for plant budgets to fall within or better than plan.

Maintain a positive attitude and corporate culture through continued positive re-enforcement while maintaining a strict regimen of coaching, training, hiring, conflict resolution and corrective actions.

Assume all responsibilities in the absence of the general manager.

Weetabix – North America

Quality Assurance & Sanitation Manager (March 2008 – August 2012)

Responsibilities & Duties:

Specific Responsibilities include, but not limited to the following:

Develop and provide training for food safety and quality requirements.

Create, or update as necessary all internal policies and procedures to satisfy SQF and Organic requirements

Develop and maintain documentation such as SOP’s, as well as maintenance of manuals, policies and procedures as relate to any food safety concerns and outside Audits.

Conduct facility food safety audits as well as manage third party audits.

Monitor and verify activities to ensure that all products coming in and out of the facility meet food safety standards in addition to quality standards.

Update existing food safety procedures and documentation to keep up with changing requirements.

Work closely with the Production Manager, Plant Manager and Maintenance Manager concerning food safety or quality assurance issues

Oversee proper maintenance and sanitation of the facility to comply with food safety requirements.

Ensure that all company food safety and quality assurance procedures are followed and documented correctly continuously

Dunkin Brands

Manufacturing Operations Manager, Canton, MA (May 2005 – January 2008)

Directly responsible for 35 Central Manufacturing Locations (CML’s) throughout the Northeast with combined sales of over $150 million.

Successfully led the opening of 10 new CML plants ranging in size from 20,000 to50,000 sq/ft; and 50 – 120 employees.

Designed and implemented training and development programs for all plant managers. OSHA safety training for all employees.

Validate new/used equipment for building construction & operations

Managed P&Ls and provided all relevant financial reports including cost analyses.

Ensured full compliance with Dunkin Brand standards and meeting or exceeding all manufacturing business related performance objectives based on cost, quality and service. Ensured retail growth is aligned with manufacturing capacity.

Responsible for spot Quality Inspections at all Dunkin manufacturing plants on the east coast (60 plants).

Led the manufacturing team expanding Dunkin Donuts in an Alpha test market – Nashville, TN.

Located and designed manufacturing plant to support new Dunkin Donuts retails stores

Each store opening set weekly sales records (5 stores)

The manufacturing team was flexible enough to keep the stores well stocked despite the challenge of record setting sales

Effectively executed proper planning, personnel training, truck routes and quality in support of new store openings

Nestle Waters North America

Quality Control Manager – Poland Spring, Framingham, MA (Aug 2001 – Oct 2004)

Managed a 4-person Quality Team for a premier bottling company. Performed daily sanitation of the plant including all manual cleaning of equipment and CIP cleaning of the filling lines. Managed departmental operating budget including capital expenditures.

Utilized creativity and hands-on methodology to reduce chemical usage for the CIP process and daily operations by 30% resulting in a savings of $150,000 annually.

Reduced computer operated CIP process time by up to 60%.

Responsible for full compliance of OSHA regulations and cGMP (Good Manufacturing Practices) and GLP (Good Laboratory Practices).

Supervised all product release authorizations including all documentation for the Quality Assurance Department involving SOP’s, corrective actions and GMP requirements.

Education

Bachelor of Science, Natural Science, Worcester State University, Worcester, MA

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