Ehs And Quality Leader. Osha And Fda Experienced, Fda, Sqf, Nsf

John Stains

908-***-**** / ad69e8@r.postjobfree.com

*** ******* *****, ******* **

Certifications: Investigation of Criminal Process, Practice, and Principles. SQF Practitioner ID# 307-***-****, Cythia Weber PCQI AIB International Online Business Continuity Planning, ID#1631, SQFI Larry Hood Implementing SQF Systems Manufacturing, ID# 57ad5d20-f9b1-11e7-afae-43bc8bec4889 HACCP Certification Washington State University Extension, Richard Dougherty AED/CPR/First Aid, American Red Cross, ID#00VIE85

Skills: Auditing: Internal systems auditing and vendor compliance auditing Team Building: Developing employees to become future leaders of the company or department Investigations: Using KT principles, RCA for process failures, procedural gaps, employee performance or product failures. Root Cause Analysis: OSHA and FDA RCA SME CAPA Coordinator: CAPA training, implementation, challenge and review Regulatory Host: Host for Certification, FDA, OSHA and Local Regulatory Oversite Team Building: Assessing employees for the right roll or position for success Latent Stage Conflict Resolutions: Correcting disagreements and building bridges before conflict erupts.

Collaboration and Teamwork: Waste Water Systems: Assisted in and collaborated with the Facility, Engineering, Operation Department to successful design, build and incorporate a waste water filtration and treatment process. Waste Management and Landfill Reduction: Two separate occasions developed a sustainability plan to reduce landfill pressure by over 90% by weight. Sustainability Certification: Certification for Sustainability in the pet industry achieved through cross department collaboration and one vision for success. Internal Auditing: A proven trach record of excellence in environmental monitoring results, facility compliance and safety compliance. Campus Security and Ambassadorship: Using various CCTV, security presence and continual awareness of surroundings, safety issues dropped to no observations the last two years. Develop Train the Trainer Programs: Allowing floor leadership to be responsible and own training, allowed the culture of leadership to be cemented on the floor.

Consultant: As a consultant with a multi-industry background my experience has ranged from organic farms to large pharmaceutical facilities. I have utilized my skills in building and designing sanitation, quality units, assisting quality units to achieve internal goals, developing safety programs for companies and interfacing with certification bodies, Federal Agencies or local agencies when required.

Work History

FIG Consulting Managing Director. April 2024 to Present:

Regulatory oversite for Local, State and Federal Compliance

Implementation of regulatory systems for SQF, NSF, Organic, or religious requirements.

Oversite of vendor supplier program.

Developed a short term and a long-term strategy for certifying body compliance and regulatory compliance.

Developing and maintaining a government trending process to ensure the company is ahead of future regulatory requirements.

Ensure all projects are compliant to OSHA, FDA and local regulatory requirements.

IQ/OQ/PQ for operating equipment.

Assist in business planning and strategy for future growth and internal capabilities.

Monitor then manage the complaint analysis team.

Mentor and motivate employees to develop into future leaders for the organization

Latent Stage Conflict Resolution between veteran employees, new employees and current employees.

Investigator for all Human Resources, process, production, product or OOS.

Document developer for PMR/MMR and procedures, processes, protocols, and work instructions.

Develop proper pest control foundations and targets for the facility

Develop and build relationships with external experts through our private or professional network.

TFH Publication / Nylabone: Multiple Sight Director of EHS-S and Sanitation. August 2021 to April 2024:

3 managers and over 100 employees (leads and floor) within the department

EHS-S: Annual reduction of TRIR and incidents. Final 0.19 (from 2.7)

Developed onboard training for all new employees for HR, EHS-S, Quality and Food Safety.

Developed a monthly audit EHS-S, Sanitation, process, regulatory and food defense audit to maintain and drive all compliance requirements.

98% compliance achieved through mentoring, TBT, Verbal JHA and formal trainings for employees.

Developed compliance investigations for EHS-S and Sanitation.

Sanitation training and chemical titration awareness resulted in zero sanitation failures from Nov 2021 to April 2024.

30% reduction of employees accomplished through efficient cleaning and proper chemical use.

Sustainability Team, a theoretical reduction of landfill waste by upwards of 90% achieved by recycling food waste, plastic waste and cardboard.

1.1 million dollars in waste savings and a buy back program of over $300,000 annually.

Pest remediation within all facilities and operating areas.

Nylabone: Interim QC Director February 2022 to August 2023

2 managers and 32 technicians

PCQI/SQF Practitioner

Increase team to have all phases of operations covered with QC Technicians

Developed an organoleptic program for incoming RM and finished product

Developed incoming RM review to be compared to set standards and internal specifications

Host for Organic, SMETA, SQF and FDA audits.

Upgraded in process tests to an industrial high-speed analyzing equipment.

Regal Commodities: Director or Processes/Quality October 2017 to August 2021

2 supervisors and 12 technicians

Oversaw the day-to-day Quality and process operations, sensory lab, RD design and equipment upkeep.

PCQI/ SQF Practitioner.

Lead investigator for Laboratory OOS, food safety issues, complaints, micro contamination or product failure complaints.

Developed a recycling and a waste to energy program for product waste manufacturing.

FDA host, third party certification host, and client audit host.

International auditor for supplier and, contract manufacturers

SME for internal process, sensory lab and packaging display

Developed a release program for Quality Assurance and client satisfaction

Complete environmental monitoring program developed around seasonal differences and constant condition environments.

Redesigned pest control program to confront grocery pests and occasional invaders, reduced all pests by over 98%

Developed IQ/OQ/PQ protocols for existing equipment and newly purchased.

Specification controls established throughout the process, reducing in process OOS by over 85%

Cost saving initiatives through purchase power, waste management, facility upgrades (recycling center)

Training and onboarding of all employees for OSHA requirements, OTJ training, perpetual coaching, and holding all employees accountable for their actions.

Jones Lang LaSalle: Compliance Manager of the Americas July 2015 to October 2017

1 direct report, 7 indirect.

Lead investigator for all regulatory compliance and facility issues.

Developed a monthly audit plan that encompassed all regulatory agencies (global and local) and business contracts.

Vendor auditor for the Eastern United States for our assigned clients.

CAPA Manager and approver for all JLL activities for the New Brunswick NJ facility.

New Business acquisition team.

Developed and implemented training tools to ensure employees are UTD with training requirements.

Authored and implemented the global quality manual for all Life Science contracts.

Mentoring interns and employees to achieve future growth within the company or their careers.

Procedure and Protocol challenges performed annually by the document team.

Redesigned the pest control plan to ensure the correct pests are being targeted and reported correctly.

Multiple building campus.

Oversaw the security team of the facility to ensure employees, animals and property were monitored, addressed and in state of control 24/7.

As a consultant to BMS, Abott, Novartis and HHMI, our team assisted in and developed more efficient facility management plans, quality outcomes and decreased incidence by over 85%.

PIM Brands EHS-S/Sanitation Manager May 2013 to June 2015

Manager of Quality/Sanitation and EHS. 9 direct reports on a multi building site.

A 24/7 operation with multiple campuses and manufacturing actions being performed at each site.

Multiple site auditor and strategist for regulatory issues.

Established a critical sanitation program that eliminated failures for micro contamination.

Developed a waste water treatment process to reduce regulatory fines by over 80%.

Developed a waste management system that developed a “green” waste program and provided significant cost savings.

With a waste management company, became almost a zero-landfill use company.

Three successful SQF audits in a row

CAPA Manager and, audit findings CAPA coordinator.

Developed all sanitation Zones and a risk-based cleaning verification program

Developed a pest control system to have an overall reduction of pests by 99%

Developed a facility trend map for machine failures, quality issues, sanitation/micro issues, and waste increase trends.

Monitored companies KPI program to track progress or set backs

Budget responsibility for chemicals, equipment, EHS and environmental affairs.

Protica Quality/Facility Remediation Manager September 2012 to May 2013

11 reports on a multi building site.

Remediation manager for all CAPA, investigations, deviations and regulatory findings.

Developed a training program and an FDA awareness program to decrease GMP issues in the facility.

Worked closely with the FDA to work through an emergency permitting and answer all warning letters from past observations.

Developed a record review process that reduced GDP issues by over 83%.

Developed and initiated the audit program to increase awareness of facility and sanitation needs.

Designed a waste to energy management system to increase cost savings and environmentally friendly company.

Lead investigator for all non-conformances.

Sensory lab and organoleptic SME for all products made within the facility.

Consulted after sale of company to transfer technical expertise to other facilities.

Accupac Project Quality Assurance Manager May 2021 to September 2021

Assist with the IQ/OQ/PQ of the manufacturing equipment.

Investigate validation failures

FDA Host.

Training coordinator for all new employees.

Technology transfer from Philadelphia to Lakewood, 100% successful.

Chaired the Quality Compliance Council.

Designed and built two in process laboratories, a sensory lab for fragrances and flavored product.

Tris Pharma QA Specialist April 2011 to March 2012

Quality Management Project, writing procedures and training on protocols.

Used as a GMP/Quality specialist for their chewable product line.

Developed a tracking and tracing program for the DEA associates to use when reconciling chemicals.

Developed a metric for the quality team that incorporated the DEA requirements into the plan.

Developed a training comprehension program to ensure that all protocols and procedures were understood by the persons being trained. This was a custom design using their native language, oral tests and visual aides to make job performance more consistent.

GSN Senior QA Manager Nov 2006 to April 2011

Senior QAM of Regulatory Compliance (North America/China) responsible for 8 managers and 12 supervisors on a multi-site facility (NJ and FLA).

Regulatory and Certification Body host.

Performed efficiency and time study analysis for Senior Management.

Challenges all procedures and protocols.

Investigate all facility, operational, laboratory and product non-conformances.

CAPA coordinator and challenge for review annually to determine if the CAPA was effective.

Budget oversight for equipment purchasing, facility improvements and training needs.

Oversaw all document review and laboratory results.

Lead troubleshooting specialist for all OOS and OOTs documented in the facility.

Lead the company through annual regulatory reviews from USA, AU and Canada.

Pliva QA Senior Supervisor April 2005 to October 2006

Managed 5 supervisors and 12 leads on a 24/7 multi building site.

Maintained continuous improvement systems.

KT investigator and trained in six sigma principles.

Lead investigator for ATF, FDA, DEA and local agencies.

Maintained a budget for equipment, training and various needs within the department.

PFI Quality Assurance Manager Sept 1998 to April 2005

Managed a team of Quality Inspectors and Supervisors for a multi building 24-hour operation.

Lead investigator for OOS and OOT.

Host for all regulatory agencies.

Validate equipment and processes when required

Designed the IQ/OQ/PQ system for new equipment installs.

Developed and ran the intern development program.

Chestnut Group Quality Assurance Manager November 1994 to September 1998

Chaired the ISO 9002 Quality Team

Audited off site vendor labs for compliance and documentation follow up

Worked as the host for OSHA, FDA and DOT inspections

Reduced complaints by over 70% through trending and tracking of issues

Began the continuous improvement program for CG.

EDUCATION: Kean University (BA History)

Hobbies/Interests: Community Beach Volunteer, the Las Vegas Raiders and Animal (wild/domestic) rescue or rehabilitation.

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