John Stains
Keyport
Summary
Dynamic leader with a proven track record at FIG, excelling in operational leadership and regulatory compliance. Achieved zero incidents through a robust safety culture while mentoring teams to enhance performance. Expert in waste management strategies, driving significant cost savings and sustainability initiatives. Committed to fostering collaboration and continuous improvement across all levels.
Overview
27
27
years of professional experience
14
14
Certifications
Work History
Head of QAEHS-S/Operations
FIG
04.2024 - Current
- Championed the training and education of employees, through traditional means, mentoring and clear expectations of development.
- Regulatory oversite for Local, State and Federal Compliance. Including OSHA, FDA, DEA, DOD and local regulatory groups.
- Leads the CapEx team for equipment or facility expansions.
- Increased capacity of warehouse through vertical expansion, and 98% efficiency from production lines.
- 99% OTDIF.
- Partnered with Supply Chain to manage a recurring $4 million dollar inventory.
- Operating budget of approximately $12 million.
- TRIR reduced from 3.0 to Zero.
- Zero incidents and accidents from June 2024.
- Developed OSHA and Quality Manuals for facility and operational employees. Developed a safety and quality culture with a floor up philosophy.
- Ensure all projects are compliant to DOH, OSHA, FDA and local regulatory requirements.
- Designed and implemented the OSHA, Facility, MSS and Regulatory audit system.
- Lead investigator for all non-conformances OSHA, FDA, and state requirements (human, process, equipment, procedures).
- Assist in developing and implementing future OSHA requirements.
- Oversees the campus action requirements FIG. From inception to shipping.
- Reinforcing and driving the strategic mission, vision and objectives of FIGs Mission Statement.
- Regulatory Host.
- Oversees the tradesmen and utility output.
- Designed and implemented the campus MSS and sight sanitation programs.
- Sustainability champion for the campus.
- Developed a short term and a long-term vision for the site and developed a strategic plan to incorporate all business / corporate objectives.
- Ensure vendors are partnered and trained on the internal core mission of safety, excellence, quality compliance and complete expectations of what is expected from each vendor.
- Process Improvement champion for efficiency actions, reducing time waste and increasing profit.
- Mandatory weekly team meetings with leadership in cross functional departments.
- Ensure operations is focused on safety, cost control, and long-term partnerships with our transport teams.
- Risk assessment audits conducted monthly to ensure hazardous material exposure, fires, slips and falls or ladder safety is nonexistent or corrected immediately.
- Assist in developing and implementing future OSHA requirements.
- Align sales with procurement, scheduling, production and shipping for each order, to ensure internal and external customers are taken care of.
- RCA for non-conformances within the safety system.
- Mentor and motivate employees to develop into future safety leaders for the organization, through training, mentoring and easily applied systems.
- Lead investigator for all non-conformances OSHA, FDA, and state requirements (human, process, equipment, procedures).
- Continual Improvement champion for process, people, contracts and facility related activities.
- A non-traditional floor manager that engages with employees to develop a company culture based off of recognizing proper behaviors.
- Main contact and auditor for all vendors, including contract manufacturers.
- PL Accountability.
- Manufacturing costs per unit.
- Inventory value control.
- Full operational oversight of Gummy lines and special projects.
- Negotiate contracts and KPIs for vendors, internal departments, contracted employees and contractors to reduce cost and promote a safe work culture.
Director of QMS/EHS-S Facilities
TFH Publication
08.2021 - 04.2024
- 3 managers and over 100 employees (leads and floor) within the departments.
- Oversaw the facility and safety programs for multiple NJ/VA facilities and international sites.
- EHS-S: Annual reduction of TRIR and incidents at all facilities. 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% OSHA compliance achieved through mentoring, TBT, Verbal JHA and formal trainings for employees.
- HAZ Mat awareness trainings.
- Oversaw all housekeeping, landscaping design and front office hospitality.
- 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. Automation, predictive maintenance and sustainability program.
- Sustainability Manager, 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 buyback program of over $300,000 annually.
- Pest remediation within all facilities and operating areas.
- Zero third party observations for three straight years in sanitation.
- Negotiated temporary labor costs, increasing the number of agencies from one to three for a better representation of labor costs.
- Negotiated equipment purchase, install and IQ/OQ/PQ.
- Assisted sales in client, company, walk throughs and questions.
- Monthly presentations on Waste reduction, environmental monitoring, client complaints and SQF non-compliances.
- EHS and Sanitation had 100% accuracy for government and compliance audits.
- Oversaw the automation roadmap for extrusion to operations, in line testing and results, packaging, palletizing and wrapping, removing human input from approximately 20% of operations.
- Dog/Cat vitamin program.
- KPI: OTDIF, Yield improvement, capacity use, OE, FTR, TRIR, Batch Record reviews, Waste.
- With Supply Chain, managed a $60million dollar rotating inventory.
- Overall cost reduction average of 6% annually, predictive maintenance, waste, automation.
Director of QMS/EHS-S
Regal Commodities
10.2017 - 08.2021
- 2 supervisors and 12 technicians.
- Head of the SAP implementation.
- Installed data boards throughout the facility to visually see each equipment performance.
- 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).
- Negotiated the cost of packaging, blending and fill equipment.
- Oversaw the dietary supplement division, powder blends, KCup filling and various packaging configurations.
- Training and onboarding of all employees for OSHA requirements, OTJ training, perpetual coaching, and holding all employees accountable for their actions.
Compliance Manager of the Americas
Jones Lang LaSalle
07.2015 - 10.2017
- 1 direct report, 7 indirect.
- Lead investigator for all regulatory compliance and facility issues.
- Implemented a monthly audit plan that encompassed all regulatory agencies (global and local), business contracts, Health and Safety, Security and internal scope of work.
- Reviewed the efficiency, safety and satisfaction of the restaurants within the facilities. Chicago, New Brunswick, Princeton, and the Summit locations. 7 traditional establishments, 15 cafeteria and grab and go locations.
- New Account Acquisition Team Member: Would travel to one of the three main JLL sights to meet new clients. Heavy involvement with pricing and bids.
- 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.
- Oversaw all janitorial, housekeeping and front greeting areas.
- 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.
- Assisted in union contract negotiations.
- 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.
- Presented to clients the health of the contract, areas that improved and areas that will be improving.
- 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%.
- Head of the TrackWise initiative for the account.
- Head of margin improvements through vendor partnerships, outsourced work (landscaping/sanitation) and predictive maintenance programs.
Manager QMS/EHS-S
PIM Brands
05.2013 - 06.2015
- Manager of Operational 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.
- Small generator of hazardous materials.
- HAZ Mat training coordinator.
- 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 and sustainability 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.
- Scheduling coordinator for allergen, maintenance and emergency equipment breaks.
- Gummy R/D team for flavor, sensory, nutraceutical compliance and run efficiencies.
Manager QAEHS-S, Facilities
Protica
09.2012 - 05.2013
- 11 reports on a multi building site.
- Head of operations and supply chain.
- 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.
- Head of efficiency and line output, oversaw manufacturing and OTDIF program.
- Presented CapEx and expansion plans to CEO.
- Interfaced with finance department monthly to align with company goals and requirements.
- 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.
- Scheduling coordinator to work with sales, maintenance, sanitation and R/D to ensure equipment was set and ready for operational needs.
- Head of margin improvement by diversifying vendors and purchasing from overseas and through brokers.
- Gummy, shot, mixes, powder oversight of operational management. Small batch manager regarding, scheduling, quality, lab testing and purchasing of ingredients.
- Consulted after sale of company to transfer technical expertise to other facilities.
Manager QA Compliance
Accupac
05.2012 - 09.2012
- 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.
- ISO 13485, ISO9001 and GxP facility manager.
- Worked with FM to ensure contract compliance.
QA Compliance Specialist
Tris Pharma
04.2011 - 03.2012
- 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.
Senior Manager QMS/QA
GSN / Vitaquest
11.2006 - 04.2011
- Senior QAM of Regulatory Compliance (North America/China) responsible for 8 managers and 12 supervisors on a multi-site facility (NJ and FLA).
- Partnered with Supply Chain to oversee a revolving $20 million dollar inventory.
- Cost reductions of 3% annually through, waste management, automation and efficient line set up.
- Presented annual operating budgets for RD, Supply Chain, Quality, Security, EHS, Special Operations Projects.
- Regulatory and Certification Body host.
- Budget ownership for Quality and shared operational areas (R/D, processing, scales, transport).
- Performed efficiency and time study analysis for Senior Management.
- Challenges all procedures and protocols.
- Oversaw the powder blending, compression, encapsulation operations from purchase through finished shipping.
- COMAN auditor for gummy, soft gel, and shots not produced within the Vitaquest companies.
- 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.
- Annual operating budget of $11 million.
- SAP implementation.
- Head of margin improvement for excipient and sensory programs.
- KPI: OTDIF, Yield improvement, capacity use, OE, FTR.
- 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.
- Oversaw encapsulation and powder fill lines.
SR Supervisor QMS/QA
Pliva
04.2005 - 10.2006
- 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.
- Aligned operations to business growth plan.
- Automated warehouses were feasible and safe, automated pallet builds and wrapping in packaging.
- CapEx for security cameras and robotic security guards in the “mega” warehouses.
SR Manager QMS/QA Operations
PFI
09.1998 - 04.2005
Education
BA - History
Kean University
Skills
- Co-man auditor
- Operational leadership
- Production planning
- Safety champion
- Purchasing management
- Team building
- Mentoring and training
- Sensory evaluation
- Auditing and investigations
- Root cause analysis
- Regulatory compliance
- Document control and review
- Collaboration and teamwork
- Business planning and goal setting
- KPI tracking and reporting
- Leadership development
- Waste management strategies
- Sustainability certification
Certification
- ISO 22000.2018: 1461-36438384
- ISO 13485.2016: 1619-36438384
- ISO 45001.2018: 7725-36438384
- ISO 14001.2015: 7501-36438384
- ILO and Maritime Law: 3193-36438384
- Business Continuity: 1631
- SQFP: 307615-4097
- HACCP
- PCQI
- Health and Safety Compliance: 4885-36438384
- Infection Prevention and Controls 5396-36438384
- Investigator Crime Scenes and OSHA incidents: 1968-37911423
- Operational Management: 1272-36438384
- Holistic Nutritionist: 7542-36438384
Personal Information
Hobbies: Community Beach Volunteer, Las Vegas Raiders, Animal rescue or rehabilitation
Timeline
Head of QAEHS-S/Operations
FIG
04.2024 - Current
Director of QMS/EHS-S Facilities
TFH Publication
08.2021 - 04.2024
Director of QMS/EHS-S
Regal Commodities
10.2017 - 08.2021
Compliance Manager of the Americas
Jones Lang LaSalle
07.2015 - 10.2017
Manager QMS/EHS-S
PIM Brands
05.2013 - 06.2015
Manager QAEHS-S, Facilities
Protica
09.2012 - 05.2013
Manager QA Compliance
Accupac
05.2012 - 09.2012
QA Compliance Specialist
Tris Pharma
04.2011 - 03.2012
Senior Manager QMS/QA
GSN / Vitaquest
11.2006 - 04.2011
SR Supervisor QMS/QA
Pliva
04.2005 - 10.2006
SR Manager QMS/QA Operations
PFI
09.1998 - 04.2005
BA - History
Kean University