ROBERT ALLEN

• Drives continual improvement by challenging current practices and identifies improvements that enhance efficiency and eliminate waste
• Assure AMG and Joint Venture (e.g., FRVE) programs are compliant with current FDA food and drug regulations and all other state, federal, and international statutory and regulatory requirements
• Interpret and advise leadership of the applicability of U.S
• Federal, state, and international regulations and customer driven requirements
• Leads the development and implementation of the QMS to include local processes and procedures for new (construction / acquisition) plants, terminals and trans fill locations
• Leads the development and implementation of annual improvement strategies to strengthen quality and compliance programs within the assigned area
• Monitors government regulations, professional, trade publications and advises the Senior Director of new and changing food and drug regulations, customer requirements and/or industry litigation
• Represents AMG when meeting with federal and state regulatory agencies regarding food & drug registrations, licenses, permits, enforcement actions and public hearings as required
• Provides regulatory and internal QMS leadership when supporting AMG operations, distribution, and sales teams to achieve growth objectives and strategies
• Leads investigations and root cause analysis to assure effective corrective and preventive actions to customer complaints or product quality nonconformities
• Reviews the effectiveness of corrective actions and intervenes when secondary resolutions are required
• Leads field staff and provides advisory support for FDA government inspections, customer and certification audits
• Directs the drafting of audit responses to certification and customer audits
• Works with Airgas SAFECOR when responding to audit findings resulting from FDA inspections
• Negotiate satisfactory resolutions to customer concerns related to product quality
• Develop and lead annual internal compliance audit plans in accordance with cGMP and AMG requirements
• Leads in the creation and approval of AMG policies and procedures ensuring compliance with regulatory requirements
• Leads assigned projects and assures manufacturing and product delivery processes used for the manufacture, storage and delivery of drug products are properly validated in accordance with FDA and CGA requirements
• Leads assigned projects assuring that manufacturing and product delivery processes used for the manufacture, storage and delivery of food products are properly assessed per FSSC 22000 requirements and PRP/OPRP are properly identified and managed
• Assumes a leadership role ensuring the effective leadership of assigned field Local Quality Control Units
• Monitor programs and identify compliance gaps and lead actions to close gaps prior to regulatory action
• Reviews corrective actions and leads efforts to “fan out” resolutions to all affected sites to prevent repeat events
• Develop Quality & Compliance metrics to drive improvement at assigned sites and provide regular updates to AMG leadership
• Leads Quality and Compliance field awareness through the sharing of performance metrics and relevant audit data
• Lead quality and compliance training programs to ensure that AMG personnel maintain good working knowledge of regulatory requirements
• Utilizes cost benefit analysis and risk-based methodologies when drafting quality and compliance program improvements to confirm value prior to commitment
• Solicits input from stakeholders to gauge impact of change prior to implementing program revisions
• Leads continual improvement within the group and partners with internal organizations when implementing business improvements
• Lead site qualification for ABO and other products used for military applications
• Provides QMS leadership by verifying that field staff is adequately trained to perform all required duties and to remain current on new regulations and quality trends
• Supports IMS Implementation, as needed, in areas of procedure revision, auditing, and gap closure plan creation
• Maintain costs associated with quality and compliance in accordance with established group budgetary constraints and when necessary, leads corrections needed to reestablish control
• Select and manage external consultants and registration bodies assisting with external certification
• Participate in industry trade organization task forces directly relating to validation, such as the CGA and ISBT as assigned
• Provides leadership for third party (Coke, Pepsi, Tyson Foods etc.) audits, qualifications to ensure completion per customer expectations
• Leads efforts to attain facility FSSC 2000, ISO 9001, NSF 60, Kosher, Halal, and Non-GMO certifications
• Lead Auditor for internal audit program
• Leads food safety HACCP, HARPC and quality risk assessments.

• Restructured Facility QMS which laid the ground work to achieve ISO 9001 and GFSI certifications
• Increased batching and filling efficiency by 12.7% through DOEs and capability studies and developed site level KPIs to track performance
• Reduced the cost of Non-conformance by 8% by utilizing lean manufacturing tools
• Created an MOC process that reduced downtime due to product and packaging changeovers by 35%
• Provided day-to-day hands-on technical support to Operations, Logistics, and Warehousing which included problem solving and troubleshooting as needed
• Restructured the Facility Master Sanitation Program which increased our third party GMP audit score from 87 to 98.4
• Facilitated the creation of an on-site laboratory reducing Environment Monitoring cost by 21%
• Fortified the overall Environment Monitoring Program driving down micro counts in previously labeled hot zones to consistently BDL results.

• Accountable for the completeness and effectiveness of a policy framework for the management of the USIG Quality Program and monitoring compliance key performance indicators
• Implemented and maintained a program that meets requirements for Good Manufacturing Practices (GMP) for medical gas products, FSSC 22000 Food Safety management system for food applications, ISO 9001 Quality management system, and cGLP (17025) for all products
• Improved and maintained the Quality Management Program to assure compliance with regulatory requirements for the FDA, Health Canada, EU, and JP
• Supported regional business units in meeting their customer supply objectives while ensuring that quality programs are established and followed to meet regulatory requirements
• Oversaw and drove improvements to the audit process to ensure compliance to Customer requirements, ISO 9001, FSSC 22000, FDA, and Health Canada
• Manage Quality Assurance team’s workload to ensure adequate oversight of the quality management system
• Reviewed all quality incident reports for effectiveness of corrective actions and approved for closure
• Managed document control development and medical validations related to the quality system, including review of medical site-specific operating procedures for new facilities
• Fill Zone/Advanced Control Systems: Accountable for process control and monitoring systems for automated Fill Zones in CO2 plants and Air Separation facilities which included bulk liquid, bulk gas, and pipelines
• (Argon, nitrogen, oxygen, CO2, helium and hydrogen) Made technical decisions based on full awareness of viability, cost, and other benefits and worked those solutions through the project team for approval and final implementation
• Work closely with plant operations to deliver solutions to improve efficiency and operability for fill zones throughout North America, Puerto Rico, and the Dominican Republic
• Project Manager for several productivity and automation projects.

• Plans, directs and coordinates Quality Assurance activities within the company
• Facilitates identification of site-level KPIs
• Manages the Food Safety and Food Quality Programs including Quality and Food Safety training
• Leads on-going maintenance and improvement of plant’s quality and food safety systems
• Monitors and maintains micro testing and tracking programs
• Manages day-to-day activities of all Quality personnel within Plant Operations
• Handles traceability and performs mock trace through AX
• Monitors and maintains: Audit Programs (Facility and 3rd Party), Customer Complaint investigation, SQF documentation and verification & validation, Regulatory Compliance (USDA/FDA) activities
• Leads preparation of responses and site-level follow up activities for all outside audits (Regulatory, Customer, Corporate, etc.) conducted within plant
• Identifies quality systems training needs for plant personnel and leads, facilitates/enables development and delivers/sources relevant training
• Manages facility Sanitation Program
• Handles Tech Supervision to include scheduling, training and accountability
• Provides Daily Documentation Review and Hold Log Management
• Manages and oversees Product Development through: Specification writing, Nutritional Analysis, Vendor communication/sourcing, Sample assembly, Formula creation, Manage new product items into AX, Manage formulas in AX
• Oversees customer and sales’ sample preparation, shipment, specifications and plant trials
• Heads efforts in Process Control of process improvements, KPI tracking and trending, waste monitoring and reduction and lead associated activities toward resolution
• Provides day-to-day, hands-on technical support to Operations, Procurement and Warehousing functions which included problem-solving and trouble-shooting activities as they arise, phytosanitary certificate request for foreign export, and supplier approval programs.

HERSHEY’S FOODS, Food Producer (11-month contract)

Sr. QA Specialist,

• HACCP & PEP Review

• Process flow validation

• SCP, QCP, MCP Review and validation

• Root Cause Analysis on non-conforming products and out of control processes identified through area KPIs

• cGMP compliance and internal auditing support

• Extraneous Microscopic and ATP swab testing and validation

• SQF compliance support and auditing

• Investigated and responded to all consumer complaints for West Hershey Facility

• Process validation for GMO and non-GMO production

GLAXOSMITHKLINE BIOLOGICAL, Pharmaceuticals (7-month contract)

QA OPS Specialist,

• Issued and performed final review of Batch Records for single dose vaccine production.

• Collected retain samples and performed AQL checks.

• Performed zone clearance validations for syringe and vial packaging lines.

• Performed room clearance validation for Manual Visual Inspection areas.

• Linked Change Controls, Process Events, and Deviations to Batch Records using SAP.

• Performed cGMP and GDP compliance support

HANOVER PACKAGING, Packaging Co Packer (5-month contract)

Quality Specialist,

• Document control and first article samples approval.

• Initiated and investigated all NCMR. Process auditing.

QPSI PACKAGING INTERNATIONAL, Consumer Goods Co Packer (7 months contract)

Quality Specialist,

• Review and approve specification booklets and batch records prior to being issued for production.

• Review and approve post production batch records.

• Handled all SCAR, CAPA, and NCMR investigations.

• Monitor production floor to ensure compliance with GMP and customer specifications.

•Approve all first article samples and inspect finish goods and work-in-progress items.

• Write Redress/Rework protocols.

C&S WHOLESALE GROCERS, Grocery Distributer (7-month contract))

Safety Supervisor,

Along with 4-member safety team insured employee compliance with all company safety rules. Coached employees on how to performing their assigned tasks using established safety techniques.