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Role Description

Reports to: Director of Quality

Location: Portland, Oregon

Start Date: ASAP

The Regulatory Compliance Manager will be responsible for the establishment, maintenance, planning, directing and coordinating of programs, procedures and processes necessary for manufacturing food ingredients in accordance with local, state and national regulatory agencies. Will maintain an acceptable level of product safety and quality to meet specific customer requirements and company standards. Support and aid operations in making safe and quality products.

Role Responsibilities

• Creating and reviewing regulatory compliance documentation.
• Coordinating the creation, review and implementation of policies and procedures resulting from new laws and regulations.
• Designing and coordinating the preparation and ongoing review of policies, procedures, training materials and other communication tools to ensure departments meet compliance requirements.
• Filing regulatory reports and other documentation.
• Coordinating rollout and training of new or updated policies and directives when required.
• Develop and maintain HACCP procedures, SOP’s, SSOP’s, Food Safety Plans and other requirements for compliance with the Food Safety Modernization Act (FSMA).
• Maintain the state certification as well as permits for processing.
• Interface with all regulatory agencies’ PDA, FDA, as well as organic, koshering agencies, halal, and customers.
• Lead in regulatory, customer and third-party audits and coordinates audit responses to all findings.
• Conducts or manages internal audits on a regular basis necessary to confirm compliance to SQF and other applicable requirements to determine food safety and quality systems are being maintained and followed.
• Oversight of Customer Complaint Program and issuance of a response to the customer.
• Develop and maintain the Environmental Monitoring Program. Oversight and/or performance of indicator organism testing, preparation of composite samples and collection of environmental samples for 3^rd party pathogen analysis.
• Develop and maintain a pest control program in collaboration with a 3^rd party provider.
• Manage direct reports by setting goals and objectives and oversee execution of these goals and objectives. Manage and supervise QA laboratory activities and laboratory personnel, coordinating daily work activities and oversee instrument calibration and preventive maintenance programs as it relates to equipment used in the laboratory. Ensure compliance with written procedures.
• Develop and implement methods and procedures for disposition of aged and non-conforming materials. Review and approval of all investigations related to out-of-specification results, non-conforming material reviews, and significant batch deviations.
• Facilitate Supplier Approval Program for raw materials and direct contact packaging with responsibility for facility risk assessment and approval of each material.
• Responsible for the development, implementation and maintenance of the Food Safety System and Quality Plan.
• Oversight of completed batch record review and issuance of Certificates of Analysis.
• Reporting to management on the effectiveness of the Quality Management System.
• Champion effective Root Cause Analysis and provide oversight of the Corrective & Preventive Action Plan.
• Champion continuous improvement in all Quality processes.
• Must maintain HACCP certification status. Trained as PCQI and as SQF Practitioner.

Skills & Qualifications

• Bachelor’s Degree in Quality or Food Science or related field is preferred with a minimum of five years’ experience in a Quality Control Laboratory and three to five years’ experience in Quality Management with demonstrated leadership experience within the field.

• Demonstrated working knowledge of cGMP for Food, as well as good laboratory practices, testing methodologies and manufacturing practices as described in the Code of Federal Regulations (21CFR 117).

• Demonstrated ability to understand and organize technical data for communications and analysis

• Demonstrate excellent oral and written communication skills and possess good interpersonal skills.

• The ideal candidate possesses certifications in HACCP, FSPCA Preventive Controls and SQF; and training in environmental monitoring, auditing and statistical process control.

• Must possess good communication and possess the highest integrity in conducting business affairs. Must exercise maturity and sound judgment in all dealings and associations with vendors and customers. Must be able to work independently and to organize tasks and manage the workload. Ability to deal with problems involving several variables in standardized situations, while defending decisions in a knowledgeable and rational manner. Able to interpret customer requirements and government regulations and apply to BlendHouse products and processes.

• Infant Formula or Food manufacturing experience preferred
• This job requires the employee to be able to lift 50 lb./25 kg bags or drums during the batching and bagging process. Need ability to stand, crouch and climb to perform adjustments to equipment, use ladders, and perform various types of manual labor.