Quality Operations Manager

Role Description

The Quality Operations Manager will be responsible for plant compliance with the Food Safety and Quality plans along with supporting prerequisite programs.  Will manage quality operations and product release activities to help ensure compliance with all applicable state, federal regulations, and international standards for the manufacture of Food and Infant Formula products.  This role is a hands-on, highly interactive role in a fast-paced, ever-changing production environment.   The individual provides leadership within the facility to drive positive change through influence and example.  Maintains strong and understanding cross-functional relationships.

Reports To: Director of Quality

Location: ByHeart, Portland, OR

Start Date: ASAP

Role Responsibilities

• Maintain an effective plant hygiene plan and cGMP environment through cross functional teamwork with Production.
• Acts as Main Quality Liaison with Operations
• Provides support during unplanned events or emergencies
• Actively supports the internal audit program. Supports as requested regulatory inspections (e.g. FDA) and / or third-party audits / certifications (e.g. SQF, Kosher, Organic)

• Develop and implement methods and procedures for disposition of aged and non-conforming materials.

• Assists / supports in the execution of validation processes and improvement projects
• Oversees the material / product lot release process, ensuring consistent and timely release of product and ingredients in the Deacom ERP system per BlendHouse internal, customer, or regulatory requirements.
• Review Master Batch Records for completeness including but not limited to Critical Control Point (CCP) records, production records, warehouse records, sanitation records, etc.
• Coordinate with contract partners for paperwork review and product release
• Issue Certificate of Compliance or Certificate of Analysis for customers as designated by customer guidelines or internal requirements.
• Open Event Reports for findings, discrepancies, or Out of Specification results discovered during batch review process. Work cross-functionally with Quality and Production Teams to participate in and support investigation.  Ensure timely closure of Event Reports.
• Review and approval of all investigations related to out-of-specification results, non-conforming material reviews, and significant batch deviations.
• Facilitate Site Level Supplier Approval Program for raw materials and direct contact packaging with responsibility for facility risk assessment and approval of each material

• Develop and maintain the Environmental Monitoring Program. Oversight and/or performance of indicator organism testing and collection of environmental samples for 3^rd party pathogen analysis.

• Make improvements on the release process and provide necessary training regarding record keeping and procedure implementation.

• Manage direct reports by setting goals and objectives and oversee execution of these goals and objectives.

• Support Customer Complaint Investigations, driving to root cause(s) and effective resolution (corrective actions)
• Tracks and reports on plant quality key metrics and trends & prepares / issues Monthly Quality reports to management on an ongoing basis to ensure transparency.
• Participates in training for plant personnel and visitors/contractors concerning food safety, FSMA and cGMPs.
• Comply with all policies and procedures of BlendHouse and ByHeart.

• Other Duties as Assigned

Skills & Qualifications

To perform this job successfully, an individual must be able to perform each essential duty independently and satisfactorily.  It is essential that responsibilities are performed correctly and accurately. Duties must be executed in a timely manner. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Bachelor’s Degree in Biological Sciences, Food Science or related field is preferred
• Minimum of three to five years’ experience in Quality Management with demonstrated leadership experience within the field.  Infant Formula or Food manufacturing experience preferred
• Minimum of one to three years’ experience in a Quality Laboratory with Supervisory Experience preferred

• 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 106; 107 and 117).

• The ideal candidate possesses certification in FSPCA Preventive Controls; and training in environmental monitoring.
• Ability to apply commonsense understanding to carry out instructions furnished in written, oral or diagram form and must possess good interpersonal skills

• Able to work in collaboration effectively, foster good teamwork and promote a team environment and handle challenging or conflict situations with tact and professionalism

• Must possess good communication skills and the highest integrity in conducting business affairs. 
• Must be able to work independently, multi-task and keep organized records
• Accuracy and thoroughness in completion of duties is crucial to success

• Able to present options and ideas to current processes or procedures and is solution minded.
• Able to perform analysis, mathematical calculations, and statistical evaluations

• Handwriting must be clearly legible.
• Use of computer systems including but not limited to ERP System (Deacom), Microsoft Word, Microsoft Excel, PowerPoint, and Doc Control System (QT9)

Physical Requirements

• Ability to lift up to 40 lb (e.g. quality samples, files and supplies).
• Job involves approximately 60% walking/standing and 40% sitting at desk/computer.

• Must be able to work on their feet for extended periods of time

• Must be able to navigate stairs safely.
• Ability to stand for extended periods of time and stoop, bend, kneel, crouch, balance.

Additionally, you will be eligible for a discretionary performance based annual cash bonus and to participate in our company’s equity program, plus our robust medical, dental, vision, retirement, and other benefits.