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Role Description

The Quality Lab Supervisor is responsible for the overall direction and coordination of the microbiological, physical and chemical analysis on raw materials and food products from various stages of the manufacturing process as directed by the Director of Quality and provides assistance to the operations team. Provides support and assistance to the Director of Quality by performing auditing and inspection functions for post-cleanup and sanitation. Accuracy, reliability, and expediency are essential to the successful completion of the duties of a Quality Lab Supervisor.

Reports To: Director of Quality

Location: ByHeart Manufacturing Facility in Portland, OR

Start Date: ASAP

Role Responsibilities

• Manage, Supervise and Coordinate QA Laboratory Personnel and QA Laboratory Activities.
• Responsible for the day-to-day operations of the laboratory and ensuring good laboratory practices are implemented, documented, and sustained

• Direct and coordinate training of QA Lab Technicians in accordance with regulatory guidelines.
• Oversee all chemical and physical analysis (including flavor checks) on product, ingredient and control samples according to laboratory procedures that are performed by the Lab Technicians.
• Understand the concepts of each analysis, anticipate the result and follow through on any deviation.

• Complete Event Reports for non-conforming results
• Oversee Instrument Calibration and preventive maintenance programs as it relates to equipment used in the laboratory.

• Record all product analyses according to laboratory protocols including data entry on a computer system.
• Conduct oversight management for any testing that is outsourced.
• Procure Laboratory and Quality Assurance Supplies
• Clean and maintain all equipment/materials used while keeping the laboratory clean and organized.

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

• Communicate effectively all critical information regarding analysis, procedures, and test results.
• Handwriting must be clearly legible.
• Follow all laboratory and plant GMP and safety procedures according to company guidelines.
• General Plant QA responsibilities may include (but are not limited to): collection and distribution of product and ingredient samples, environmental swabbing, ATP swabbing, air sampling, water sampling, allergen testing, and safety checks.
• Support Customer Complaint Investigations, driving to root cause(s) and effective resolution (corrective actions)
• Track and report on plant quality key metrics and trends & prepares / issues Monthly Quality reports to management on an ongoing basis to ensure transparency.
• Participate 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

• Bachelor’s Degree in Biological Sciences, Food Science or related field is preferred
• Minimum of 2-5 years’ experience in a lab environment with demonstrated leadership experience. Infant Formula or Food manufacturing 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).
• Competency in performing functions that ensure product quality, safety, and compliance to applicable SOPs and GMP regulations such as data entry, results from assessments, internal audits, CAPA resolutions, and records review
• Must be able to perform analysis, mathematical calculations, and statistical evaluations
• Must be self-disciplined, a team player, and be able to handle emergency situations common to the operation
• Must be able to maintain and display personal cleanliness and follow GMPs as described in company guidelines
• Must be able to write clearly and in an organized fashion
• Must be able to use 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 80% walking/standing and 20% 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.