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ByHeart

Quality Assurance Operations Manager

Portland, OR · Posted May 2
Role Description

Location: Portland, OR

Start Date: ASAP

Role Responsibilities
  • Quality Assurance Operations Manager leads a team of individuals to ensure compliance to Infant formula standards. regulations, FSMA, Certifications (not limited to: GFSI, Organic, Kosher) and Internal Quality/Food Safety Programs and Policies. Provides leadership within the facility to drive positive change through influence and example. Considered main quality liaison with Production.
  • Responsible to ensure plant compliance with the Food Safety and Quality Plans along with supporting prerequisite programs. Manages quality operations activities to help ensure compliance with all applicable state, federal regulations, and international standards for the manufacture of Food and Infant Formula products. Through cross functional teamwork with Production maintains an effective plant hygiene plan and cGMP environment.
  • Responsible for the day-to-day operations of the laboratory and ensuring good laboratory practices are implemented, documented, and sustained. Conducts oversight management for any testing that is outsourced.
  • Oversees supplier approval program and the Chemical review/approval program for the site. Actively supports and participates in the internal audit program. Performs the material / product lot release process and participates/supports as requested regulatory inspections (e.g. PDA) and / or third-party audits / certifications (e.g. SQF, Kosher, Organic)
  • Participates/supports investigations relating to non-conforming events (including product complaints) driving to root cause(s) and effective resolution (corrective actions).
  • Monitors compliance to customer expectation and specifications, communicates any issues/concerns and maintains audit readiness / preparedness for customers, regulatory agencies, and visitors/contractors.
  • Assists / supports in the execution of validation processes and improvement projects.
  • Assists / supports facility's management of the change control program to enable robust risk assessment and decisions.
  • 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.
  • Provides support to quality leadership during unplanned events or emergencies.

Skills & Qualifications
  • Infant Formula or Food (Dairy) manufacturing experience preferred.
  • Knowledge of principles and practices of supervision, training, and personnel management.
  • Accuracy and thoroughness in completion of duties is crucial to success
  • Able to organize and prioritize resources to achieve goals
  • Able to multi-task; able to keep organized records; able to work with accuracy and attention to detail.
  • Able to perform analysis, mathematical calculations, and statistical evaluations.
  • Able to communicate clearly and effectively, both verbally and in writing.
  • Able to work in collaboration effectively, foster good teamwork and promote a team environment
  • Able to present options and ideas to current processes or procedures and is solution minded.
  • Able to handle challenging or conflict situations with tact and professionalism.
  • Able to adapt and manage to change effectively.
  • Able to take initiative in performing job.
  • Able to perform task and duties without constant supervision.
  • Background in overseeing laboratory facilities and equipment experience.
  • Bachelor's degree required in Food Science, Biological Sciences or related field
  • Working knowledge of 21 CFR Part 106, 107, & 117. 1-3 years of supervisory experience. 2-5 years of experience in food processing environment (Ideally Dairy and a plus if Infant Formula).
  • SQF Practitioner certified or obtained within first 90 days.

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.
  • Regular need to go up/down stairs.
  • Ability to stand for extended periods of time and: stoop, bend, kneel, crouch, balance, climb as part of audit routine.

Regulatory Requirements
  • Adhere to all safety policies and procedures, follow cGMP's, and work in a manner consistent with all corporate and regulatory, food safety, quality and sanitation requirements.
  • Will comply with all applicable federal, state, and local standards for the manufacture of infant formula and other non-infant nutritional foods.

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.