ByHeart is hiring a

Quality Document Control Specialist

Portland, United States

ByHeart is an infant nutrition company built from the ground up to deliver real innovation on behalf of babies and parents. Our mission is simple: make the best formula in the world. That’s why we studied the latest breast milk science, worked directly with suppliers we know and trust, set uncompromising quality standards, developed our own small batch blending process, built our own manufacturing facilities, and conducted a groundbreaking clinical trial. Our goal is to create a future where all parents feel amazing about feeding their baby—no matter how they do it.

When we launched our Whole Nutrition Infant Formula in March 2022, we were the first new U.S infant formula manufacturer in 15 years. Since then, we’ve been leading the way in a lot of ways.

We’re…

  • The only U.S.-made infant formula to use organic, grass-fed whole milk
  • The first and only U.S. infant formula company to add the two most abundant proteins found in breast milk—alpha-lac and lactoferrin—to our ingredients list
  • The first infant formula company to receive Clean Label Project’s Purity Award (and we test for 700 contaminants vs the required 400)
  • We ran the largest clinical trial by a new infant formula brand in 25 years—clinically proving our benefits vs a leading infant formula like:
    • Less spit up
    • Softer poops
    • Easier digestion
    • More efficient weight gain
    • Enhanced nutrient absorption
    • Longer stretches between nighttime feeds*

With >$250M in funding, we’re shifting the industry forward—and this is just the beginning. Help us build a future where all parents can feel amazing about feeding, by joining our growing team of >275 people that stretches across the country.


We're proud to offer competitive, family-first benefits, including but not limited to: 

  1. Health insurance for the whole family: medical, dental, & vision insurance covered 100%, with 90% coverage for your family.
  2. Flexible paid time off: plus 12+ company holidays, and 2 floating holidays to use at your discretion!
  3. 16-weeks of fully-paid parental leave and new parent support: free 1-year supply of formula, cozy feeding suites, and paid pumping time.
  4. Up to 6% 401(k) Match to help you plan for your future.
  5. Company equity for every employee: because when we succeed, we succeed together!

Visit our site to learn more, and check out some recent press on ByHeart:

*based on data from infants at approximately 4 months of age


 

Job Description

The Quality Document Control Specialist coordinates activities to ensure compliance with company's policies and procedure to meet GMP and regulatory guidelines. High focus on reviewing, editing, and releasing GMP documentation. Support documentation release for Blendhouse Portland facility departments.

Essential Duties & Responsibilities

  • Management of the Document Control System, Intelex, QT9
  • Works closely with department personnel to ensure release of key process documentation including but not limited to: batch records, quality policies and departmental procedures.
  • Reviews, edits, and releases procedures, work instructions and forms following company's document change procedure.
  • Responsible for formatting, proper spelling, and clarity of text for any written documents submitted to Document Control.
  • Manages physical inventory of documents control including documentation in the electronic database of documentation and outside storage.
  • Assist with documentation needs during audits.
  • Documents and tracks documentation numbering system.
  • Train and assist team members in the use of the document control system.
  • Assist with training on newly released procedures, work instructions and forms.
  • Assists with other Quality Assurance and Regulatory Compliance functions as needed.

Competency & Skill Requirements

  • 5 years hands-on QA experience in a GMP manufacturing environment
  • Attention to detail.
  • Must have strong trouble shooting and problem-solving skills
  • Good communication skills (oral and written)
  • Ability to act independently, accept supervision and work quickly and accurately in a fast-paced environment
  • Fast, efficient, high-level user of MS Word and Excel

 

Education & Experience Requirements

  • College degree or BS, preferably in biological science.

 

Physical Requirements

  • Sitting
  • Standing
  • Walking
  • Bending/ Stooping

Regulatory Requirements

  • Adhere to all safety policies, procedures and work in a manner consistent with all corporate and regulatory, food safety, quality and sanitation requirements including HACCP, SQF, OSHA, GMPs, on-site SOPs, etc.
  • Will comply with all applicable federal, state, and local standards for the manufacture of infant formula and other non-infant nutritional foods
  • We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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