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Quality Document Control Specialist

Portland, OR
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.