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Serán BioScience

Posted 1 month ago

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Quality Assurance Associate II/III -Quality Management System

Bend, OregonOn-siteFull-time

AI Summary

Quality Assurance professional supports GMP-driven QA programs, document control, CAPA, audits, and eQMS administration in a pharmaceutical manufacturing setting.

About this role

Serán BioScience is searching for an experienced Quality Assurance Associate to support quality systems programs. As a Quality Assurance Associate, you will be responsible for performing the day-to-day tasks of the QA Department in a GMP facility manufacturing pharmaceutical products. Tasks include supporting quality system programs such as document management, training, and quality event programs. Additional responsibilities include assisting in the maintenance of the electronic Quality Management System, conducting risk analyses and investigations, and participating in audits and inspections. Preference will be given to candidates within the pharmaceutical industry, while those with Quality oversight experience encouraged to apply.

Duties and Responsibilities

  • Supports the implementation and continuous improvement of the company’s Quality systems
  • Assists in monitoring of Serán quality systems through trending and metrics analysis
  • Supports the management of Serán’s quality systems through program oversight and eQMS administrative functions.
  • Document authorship, review, and approval of SOPs, reports, and quality records
  • Oversight of investigation and CAPA program management
  • Supports internal audits, client audits and regulatory inspections, as needed
  • Other related duties as assigned

    • Required Skills and Abilities

  • Knowledge of GMP and FDA regulations for clinical trial materials preferred
  • Excellent verbal and written communication skills
  • Excellent time management skills with a proven ability to meet deadlines
  • Excellent organizational skills and attention to detail
  • Demonstrated ability to collaborate and work in cross-functional teams
  • Scientific curiosity and willingness to learn
  • Demonstrated experience in characterization and analytical techniques relevant to the pharmaceutical industry
  • Demonstrated experience with advanced laboratory and data analysis skills preferred
  • Strong analytical and problem-solving skills

    • Education and Experience

  • Minimum of a Bachelor's Degree, preferably in a scientific discipline
  • 3+ years previous manufacturing, quality control, or quality assurance experience
  • Working knowledge of Veeva and/or SAP preferred

    • Physical Requirements

  • Prolonged periods of sitting or standing at a desk and working on a computer
  • Must be able to lift up to 15 pounds at times
  • Ability to wear required personal protective equipment (PPE), including safety glasses, hearing protection, hard hat, and safety shoes
  • Adheres to consistent and predictable in-person attendance

    • Skills

    Analytical TechniquesCAPAClient AuditsData AnalysisDocument ManagementEQMSFDA RegulationsGMPInternal AuditsQA InvestigationsQMS AdministrationQuality EventsQuality RecordsRegulatory InspectionsRisk AssessmentSAPSOP AuthoringSOPsTrend AnalysisVeeva

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