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Quality Assurance

4 months ago

Bend, United States Bend Bioscience Full time

At Bend Bioscience, we are looking for colleagues with: SCIENTIFIC CURIOSITY, HONESTY, HUMOR, CONFIDENCE, HUMILITY, TRUSTWORTHINESS, RESPECT FOR CO-WORKERS, and the DESIRE TO MAKE A DIFFERENCE AND HELP PATIENTS.


Job Description:

Bend Bioscience is focused on research, development, and clinical production of non-sterile drug delivery technologies, drug products, and intermediates for the pharmaceutical industry.

In this role, you will be supporting the growth and maintenance of the Bend Bioscience Quality Management System. You will monitor and report on quality systems and implement continuous quality process improvements to support product quality, product safety, and data integrity.

You will support the QA department in pharmaceutical development work with internal and external customers to enable the Quality Management System by:


  • Engage and collaborate with cross-functional teams to evaluate processes, procedures, and activities for adherence to relevant standards, regulatory guidelines, and company procedures.
  • Assist with administration and upkeep of the following QA programs: Data Management and Integrity, Change Management, Risk Management, Deviations and CAPA, Document Management, Training, Audits, Supplier Management
  • Ensure compliance during Bend Bioscience operational activities.
  • Identify, evaluate, communicate, review, and monitor identified risks within the organization.
  • Ensure appropriate documentation of deviations, non-conformances, or complaints through appropriate investigative measures, including appropriate CAPA(s).
  • Draft and update controlled documents and maintain quality records.
  • Other duties, as required.


Characteristics:

  • Risk-based Approach
  • Collaborative
  • Problem-Solver
  • Proactive
  • Effective Communicator and Writer
  • Attentive
  • Responsible


Requirements:

  • Bachelor’s Degree, preferably BS in a scientific field with 3+ years of industry FDA-regulated industry experience.
  • Ability to apply a risk-based approach throughout product lifecycle from early-phase development to GMP clinical manufacture in a multi-use facility.
  • Analytical approach to problem-solving.
  • Ability to think critically and question preconceptions.
  • Ability to develop and foster positive and collaborative relationships with colleagues and clients.
  • Employ analytical approach to root cause analysis, risk assessments, and other Quality Events.
  • Working knowledge of cGMP (21 CFR 210, 211 and EudraLex Vol 4, Annex 13).
  • Understanding of GAMP/Data Management, QC analysis and method validation is desirable.