Quality Assurance Associate II

12/14/21

Bend, OR

1503

Job Summary:

Supporting the daily activities of the Quality Assurance department by ensuring GMP regulations and internal SOPs are followed throughout the manufacturing process. Responsible for reviewing and approving production records, analytical data, and internal QA documentation. Additional responsibilities include conducting risk analyses and investigations and participating in audits and inspections.

Supervisory Responsibilities:

  • Interviews, trains, and mentor’s new staff
  • May have supervisory roles for projects or subgroups of QA department
  • Initiates preventative and corrective actions
  • Performs other related duties as assigned

Duties/Responsibilities:

  • Implementation and continuous improvement of the company’s quality systems
  • Document authorship, review, and approval of SOPs, batch production and quality control (QC) records, certificates of analysis, method validations, and equipment qualifications
  • Oversight of investigations
  • Corrective and preventative actions (CAPA) program management
  • Support of internal audits, client audits and regulatory inspections, as needed
  • Responsible for controlled document issuance and archival
  • Performs quality reviews with oversight
  • Communicates quality-related information to internal team with guidance

Require Skills/Abilities

  • Excellent verbal and written communication skills.
  • Excellent interpersonal and customer service skills.
  • Excellent organizational skills and attention to detail.
  • Excellent time management skills with a proven ability to meet deadlines.
  • Strong analytical and problem-solving skills.
  • Ability to prioritize tasks and to delegate them when appropriate.
  • Ability to function well in a high-paced and at times stressful environment.
  • Proficient with Microsoft Office Suite or related software.
  • Knowledge of GMP and FDA regulations for clinical trial materials; commercial knowledge is desirable but not required
  • General understanding of change control procedures, CAPA program, investigation and root cause analysis, and good documentation practices

Education and Experience

  • Minimum of a bachelor’s degree, preferably in a scientific discipline
  • 3+ years previous GMP, QC or QA experience
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