About The Position

Onterris is hiring a Quality Assurance Associate I for its Orange, California laboratory. The role helps maintain the systems, processes, and standards that support reliable laboratory operations, with a focus on compliance, data integrity, and continuous improvement. The position is onsite, Monday through Friday, and pays $22 to $27 per hour, commensurate with experience, skills, and geographic location. The associate works with laboratory teams to review quality practices and data, support audits and corrective actions, maintain controlled documentation and training records, and help ensure laboratory workflows meet applicable standards and client requirements. The position requires hands-on laboratory bench experience in a TNI-compliant environment. Work takes place in an office and/or laboratory setting. Weekends, holidays, or after-hours work may be required based on operational demands or team scheduling.

Requirements

  • Bachelor’s degree or equivalent in a scientific field, or a combination of education, training, and experience.
  • At least 1 year of relevant experience in a laboratory or quality assurance role, or equivalent.
  • Hands-on laboratory bench experience in a TNI-compliant environment.
  • Strong understanding of scientific terminology, analytical laboratory procedures, and laboratory safety.
  • Understanding of the physical and chemical principles underlying the specified procedures for each method used.
  • Good written and verbal communication skills, including editorial and proofreading abilities.
  • Ability to collaborate with laboratory teams to gather, interpret, and document data.
  • Good organization, time management, and communication skills, with the ability to facilitate priorities effectively.
  • Proficiency in Microsoft Office, including Word, Excel, SharePoint, and PowerPoint.

Nice To Haves

  • Familiarity with TNI 2016, ISO 17025 standards, GDP, CAPA, or RCA.
  • Experience with LIMS.
  • Proficiency using data visualization tools for reports and graphs.
  • Conflict resolution skills and ability to break down organizational communication barriers.
  • Assertiveness in diagnosing problems and assessing corrective actions without assigning blame.
  • Ability to handle multiple tasks simultaneously while maintaining composure.
  • Ability to work independently and collaboratively in a fast-paced, quality-driven environment.

Responsibilities

  • Track or perform verifications of laboratory supply equipment to ensure operational reliability according to SOPs and manufacturer specifications.
  • Review logbooks, bench sheets, and data daily or weekly for Good Documentation Practices (GDP) compliance.
  • Initiate and address non-conformances for corrective actions.
  • Collect and interpret quality control data, create control charts, and audit sample reports to track laboratory performance and identify trends.
  • Track CAPA and perform or assist with Root Cause Analysis (RCA).
  • Conduct routine internal audits of laboratory processes, documentation, and facilities; prepare audit checklists and reports; and follow up on findings.
  • Communicate accurately and promptly with internal and external clients.
  • Draft, review, or revise SOPs, work instructions, forms, and other controlled documents.
  • Review and enter Proficiency Testing (PT) data and results.
  • Troubleshoot problems and support problem-solving.
  • Develop and deliver in-laboratory training on GDP, ethics, data integrity, safety, and technical topics.
  • Maintain training records and competency assessments.
  • Archive documents in accordance with SOPs.
  • Review laboratory data, workflows, and procedures for accuracy and compliance with TNI 2016, ISO 17025, client requirements, and the quality system.
  • Support external audits.
  • Communicate relevant updates to applicable people in a timely manner.
  • Follow the documented quality manual, policies, and health and safety practices, including PPE use, chemical hygiene, and waste handling.
  • Take on additional duties and responsibilities as needed to support the laboratory team.
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