QA Associate II

Pacific Biomarkers Seattle , WA 98119

Posted 2 weeks ago

The QA Associate II provides support to quality assurance and process improvement processes by receiving, reviewing for exceptions and errors, filing, archiving, and transferring data to and among files and database fields. You will participate in collecting data to support mandated reporting and assist with performance analysis, in addition to participating in internal audits of document and data control, best practice, and safety/occupational hygiene.

  • Maintains document control systems and implements the appropriate quality-related policies and procedures required for regulatory compliance.
  • Performs file and file system development, setup, and maintenance functions that support overall document control.
  • Reviews policies and procedures for regulatory compliance and consistency.
  • Provides and conveys policies and procedures for business and technical practices throughout the company.
  • Orients affected departments and work teams of changes and intent of SOP.
  • Participates in internal audits. Conducts study specific audits (e.g. data, report, critical phase) and equipment / computer system validation deliverables review. Perform audits of well-defined and documented processes and business practices within the company.
  • Highlights areas of non-compliance, data and documentation exceptions and errors during internal audits. Participates in analysis of audit findings.
  • Maintains the internal audit schedule. Records information in common formats according to QA analysis needs and communicate audit findings to applicable staff.
  • Conducts audit / physical inspection of contract laboratories that provide services to the company for compliance with applicable regulatory and business contract requirements.
  • Implements corrective action and preventative action (CAPA) follow-up to audit exceptions and occurrences. Ensures actions are adequately documented and completed. Participates in analysis of CAPAs.
  • Participates in root-cause analysis and other problem solving/investigation activities to ensure that effective corrective/preventive actions are implemented, and processes are improved.
  • Develops and maintains and archives standard operating procedures.
  • Maintains internal and external document archives
  • Maintains records for in-house training and continuing education for laboratory and laboratory support personnel and assists with identifying training needs and continuous improvement of training activities.
  • Assists management in developing and providing applicable safety and regulatory/quality-related trainings.
  • Conducts routine surveillance of physical premises for safety related issues and communication of emergency procedures.
  • Serves as a primary resource for maintenance of company safety policies and procedures.
  • Researches and recommends additional systems and procedures for data and document control, storage, and retrieval that contribute to improved efficiency.
  • Performs other QA duties as assigned that support the overall objective of the position.
  • Supports QA management in the preparation and hosting of client audits.
  • Supports QA management in certification/accreditation process and maintaining certifications/accreditations, as applicable.
  • Assists other departments in quality issues as required
  • Escalates any potential risks to QA management.

Requirements

  • Bachelors degree in medical technology or equivalent technical field such as science plus 6 years of clinical lab and/or quality assurance and process analysis experience.
  • The position requires in-depth knowledge of quality assurance procedures including documentation of work processes, audit of scientific documents and data, and alphanumeric filing techniques.
  • Requires working knowledge of quality assurance audit procedures including the steps for corrective and preventative action.
  • Requires working knowledge of documentation requirements for regulatory compliance and licensing agencies.
  • Requires working knowledge of laboratory safety practices.
  • Requires well-developed knowledge of and skill at using common office productivity applications such as spreadsheets, statistical applications, and presentation graphics.
  • Requires sufficient language and writing skill to read and classify technical and scientific documents.
  • Requires sufficient math skills to understand test and statistical data. Requires well-developed human relations skills to convey technical concepts, consult with, and conduct training to a range of internal contacts for purposes of lab technical training, data and document control, and problem solving.

Benefits

If you are interested in working in a dynamic biotechnology environment that is challenging, rewarding and a source of personal pride and growth, were interested in hearing from you! Pacific Biomarkers is located in Seattle, surrounded by mountains, forests and waterways of the Pacific Northwest.

  • Competitive Salary
  • Medical, Dental & Vision Plans
  • Life Insurance, AD&D
  • Two weeks paid vacation
  • Ten days paid holidays
  • STD (Short Term Disability) benefits
  • Pre-Tax Flexible Spending Accounts
  • 401K Plan
  • Lovely lower Queen Anne location in Seattle
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QA Associate II

Pacific Biomarkers