Senior Quality Systems Specialist in Seattle, WA at APEX Systems

Date Posted: 11/13/2019

Job Snapshot

Job Description

Job #:  1025839

Apex Systems is looking for a Senior Quality Systems Specialist for a biotech client in South Lake Union! The Sr. Specialist Quality Systems is a full-time position responsible for providing oversight and guidance for assigned quality systems and compliance activities within one of our client's divisions. 

This includes facilitating quality systems processes, in addition to serving as a key Quality Systems resource for corporate office operations and ensuring compliance with applicable policies, procedures and regulatory requirements.

This position also works cross-functionally to ensure that quality systems processes are harmonized across multiple facilities and relevant process improvements are identified, documented and implemented. The role will serve as an SME and superuser for one or more Quality Systems. Please see below and apply if interested!
  • Contribute to the writing, coordination, review, approval and maintenance of the Qualitry Systems Procedures (SOPs) and Work Instructions (WP)
  • Provide QA input to functional groups to evaluate and ensure proper closure of deviations, investigations, complaints, change controls and CAPAs
  • Assure the deliverables, milestones, and objectives for Quality Systems are developed to ensure success for the program(s).
  • Ensure that any changes or impacts to the systems are communicated and agreed to by sites, teams and project sponsors.
  • Superuser role for the Quality Systems that fall under hers/his responsibility.
  • Develop and conduct user training for Quality Systems for Corporate Office personnel. This includes new hire and routine training for Quality System elements (i.e. Deviations, CAPAs and Change Control, Quality Risk Management, Document Control).
  • Support and train cross functional groups with guidance on deviation management to ensure accurate reporting, investigation, root cause analysis and corrective actions.
  • Perform routine and ad hoc Quality Systems metric reporting and analysis for the Corporate Office data.
  • Prepare metrics and perform periodic trend analysis in support of management review.
  • Provide communication as to the status of Quality Systems deliverables to customers, management and stakeholders.
  • Act as QA Subject Matter Expert (SME) to support cross functional groups for Quality Systems functions.
  • Act as a QA SME during internal, external and regulatory audits
  • Support internal, external audits and regulatory inspections. ( data gathering, interviewing or escorting auditors during the audit)
  • Participate in the Risk Management program, including updating risk analyses, participating in applicable teams and maintaining Risk Management documents.
  • Support corporate requests for compliance and regulatory assessments.

  • 3+ years Quality experience with one or more years of experience within Quality Systems
  • Strong technical writing skill set and be able to critically review reports while effectively inputting and expressing Quality principles.
  • Innovative, proactive, and resourceful; committed to quality and continuous improvement.
  • Ability to work effectively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
  • Able to manage multiple priorities.
  • Strong project planning skills.
  • Strong computer skills with MS Office (e.g. Word, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System)
  • Previous work experience in the following: quality assurance, CAPA, change control, deviation management, compliant handling and compliance.
  • Experience interacting with FDA or other regulatory agencies
  • Must complete tasks independently, notify supervisor of decisions outside of established processes and the ability to build an internal network.
  • Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships 
  • Experience in a GxP (GLP, GMP or GCP) regulated environment

EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.