Quality Specialist, Product Complaint Investigations in Fremont, CA at Apex Life Sciences

Date Posted: 7/12/2018

Job Snapshot

Job Description


Apex Life Sciences is seeking a senior-level individual contributor to work independently and responsible for establishing, maintaining and managing quality systems with a focus on the Product Complaints Process.

Duties:

  • Supports the development, implementation and maintenance of internal process for complaint handling
  • Responsible for oversight of the Product Complaint process: Development and maintenance of all SOPs related to Product Complaint process
  • Tracks, monitors and reports related metrics/KPIs
  • Product Complaint record trending and analysis
  • Partners with internal stakeholders and internal network to drive consistency and continuous improvement of quality systems
  • Investigate product complaints reported for and Client based products
  • Coordinate investigative activities with internal SMEs and external lab/facilities
  • Key User/Point of Contact for system used to record and track complaint records (TrackWise)
  • Communication with End Users in support of timely Complaint related activity completion
  • Develop and provide process and system training for site staff involved with the Product Complaints process
  • Directly interfaces with customers and may interact with regulatory agencies regarding company quality systems, procedures and documentation.
  • Maintains current knowledge of the regulatory environment and requirements regarding GMP Quality Systems in the pharmaceutical/medical device industry.
  • Continuously ensures Quality System processes incorporate updated information and industry learning trends.
  • Support maintenance of site investigation and CAPA process, in alignment with site Deviation/CAPA process owner
  • Communication with Deviation, CAPA and Investigation End Users in support of timely Complaint related activity completion
  • Support of KPI and trend analysis as well as report creation for Deviation/CAPA Process Develop and deliver training for Complaint, Deviation, CAPA and Investigation related processes and systems
  • Proactively leads initiatives to improve quality systems in the organization, develops SOPs and KPIs for the business
  • Proactively engages the site to uncover issues and concerns relating to quality systems, and facilitates resolution and continuous improvement
  • Participates in inspection readiness activities
  • May perform Quality risk assessments
  • May cross-train in other disciplines within Quality Participates in and lends expertise to projects and operational excellence improvement efforts
  • Identifies, designs, and implements process and system improvements
  • Serves as the Quality representative on cross-functional and multi-site project teams
  • Represents Quality in cross-functional meetings, provides subject matter expertise, and makes sound decisions

Qualifications:

  • Bachelor's degree in a relevant discipline required; advanced degree preferred.
  • 8+ years of general experience in the pharmaceutical industry with direct experience in a cGMP manufacturing environment
  • 5+ years experience in a cGMP manufacturing, quality systems or process/continuous improvement role required
  • Comprehensive knowledge and understanding of regulatory requirements as governed by cGMP and regulatory agencies (FDA, EMA, TGA)
  • Strong proficiency with TrackWise or related Quality System applications.
  • Strong facilitation skills a mus
  • Demonstrated history of successful development and implementation of robust quality systems and processes
  • Proven ability to work creatively and analytically in a problem-solving and process-oriented environment.
  • Proven ability to work in a collaborative, team-based environment dependent upon effective teamwork to achieve goals and company objectives.
  • Excellent leadership, communication (written and oral) and interpersonal skills required.
  • Proficiency in the use of Microsoft Office Software including Word, Excel, PowerPoint, Visio, Access, Project
  • Six Sigma and/or Lean experience preferred
  • Proficiency in the use of Microsoft SharePoint is a plus

***For immediate consideration, please email your updated resume to bfreeman@apexlifesciences.com with 'Quality Specialist, Product Complaint Investigations' in the subject line.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, 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 employeeservices@apexsystemsinc.com or 844-463-6178.