We are looking for a Sr. Specialist, Quality Complaints, working in the Pharmaceuticals & Medical Products industry in Fremont, California, United States.
General Quality System responsibilities:
Supports maintenance of site investigation and CAPA process, in alignment with site Deviation/CAPA process owner
Communicates with Deviation, CAPA and Investigation End Users in support of timely Complaint related activity completion
Supports KPI and trend analysis as well as report creation for Deviation/CAPA Process
Develops and delivers 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
The pay we are offering is 49 per hour. This position may present an opportunity to go permanent.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Minimum 8 years of general experience in the pharmaceutical industry with direct experience in a cGMP manufacturing environment
Minimum 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
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 (Word, Excel, PowerPoint, Visio, Access, Project)
Six Sigma and/or Lean experience preferred
Proficiency in the use of Microsoft SharePoint
Bachelors degree required in a relevant discipline (advanced degree preferred)
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.