Sr. Specialist, Quality Complaints
6701 Kaiser Drive Fremont, CA 94555
Bayside Solutions is seeking a Sr. Specialist, Quality Complaints to be part of our client’ s team in East Bay Area. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Sr. Specialist, Quality Complaints:
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Responsible for oversight of the Fremont 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 BI Network to drive consistency and continuous improvement of quality systems
- Fremont Site Complaint Officer:
- 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 BI Fremont' s 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.
- General Quality System responsibilities:
- 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 Fremont 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
Summary of Qualifications:
- Bachelor' s degree required in a relevant discipline; advanced degree preferred.
- Minimum eight years of general experience in the pharmaceutical industry with direct experience in a cGMP manufacturing environment
- Minimum five 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