Mountain View, California

Title: Associate Compliance Investigator - Scientific

Location: Mountain View, CA

Job Duties/Responsibilities:

  • Determine causes and develops preventative actions of Deviations, Non-Conformances, OOS, OOT, field complaints and environmental excursion investigations.
  • Conduct investigations to true root cause using appropriate investigation tools. Benchmark industry standards to develop, advocate, and implement investigative and impact assessment tool sets. Implement effective preventive actions to prevent recurrence.
  • Handle multiple investigations in different stages of the process to efficiently meet compliance deadlines and product release dates.
  • Collaborate with cross-functional teams to develop and track CAPA plans.
  • Track and create appropriate trending rules that trigger corrective actions.
  • Effectively utilize change management approach.
  • Develop materials to train and educate personnel on writing problem statements and use of root cause analysis tools, discrepancy and deviation process. Champion CAPA plans and implementation.
  • Provide communication plan for on-going deviations CAPA s.
  • Effectively create and execute communication plan for CAPA s and on-going deviations to responsible parties.
  • Conducts timely completion of deviations, CAPAs, and Change Controls as necessary. Ability to comply with quality standards.

Qualifications:

  • Bachelor of Science in a Quality / Process related field Science/Engineering.
  • Minimum of 3 years experience in GMP Operations and/or Quality Assurance in Cell Therapies, Biotechnology or Bio-Pharma.
  • Knowledge of Root cause analysis in pharmaceutical or FDA regulated operation preferred.
  • Working knowledge of cellular therapy and/or GMP procedures.
  • Relevant IT skills able to work with Microsoft Word, PowerPoint, Visio, Project, and Excel.
  • Experience using e-Quality Management Systems preferred.
  • Minimum Required Training GMP Training Quality Systems Training Change Control, Deviation/CAPA Competencies/Candidate Profile. 
  • Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment and independently.
  • Analytical and problem-solving skills Strong written and oral communication skills Flexible and able to adapt to company growth and evolving responsibilities Integrity, accountability and strong dedication to regulatory compliance.
  • Continuous improvement mindset.

For immediate consideration apply today!

Questions? Please reach out to Jessica Rubano at jessica.rubano@kellyscientific.com



You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

Why Kelly®?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

]]

Mountain View, California

Why Kelly - Since 2011 we have placed over 16,000 Veterans

Need More?

Kelly applies targeted recruiting initiatives to the Veterans population (in all stages of transition) by aligning customer defined requirements with military skills and experience.  The transition from military to civilian life can be stressful and complex for veterans, and our staff is trained to assist in this transition.  Unlike our competition, Kelly places these resources without geographic or industry constraints, offering our customers and our employees greater flexibility.  Kelly has a wide variety of local opportunities, for Veterans and their spouses, within our workforce solutions as well as national recruiting programs on behalf of our customers.  Kelly’s leading placement opportunities for Veterans are within Information Technology, Engineering, Science, Light Industrial and Call Center.

Our specially trained Veteran recruiters are armed with a number of tools to help Veterans obtain roles that match their potential including skill translation tools, leading Veteran- centric job boards and Veteran/spouse social media networks, among others.

Through Kelly’s vast branch network, we are closely located to the majority of major military installations across the United States.  Kelly recruiters participate in onsite and virtual military career fairs as well as advertise through local and national Veteran job boards.  In recent years, over 150 Kelly branches have worked directly with their local military installations to recruit spouses and transitioning personnel.  These teams not only engages with transitioning talent from local bases, but also have a strong focus on Veterans in areas where the military has identified high Veteran unemployment. This approach ensures that military talent is engaged and shared across the centralized military recruiting team and documented in a centralized database, so that other Kelly locations can benefit from hiring or relocating this valuable pool of talent.

Our focus on military recruiting is a win on multiple levels. Kelly gains top talent with the skills needed to excel; our clients receive the benefit of that talent to help them compete in an ever challenging business landscape; and Veterans receive gainful employment in line with their skills and abilities to ease the transition to the next phase of their lives.

A People Company, Staffing the World

Kelly founded the temporary staffing industry in 1946, and has maintained a leadership position through the years based on a valuable premise: we invest in people. Today that focus benefits our customers wherever they operate around the globe - in a growing number of specialized fields. And we’ll continue to meet the evolving challenges of workforce flexibility with staffing solutions tailored to your precise business needs, both locally and worldwide.

Similar jobs