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27 days old

Associate Compliance Investigator

Kelly Services
Mountain View, CA 94035
**Kelly Services is currently seeking an** **Associate Compliance Investigator** **for a Direct Hire role in Mountain View.**


**Job Title** : **Associate Compliance Investigator**


Pay: $72 85k depending on experience


**Job Description** :


Conducts investigations, including but not limited to deviations, environmental excursions, non-conformances, discrepancies, etc. to improve the processes by implementing corrective and preventive actions (CAPAs) to ensure compliance. This position is regular, full-time and exempt.


**Essential Functions and 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 & CAPAs.

Effectively create and execute communication plan for CAPAs 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




**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 interestsits 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, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-11-10 Expires: 2022-01-01

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Associate Compliance Investigator

Kelly Services
Mountain View, CA 94035

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