Failure Investigation Supervisor

Posted 09 Apr 2019

Carlsbad, California - United States

Req Id 190378

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
 


Your Role:

This position in the Technical Operations department is responsible for supervising, assisting and supporting where necessary the root cause analysis of technical failures that occur during the manufacturing of viral vector drug substance or drug products. Our investigations team may conduct personnel interviews, consult with subject matter experts, propose and/or conduct experiments to further understand failure modes. They are responsible for technical report writing, proposing appropriate corrective actions and potentially communicating with customers on investigation status. As the Supervisor of this team, you will be responsible for oversight of the team and the investigations they manage. Effective leadership will require a relevant technical background and a willingness to roll up your sleeves and work side by side with your team when issues are more complex. In addition, you will be analyzing and reporting relevant metrics, and taking appropriate steps to ensure that KPIs remain on track. You will be tasked with creating and supporting a best-in-class investigation team by creating appropriate training opportunities for yourself and your team by building relationships throughout the organization and using those relationships to build a comprehensive understanding of technical challenges. You should be competent in cGMP requirements, root cause analysis tools, risk-based analysis and written and verbal communication skills. This role may have 1-3 direct reports

  

ESSENTIAL JOB FUNCTIONS

•Strong supervisory skills: •Provide technical expertise to the site to ensure that investigation corrective and preventative actions are complete, thorough, accurate, and timely

•Expertise in root cause analysis, impact assessments, technical report writing

•Oversight of relevant nonconformance KPIs •Weekly dashboard update

•Escalation of issues as required

•People management •Creating/supporting a cohesive, and competent investigation team

•Development of a training strategy to ensure team competence in RCA tools and the ability to deliver investigations for all areas within the facility

•Create development paths for team to ensure career growth and opportunities

•Must be able to interface with people effectively, both internally and externally

 

ADDITIONAL LOCAL NEEDS:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl.
  • The employee may frequently be required to enter the clean room environment.
  • The employee must be able to work off-shifts, weekends, and additional hours as required. The employee must have the ability to perform very complex tasks with attention to detail.

 

Who You Are:

 Basic Qualifications:  

  • Bachelors in Life Sciences, Engineering or related field of study from a four year college/university
  • 3 years’ experience working in pharmaceutical/GMP environment

 

Preferred Qualifications:

  • Proven ability to conduct investigations, writing deviations and CAPA’s
  • Proven ability to apply RCA tools (Fishbone Diagrams, 5 Whys, etc.)
  • Good analysis, troubleshooting, investigation and communication skills, especially both written and verbal
  • Thorough understanding of the biopharmaceutical manufacturing process, current Good Manufacturing Practices and CAPA
  • Ability to put complex thoughts and issues into writing in such a manner than an educated, but uniformed reader can understand and make decisions based on the written investigation report

 


What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

 

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

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