A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 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.
The Carlsbad Gene Therapy Viral Vector Manufacturing is a contract manufacturing site that produces drug substance and drug products for gene therapy and oncology applications.
Determines the root cause and corrective action for deviations identified in various production processes. Ensures that investigations identify true root cause and appropriate corrective actions in order to prevent recurrence.
In this role you will; Provide technical expertise within the context of defining the problem statement, assessing the impact, identifying root cause, and determining corrective actions, Communicate cross-functionally effectively and professionally to lead investigative discussions, Work independently and as part of a team to manage multiple projects simultaneously. You will need to have the ability to distill complex thoughts and issues so that an educated, but unfamiliar reader can understand and make decisions based on the written investigation report, be organized and detail oriented as well as an active listener and communicator.
The work environment characteristics 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 be required to enter the clean room environment. The employee must have the ability to perform very complex tasks with attention to detail.
Who You Are:
- Bachelor’s degree in life sciences or related scientific discipline
- 2+ years’ experience in regulated environment
- Experience with CAPA’s highly preferred
- Experience with deviation tracking system (e.g. Trackwise) and conducting investigations highly preferred
- Thorough understanding of the biopharmaceutical manufacturing process, current Good Manufacturing Practices highly preferred
- Experience working with quality tools (Fishbone Diagrams, 5 Whys, etc.)
- Good analysis, troubleshooting, investigation and communication skills, both written and verbal
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.