Who we are:
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 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.
Working within FDA cGMP regulations, perform testing for release and stability of intermediate product/starting materials, IVDs and ASR products. Generate and record testing results accurately and documented per applicable regulatory and SOP requirements. Troubleshoot equipment problems. Write and revise Standard Operating Procedures as appropriate to laboratory operations and laboratory compliance. Participate in method validation and method transfer activities. Experiences in ELISA, IHC testing, and Bioburden required.
• Perform release and stability testing according to SOPs and in compliance with cGMP regulations and guidelines.
• Data analysis using Microsoft Excel
• Maintain cGMP compliance in the laboratory.
• Write, revise and/or review Standard Operating Procedures.
• Maintain extensive knowledge of Standard Operating Procedures and GMP regulations and guidelines.
• Troubleshoot equipment problems. Recognize atypical and out of specification results, instrument malfunctions, and methodology issues and participate in the investigation process.
• Other duties may be assigned.
Who You Are:
• Minimum of 3-6 years experience in medical device, drug, and/or biologics preferred.
• Good computer skills, PC including MS Excel
• Excellent written and verbal skills
• Ability to work independently and manage multiple analyses
• Knowledge of cGMPs related to QC operations
• Knowledge & experience in ELISA, bioburden and IHC testing required.
• Experience working in ISO 13485 and/or FDA regulated laboratory
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 come2emd.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 his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.