Quality Assurance Validation Specialist
Posted on: February 14, 2019
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.
The Quality Assurance Validation Specialist serves as the contact for quality projects and continuous improvement efforts regarding validation and quality risk management. The Quality Assurance Validation Specialist supports ongoing validation efforts and quality systems responsibilities in support of the manufacture, testing, and release of formulated drug substance. This role contributes to the development of concepts and techniques specific to validation and risk management. This role is paramount to ensure the efficacy and quality of our manufacturing processes which will ultimately yield safe drug products for patients.
* Applies and enhances existing programs for the validation of new production and laboratory equipment and utilities, including major capital projects.
* Drafts, reviews, executes and approves protocols and reports related to equipment and utilities validation. This includes deviation reporting during execution.
* Ensures that the site Validation Master Plan remains current and aligned with corporate policies as it pertains to equipment and utility system validation.
* Identifies and implements improvement opportunities for established Quality Systems, processes, procedures, and training to support corrective action, preventive action (CAPA), Change Control, Deviation, Risk Management, and Investigation processes.
* Collaborates significantly with cross functional groups, including Quality, Manufacturing, Process Development, Facilities, and Regulatory Affairs.
* Bachelor's Degree in technical discipline (e.g. biotechnology, biology, engineering, chemistry)
* Associate's Degree in technical discipline (e.g. biotechnology, biology, engineering, chemistry)
* 3+ years experience in GMP environment
* Knowledge of calibration methodology, equipment, and instruments.
* Knowledge of software including: CAD, Minitab, and Microsoft Office
* Experience with use of quality systems and processes in a regulated environment (GLP, cGMP, ISO)
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfill 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.
Keywords: MilliporeSigma, Madison , Quality Assurance Validation Specialist, Other , Madison, Wisconsin
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