Spec, Quality Assurance Associate Sr
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POST DATE 9/20/2017
END DATE 4/27/2018
JOB DESCRIPTIONA career with MilliporeSigma is an ongoing journey of discovery: our 50,000 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.
Who we are: MilliporeSigma is the North American life science brand of Merck KGaA, Darmstadt, Germany - a leading science and technology company. It offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science.
Your role: Ensure that all aspects of product release meet analytical, production, packaging and labeling specifications in accordance with established quality systems. Support the maintenance, development and improvement of GMP quality systems, such as auditing (internal, supplier, and customer), training, process validation, cleaning validation, equipment qualification, environmental monitoring, water monitoring, change control, complaint handling, and documentation control.
* Review executed GMP batch documentation to determine whether process and laboratory results meet the predetermined acceptance criteria for release
* Report all process deviations and/or laboratory OOS results
* Write, review, and/or approve Operating Procedures, Manufacturing documents and other QA controlled documents under Quality Management System (QMS)
* Interact with the production and laboratory personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers
* Support quality systems such as internal and external audits, deviation, CAPA, change control, and customer complaints
Who you are:
* Education and Experience:
* Bachelor s degree in a Life Science or related field with minimum 3 years of experience in GMP manufacturing, validation, QA, QC, or other functional area applicable to the job
* Associates degree with minimum 3 years applicable GMP experience in the specific QA job function as deemed appropriate by QA Management or at least 5 years of experience with a degree not specified in Life Science.
* Knowledge and Skills:
* General understanding of Good Manufacturing Practices and ISO 9001:2008
* Good computer skills, including proficiency MS Word and MS Excel
* Good time management skills
* Excellent interpersonal skills for interacting with many internal departments
* Ability to organize and prioritize tasks effectively
* Capacity for independent work
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.