Quality Assurance Associate Specialist

Posted 08 Nov 2019

Lenexa, Kansas - United States

Req Id 199908


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.

Your Role:


Ensure that all aspects of product manufacture meet production, packaging, labeling, and test specifications in accordance with established quality systems. Support the maintenance, development and improvement of GMP quality systems, such as auditing, training, and change control.  Make batch release determination, and generate CoA and other specified batch documents.

The core responsibilities for this role are comprised of but not limited to review and release of raw materials and finished products in a timely manner, assuring any lot deviations and Out of Specifications (OOS) are completed and closed. Performing label approval, label generation, and review of daily QA paperwork to include charts, monitoring exhibits, and environmental records, and reviewing batch records prior to production. This role will also be responsible for answering questions from internal and external customers, participating and leading cross-functional deviation investigations, root cause analysis, and CAPA plan development in a timely manner, maintaining CAPA tracking and performing effectiveness check as applicable, assisting in customer audits including opening/closing meetings, tours, document reviews and any follow-up activities as necessary, and assisting periodic internal audits to meet corporate and ISO requirements. In addition, this role will be responsible for approving master batch records and batch records, assuring accuracy and completeness and resolve any discrepancies in documentation, taking part in and contributing to a safe working environment by following corporate and departmental safety regulations, performing new hire, ISO, and GMP training, and maintaining Site Quality filing systems.


Who You Are:


Minimum Qualifications:


  • Bachelor’s Degree in life sciences with a minimum of two (2) years direct Quality Assurance experience or an equivalent combination of education and experience.
  • An understanding of commercial Quality systems and the application of them in a manufacturing environment.
  • Effective oral and written communication skills.
  • Good customer service skills and the ability to negotiate win-win outcomes.


Preferred Qualifications:


  • Two (2) or more years experience in a Pharmaceutical, Biopharm, or other Healthcare industry with demonstratable familiarity of cGMP’s, cGLP’s and/or related ISO requirements.
  • Experience using QMS software such as TrackWise or SAP QN.


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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