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Quality Assurance Specialist

Posted 31 May 2018

Lenexa, Kansas - United States

Req Id 176706

Details

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.


Your Role

Ensure that all aspects of product release meet analytical, production, packaging and labeling specifications in accordance with established quality systems. Lead the execution and improvement of GMP quality systems such as Deviation, CAPA, internal auditing, customer audits, training, raw material and finished product specifications, master batch records and documentation control.

Responsibilities

  • 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. Investigate process anomalies.
  • Write and/or review Operation Procedures, Master Manufacturing Formula and other QA-controlled documents for all Departments under a QMS. Coordinate the security and availability of the approved documents to all Departments.
  • Lead the Material Review Board at which process and product deviations are reviewed for thorough root cause investigation, identification of root cause, and determination of appropriate CAPA.
  • Provide training to operations personnel regarding CAPA and other quality system topics.
  • Assist in the technology transfer process by providing technical input throughout the development and scale-up to commercial scale for new products governed by GMP or ISO based Quality Management Systems.
  • Review customer requests for product agreements pertaining to product specifications, testing protocols, label and documentation requirements.
  • Participate in internal audits according to ISO and GMP.
  • Approve Master Batch Records
  • Review and approve Raw Material and Finished Product Specifications
  • Respond to quality-related customer inquiries.
  • Present various GMP quality systems training topics to production, laboratory and quality personnel.
  • Assist in the resolution of customer complaints pertaining to quality and process related issues.
  • Assist with recalls and field corrections as needed.
  • Participate in governmental regulatory audits as needed.
  • Interact with the production and laboratory personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers.
  • Lead Project or Process Improvement initiatives

 

 

Who You Are

  • Bachelors degree in Life Sciences with 5+ years experience or bachelors degree in a non-science with at least 7+ years applicable GMP / ISO experience in pharmaceutical or health care industry. 
  • Must have a good understanding of ICH Q7 or GMP Guidelines
  • Understanding of Quality Control test methodology and the associated analytical results. 
  • Excellent interpersonal skills for interacting with many internal departments and management levels, along with customers, suppliers and regulatory authorities
  • Ability to organize and prioritize tasks effectively.
  • Capacity for independent work
  • Good time management and negotiating skills required
  • Good computer skills

 


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.

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