Sr. Quality Assurance Associate

Posted 13 Mar 2019

Lenexa, Kansas - United States

Req Id 185752

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 51,000 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. EMD Performance Materials 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 (internal, supplier, and customer), training, environmental monitoring, water monitoring, document change control, specifications, master batch records. Make batch release determination, and generate CoA and other specified batch documents.

JOB FUNCTIONS:

  • Review and release raw materials in a timely manner, assuring any lot deviations and Out of Specifications (OOS) are completed and closed.
  • Label approval, label generation, and review of daily QA paperwork to include charts, monitoring exhibits, and environmental records.
  • Review batch records prior to production.
  • Review and release finished products in a timely manner, assuring any lot deviations are completed and closed.
  • Answer questions from internal and external customers.
  • Participate in cross-functional deviation investigations, root cause analysis, and CAPA plan development in a timely manner. Maintain CAPA tracking and perform effectiveness check as applicable.
  • Generate Quality System Metrics.
  • Participate in customer and ISO audits including opening/closing meetings, tours, document review and any follow-up activities, as necessary.
  • Occasionally perform audits of suppliers as part of the global auditing team. Inform suppliers of audit observations and any follow-up activities as necessary.
  • Conduct periodic internal audits to meet regulatory requirements.
  • Approve master batch records and batch records, assuring accuracy and completeness. Resolve any discrepancies in documentation.
  • Review and approve product specifications.
  • Takes part in and contributes to a safe working environment by following corporate and departmental safety regulations.
  • Perform new hire, ISO, and GMP training.
  • Maintain Site Quality filing systems as necessary.

Who You Are

  • Bachelor’s Degree in life sciences with a minimum of 3 - 4 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.
  • Previous experience as an auditor of supplier products and services.

Basic Qualifications:

  • Bachelor’s Degree in life sciences or related field with a minimum of 3 - 4 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.
  • Previous experience as an auditor of supplier products and services.

PREFERRED:

  • More than 4 years experience in a Pharmaceutical, Biopharm, or other Healthcare industry with demonstrable familiarity of cGMP’s, cGLP’s and/or related ISO requirements.
  • Quality Auditor Certification or the ability to obtain certification.

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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