Sr. QA Specialist
MilliporeSigma

Cleveland, Ohio

Posted in Science and Research


This job has expired.

Job Info


A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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:

This role is the Quality Assurance Department of our facility in Cleveland, Ohio reporting to the QA Supervisor.The Sr. Quality Assurance Associate Specialist supports the needs of the Cleveland site by serving as a contact for routine QA activities and inquiries. Additionally, in this role you will help to maintain and improve Cleveland Quality Systems such as auditing (internal, supplier and customer), training, validation, supplier management, change control, complaints, NCR, and CAPAs. You will also review production, packaging and QC records and dispositions final product against applicable specifications in accordance with established procedures.

  • Record review and product disposition
  • Report all process deviations and / or laboratory OOS results and investigate process anomalies
  • Routinely support ongoing process improvements with the department and organization to ensure efficient and value-added processes
  • Oversee NCR and CAPA system to ensure appropriate investigations are conducted and CAPAs implemented in a timely manner
  • Restrict non-conforming products from sale as needed and assist with recall / field corrective actions
  • Assist with data integrity program development and implementation
  • Investigate and resolve customer complaints, participating in calls with customers and respond to quality related questions from customers
  • Review and approve all quality system related documents
  • Represent site and corporate quality systems during customer audits and coordinate responses to customer audit reports in a timely manner
  • Perform and document internal and supplier audits
  • Present various quality topics to operational, laboratory, and other personnel

Who you are:

Basic Qualifications:
  • Bachelor's Degree in Chemistry, Biology or related science field
  • 5+ years of quality experience within the pharmaceutical or biotech industry

Preferred Qualifications:
  • SAP and TrackWise
  • GMP quality experience
  • Good communication skills - able to communicate to all levels across technical and non-technical functions.
  • Ability to influence people in absence of direct positional authority.
  • Ability to create and deliver presentations
  • Computer proficiency
  • Experience interacting with a broad range of people across all levels, including line staff, supervision, and management from all departments
  • Comfortability with delivering some training to both individuals and potentially large groups
  • IT acumen
  • Ability to take ideas and turn them into reality, with limited direction and feedback

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.

Job Requisition ID: 222909

Location: Cleveland

Career Level: C - Professional (1-3 years)

Working time model: full-time


This job has expired.

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