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Quality Assurance Associate Specialist
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.
US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by The Company. The Company uses the definition of fully vaccinated assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
The Quality Assurance Associate Specialist at MilliporeSigma in Lenexa will 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 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 are not limited to reviewing and release of raw materials and finished products in a timely manner, assuring any lot deviations and Out of Specifications (OOS) is 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, 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 assist periodic internal audits to meet corporate and ISO requirements.
In addition, this role will be responsible for approving 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 and ISO training, and maintaining Site Quality filing systems.
Who you are:
- Bachelor’s Degree in life sciences or related field
- 1+ year direct Quality Assurance experience in a GMP environment
- 2+ years of experience in a Pharmaceutical, Biopharm, or other Healthcare
- 3+ years of experience in a Pharmaceutical, Biopharm, or other Healthcare industry with the demonstrable familiarity of cGMP’s, cGLP’s and/or related ISO requirements
- Experience using QMS software such as TrackWise or SAP QN
- Quality Auditor Certification or the ability to obtain certification
- An understanding of commercial Quality systems and their application in a manufacturing environment
- Good customer service skills and the ability to negotiate win-win outcomes
- Previous experience as an auditor of supplier products and services
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
If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
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.