QA Specialist

Posted 29 Aug 2019

St. Louis, Missouri - United States

Req Id 196604

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 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.


Who We Are: MilliporeSigma is the North American life science brand of Merck KGaA, Darmstadt, Germany – a leading science and technology company. It offers a broad range of innovative products and services to biotech and pharmaceutical drug therapies businesses. Through dedicated collaboration with the scientific and engineering communities, and as one of the top three R&D investors in the life science tools industry, the brand serves as a strategic partner to customers and helps advance the promise of life science.
 

This position is located at the Cherokee site in St. Louis, Mo.  The Quality Assurance Department at this site supports quality functions for Active Pharmaceutical Ingredients (APIs) under Good Manufacturing Practice guidelines (ICHQ7)

 

Your role:

Support Quality management systems at a site manufacturing custom Active Pharmaceutical Ingredients (API) in accordance to ICH Q7 and cGMP regulations. In support of site wide objectives this role will participate in varying degrees creating processes and maintaining adherence to quality systems such as change management, supplier quality, complaint management, applications for document management, training and deviation/CAPA management, audit management for regulatory agencies, customers, corporate and internal, and general validation guidance on cleaning, equipment and process activities.in accordance with established quality systems.

 

This position will be focused on Supplier Qualification Management, including but not limited to performance of audits, risk asessments, report generation, and managment of the site's Approved Supplier List.  Individual should be well versed with auditing technique as well as the GMP and ISO quality system principals. 

 

Who you are:

 

Basic Qualifications:

  • B.S./B.A. in the Life Sciences, Chemistry, or Chemical Engineering with 3+ years experience (i.e. GMP or API environment), B.S./B.A. in a non-science with at least 10 years applicable Quality System (i.e. GMP or API environment)
  •  Must have a good understanding GMP guidelines for the pharma industry such as ICH Q7, 21CFR 210 and 211, EU Annex chapters.

 

Prefered Qualifications:

 

  •  Understanding of Quality Control test methodology and the associated analytical results. 
  • Familiar with the accuracy and precision of various common analytical methods.
  • 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 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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