Quality Assurance Specialist

Job description

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 position is located at the Cherokee facility 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:

This individual will work various internal departments to improve and execute processes in compliance with cGMP regulations in 21CFR 210, 211, Part 11 and in ICH Q7.

Duties in this role will include:

* Write, review, and approve Investigations, OOS (out-of-specification), OOT (out-of-trend), complaints, CAPAs and Change Controls.
* Participate in internal/external audits as needed.
* Provide quality oversight and support for new product introductions as primary quality point of contact. Respond to quality-related customer questions.
* Write, review, and approve Operating Procedures, Manufacturing documents, Technical Transfer Protocols, and other controlled documents under a Quality Managed System (QMS).
* Review batch records for completeness and accuracy based on GMP requirements to ensure acceptable product and process consistency.
* Interact with production and laboratory personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers.
* Monitor for quality related issues and collaborate on resolution as quality on the floor.
* Lead Process Improvement for Quality related initiatives/projects.

Who you are:

Minimum Requirements:

Bachelor's Degree in Life Sciences, Chemistry, Pharmacy, Chemical Engineering, Process Engineering, or other life science related discipline AND 5+ years industry experience

OR

Master's Degree in Life Sciences, Chemistry, Pharmacy, Chemical Engineering, Process Engineering, or other life science related discipline AND 2+ years industry experience

Preferred Qualifications:

* Knowledge of ICHQ7 and API knowledge &/or experience
* TrackWise and SAP experience
* Proficiency in MS Word, MS Excel, MS PowerPoint and ability to learn and operate using other specific application software
* Excellent communication (verbal & written) and customer interface skills
* Excellent writing skills and experience writing technical documentation & reports
* Ability to simultaneously manage multiple tasks/priorities
* Good problem-solving skills/abilities
* Good time management and negotiating skills
* Capacity for independent work required.
* Data analysis, presentation, and experimental design knowledge

Additional Local need:

Environmental conditions will vary depending on specific job responsibilities; typically, 70-90% Office Environment, 10-30% Production, QC, Packaging.

RSRMS

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!

Our Benefits -

Curious? Apply and find more information at

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 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.