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Sr. Quality Assurance Specialist -- El Camino 1

 

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

As a member of the Client Facing Quality Assurance team, you will be responsible for the critical, quality review and disposition of raw materials and product batch records. In this role, you will effectively communicate with clients, independently manage timelines, and continually strengthen client relations. You will also work independently within prescribed guidelines and collaboratively as part of a team as well as be able to obtain direction and commitment to ensure that projects are completed by deadlines and streamlining processes to maximize productivity. This role will work successfully, strategically and tactically in a fast-paced, multi-disciplinary environment with the potential for rapidly changing priorities. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions. Off-shift, weekend, and overtime duties may be assigned by the manager of the employee.

 

  • GMP Batch Record Review
  • Reviewing process validation documentation
  • Logging and monitoring quality-related data
  • Authoring and reviewing SOPs and other controlled documents
  • Other Quality Assurance related duties and projects as assigned

 

 

Who You Are:

Minimum Qualifications:

  • Bachelor’s Degree in Biology, Chemistry or another Scientific discipline
  • 3+ years of experience in Biologics, Biotech, Pharmaceuticals or Medical Devices.
  • 3+ years of experience working within Quality in a cGMP environment
  • 2+ years of experience creating, revising, reviewing, and approving of controlled documentation
  • 1+ years of experience supporting client audits and regulatory inspections

 

Preferred Qualifications:

  • 1+ years of Contract Manufactured Organization (CMO) experience
  • Batch record review
  • Knowledge of cGMP guidelines and regulations relating to the manufacturing of biologics and pharmaceuticals
  • Manufacturing or Cleanroom experience
  • Experience performing internal audits
  • Excellent attention to detail, with superior documentation and organization skills
  • Excellent computer, verbal, and written communication skills, including strong technical writing ability

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!

 

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:  230451
Location:  Carlsbad
Career Level:  C - Professional (1-3 years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
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.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday.

Notice on Fraudulent Job Offers
Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information.


Job Segment: Medical, Biotech, QA, Quality Assurance, Healthcare, Quality, Science, Technology

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