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Quality Control Microbiology Scientist

Your Role

The Quality Control Microbiology Department at this site supports quality functions for Active Pharmaceutical Ingredients (APIs) under Good Manufacturing Practice guidelines (ICHQ7).

The Quality Control Scientist is responsible for overseeing and leading microbiological investigations including but not limited to Non-conformance deviations, CAPA, and OOS investigations associated with in-process and release Bacterial Endotoxin Test, Bioburden tests, and Environmental monitoring. samples. The QC Scientist must demonstrate strong technical knowledge, be familiar with Scientific/regulatory principles, possess initiative, and maintain a strong commitment to scientific excellence.

  • Manage Microbiology department’s CAPA, OOS and Deviation trends
  • Lead and perform QC microbiological deviation investigations to adequately identify root cause and assign appropriate corrective and preventative actions (CAPAs) to prevent recurrence
  • Lead and write out-of-specification (OOS/ out-of-trend (OOT) investigations
  • Interact with the production and laboratory personnel to ensure adequate Root Cause is identified.
  • Work within various internal departments to improve and execute processes used in an ICHQ7 environment
  • Documentation Control: write, review, and approve Operating Procedures, Specifications, and other QC controlled documents
  • Occasionally support and perform detailed data review for test results on assays such as Bioburden, Endotoxin, and Environmental Monitoring, generated by the QC microbiology department for compliance with cGMP, internal OPs and Specifications to support production, stability studies and lab operation.

 

 

Who You Are:

 

Minimum Qualifications:

  • Bachelor’s degree in Microbiology or Biology or another life science discipline
  • 5+ years of Microbiology experience within a cGMP environment
  • 5+ years of work experience in pharmaceuticals, biologics, microbiology, or aseptic manufacturing
  • 1+ years of experience in reviewing microbiological assays and/or environmental monitoring data in a cGMP Quality Control lab
  • 1+ years of experience working with ICH Q7

 

 

Preferred Qualifications:

  • Master’s degree in Microbiology or Biology highly preferred
  • Experience in Biologics or drug product testing is preferred.
  • Current API (Biologics/bioorganic) knowledge and/or experience desired.
  • Knowledge of 21CFR210 and ICH Q7.
  • Experience in USP<61>, USP<85>, EP pharmacopeia requirements.
  • Experience using RCA tools such as Fishbone, 5Whys, and pareto charts
  • Experience in Aseptic manufacturing Environmental monitoring
  • Experience in execution of OOS/OOT investigations, CAPA and non-conformance deviations
  • Good computer skills, including proficiency in MS Word, MS Excel, MS PowerPoint, and the ability to learn and operate other specific application software, required
  • Excellent written and verbal communication and customer interface skills
  • Excellent writing skills and experience writing technical documentation and reports

 

RSRMS

Job Requisition ID:  208166
Location:  St. Louis
Career Level:  D - Professional (4-9 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 HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

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