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LIMS Data System Engineer

Your Role:

Cherokee Quality Control in St. Louis, MO, supports manufacturing of custom products including active pharmaceutical ingredients, excipients, and raw materials used within the health care industry. This position within the GMP Quality Control department is responsible to support the development, validation, implementation and ongoing administrator support of a LIMS (Laboratory Information Management System) and other data systems. 

 

  • Support the development, validation and implementation of a LIMS for a GMP laboratory.
  • Draft and review policy, procedures and protocols as assigned.
  • Author, execute, and/or review of scripts and test data associated with the validation of various software systems in the GMP laboratory.
  • Work in accordance with current GMPs and GAMP requirements.
  • Lead technical troubleshooting of data systems.
  • Lead process improvements to improve laboratory performance.
  • Prepare technical reports as assigned.
  • Manage project milestones for internal and external customers to ensure on quality and on time success.
  • Additional duties as assigned by QC Management.

 

Physical Attributes:

  • Work in a chemical environment
  • Ability to perform tasks while wearing personal protective equipment (chemical protective clothing) for extended periods of time


Who You Are:

 

Minimum Qualifications:

  • BS/BA in a related life science or computer science field

 

Preferred Qualifications:

  • MS degree in a related life science or computer science field
  • Experience with the validation, implementation and maintenance of various computer software systems in a GMP laboratory
  • GMP experience in pharmaceutical, biopharmaceutical or similar industry
  • GMP administration experience in LIMS, database, and/or CDS (Chromatography Data System)
  • GMP experience with validation and the change control associated with validated computerized systems
  • Strong understanding of GMP guidance and regulations for APIs, excipients and drug products
  • Strong understanding of data integrity requirements, including the review of electronic audit trails
  • Strong technical writing, root cause analysis and scientific reasoning
  • Experience in lean lab practices and continuous improvement initiatives
  • GMP experience with ELN (Electronic Lab Notebooks)

 

RSRMS

Job Requisition ID:  212103
Location:  St. Louis
Career Level:  E - Professional (10+ 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.


Job Segment: Database, Pharmaceutical, Computer Science, Laboratory, Testing, Technology, Science

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