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Quality Assurance Specialist

Your Role:

 

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 (ICH Q7). This individual will work with various internal departments to improve and execute processes used in an ICHQ7 environment. 

 

  • Review Root Cause Analysis investigations and ensure adequate CAPAs are put in place to reduce or eliminate recurrence of issues. 
  • Documentation Control: write, review, and approve Operating Procedures, Specifications, Master Manufacturing Procedures, and other QA controlled documents
  • Ensure that all aspects of product release meet analytical, production, packaging, and labeling specifications in accordance with established quality systems
  • Provide extensive review of manufacturing and quality control batch records, including verifications of calculations, approval of MMFs, MPFs, generation of Certificates of Analysis, and other release documents.
  • Interact with the production and laboratory personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers.
  • Respond to quality-related customer questions.

 

Who You Are:

 

Minimum Qualifications:

  • Bachelor of Science or Arts Degree in Life Sciences, Chemistry, Pharmacy, Chemical, Process Engineering or related Life Science discipline
  • 2+ years of experience working in an ICH Q7 cGMP environment
     

Preferred Qualifications:

  • Current API knowledge/experience
  • Good computer skills
  • Excellent written and verbal communication and customer interface skills
  • Ability to multi-task
  • Good problem-solving skills
  • Good time management
  • Experience with Environmental Monitoring 

RSRMS

Job Requisition ID:  206588
Location:  St. Louis
Career Level:  C - Professional (1-3 years)
Working time model:  full-time

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: QA, Quality Assurance, Pharmacy, Pharmaceutical, Quality, Technology, Healthcare, Science

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